<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03832907</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00107627</org_study_id>
    <nct_id>NCT03832907</nct_id>
  </id_info>
  <brief_title>Dexcom G6 Observational Study</brief_title>
  <official_title>Inpatient and Post-hospital Discharge Assessment of Glycemic Control by Capillary Point-of-care Glucose Testing and by Continuous Glucose Monitoring in Insulin-treated Patients With Type 1 and Type 2 Diabetes: Dexcom G6 Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an exploratory prospective study primary aiming to evaluate differences between&#xD;
      Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose&#xD;
      Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2)&#xD;
      identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2&#xD;
      diabetes treated with basal bolus insulin regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several studies have shown that the use of a device that can measure blood glucose levels&#xD;
      every 5 minutes is more effective in identifying low blood glucose (hypoglycemia) and high&#xD;
      blood glucose (hyperglycemia) when compared to regular measurements with fingersticks [point&#xD;
      of care (POC)].&#xD;
&#xD;
      This is an exploratory prospective study primary aiming to evaluate differences between&#xD;
      Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose&#xD;
      Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2)&#xD;
      identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2&#xD;
      diabetes treated with basal bolus insulin regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Daily Blood Glucose by POC Reading сompared to CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Mean daily blood glucose will be calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Clinical Significant Hypoglycemia (&lt;54 mg/dl) Events by POC Reading Compared to CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Number of clinical significant hypoglycemia (&lt;54 mg/dl) events will be calculated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Severe Hyperglycemia (&gt;240 mg/dl) Events by POC Reading Compared to CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Number of severe hyperglycemia (&gt;240 mg/dl) events will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Daily Blood Glucose by POC Reading Compared to CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Mean daily blood glucose will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Clinical Significant Hypoglycemia (&lt;54 mg/dl) Events by POC Reading Compared to CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Number of clinical significant hypoglycemia (&lt;54 mg/dl) events will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Clinical Significant Severe Hyperglycemia (&gt;240 mg/dl) Events by POC Reading Compared to CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Number of severe hyperglycemia (&gt;240 mg/dl) events will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Nocturnal Hypoglycemic Events &lt; 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Number of nocturnal hypoglycemic events &lt; 70 mg/dl (between 22:00 and 06:00) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Nocturnal Hypoglycemic Events &lt; 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Number of nocturnal hypoglycemic events &lt; 70 mg/dl(between 22:00 and 06:00) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of of Hypoglycemic Events &lt; 70mg/dl in POC Group by POC Reading Compared to CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Number of of hypoglycemic events &lt; 70mg/dl will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hypoglycemic Events &lt; 70mg/dl by POC Reading Compared to CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Number of of hypoglycemic events &lt; 70mg/dl will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Hyperglycemia (Minutes) During the Day and Night&gt; 240 mg/dl by CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Time in hyperglycemia (minutes) during the day and night&gt; 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in Hyperglycemia (Minutes) During the Day and Night&gt; 240 mg/dl by CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Time in hyperglycemia (minutes) during the day and night&gt; 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hyperglycemic Events &gt; 240 mg/dl by POC Reading Compared to CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Number of hyperglycemic events &gt; 240 mg/dl will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hyperglycemic Events &gt; 240 mg/dl by POC Reading Compared to CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Number of hyperglycemic events &gt; 240 mg/dl will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;70mg/dl by CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of patients with greater than 5%-time below glucose target &lt;70mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;70 mg/dl by CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Percentage of patients with greater than 5%-time below glucose target &lt;70 mg/dl will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;180mg/dl by CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of patients with greater than 5%-time above glucose target &gt;180 mg/dl will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;180 mg/dl by CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Percentage of patients with greater than 5%-time above glucose target &gt;180 will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Variability Calculated by Standard Deviation by CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Glycemic variability will be calculated using Standard Deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Variability Calculated by MAGE by CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Sensor Removal/Failures/Dislodgments</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Number of sensor removal/failures/dislodgments will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Absolute Relative Difference (MARD) of CGM Compared to POC</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values &lt; 70 mg/d Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values in the hypoglycemic range (&lt;70 mg/dl) meeting %30/30 accuracy criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm</measure>
    <time_frame>During hospital stay (3 days - up to 30 days) measured in arm</time_frame>
    <description>Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Nocturnal Hypoglycemic Events &lt; 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Number of nocturnal hypoglycemic events &lt; 54 mg/dl (between 22:00 and 06:00) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Nocturnal Hypoglycemic Events &lt; 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Number of nocturnal hypoglycemic events &lt; 54 mg/dl(between 22:00 and 06:00) will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of of Hypoglycemic Events &lt; 54 in POC Group by POC Reading Compared to CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Number of of hypoglycemic events &lt; 54 will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hypoglycemic Events &lt; 54mg/dl by POC Reading Compared to CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Number of of hypoglycemic events &lt; 54mg/dl will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;54mg/dl by CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of patients with greater than 5%-time below glucose target &lt;54mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;240 mg/dl by CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Percentage of patients with greater than 5%-time above glucose target &gt;240 will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;240 mg/dl by CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of patients with greater than 5%-time above glucose target &gt;240 mg/dl will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Variability Calculated by MAGE by CGM Reading</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>The average amplitude of glycemic excursions with values exceeding a certain threshold.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;54 mg/dl by CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Percentage of patients with greater than 5%-time below glucose target &lt;54 mg/dl will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values within the 70-140 mg/dl range that meet %30/30 accuracy criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values within the 140-180 mg/dl range that meet %30/30 accuracy criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values &gt; 180 mg/dl, Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values in the hyperglycemic range (&gt;180 mg/dl) that meet %30/30 accuracy criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic Variability Calculated by Standard Deviation by CGM Reading</measure>
    <time_frame>10 days post discharge</time_frame>
    <description>Glycemic variability will be calculated using Standard Deviation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values &lt; 70 mg/dl Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values in the hypoglycemic range (&lt;70 mg/dl) that meet %20/20 accuracy criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values within the 70-140 mg/dl range that meet %20/20 accuracy criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values &gt; 180 mg/dl, Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values in the hyperglycemic range (&gt;180 mg/dl) that meet %20/20 accuracy criteria..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values within the 140-180 mg/dl range that meet %20/20 accuracy criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values &lt; 70 mg/dl Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values in the hypoglycemic range (&lt;70 mg/dl) that meet %15/15 accuracy criteria..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values within the 70-140 mg/dl range that meet %15/15 accuracy criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values within the 140-180 mg/dl range that meet %15/15 accuracy criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values &gt; 180 mg/dl, Compared to the Standard-of-care POC BG</measure>
    <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
    <description>Percentage of CGM glucose values in the hyperglycemic range (&gt;180 mg/dl) that meet %15/15 accuracy criteria.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Dexcom G6 CGM - Continues Glucose Monitoring sensor system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Dexcom G6 CGM is a commercially available factory-calibrated sensor system. The system measures interstitial glucose every 5-15 minutes, providing real-time and more complete glycemic profile during 24-hours compared to standard POC glucose testing, and replaces the need for finger sticking. Potential limitations include the need for removing the sensor before MRI or diathermy treatment, and the potential interference in patients with severe dehydration.&#xD;
In parallel, same participants will be monitored by the standard of care point-of-care (POC) capillary glucose tests. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom G6 CGM - Continues Glucose Monitoring sensor system</intervention_name>
    <description>A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.</description>
    <arm_group_label>Dexcom G6 CGM - Continues Glucose Monitoring sensor system</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>POC BG - Point-of-Care Blood Glucose monitoring</intervention_name>
    <description>Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
    <arm_group_label>Dexcom G6 CGM - Continues Glucose Monitoring sensor system</arm_group_label>
    <other_name>Standard of Care capillary glucose test</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. &gt; 18 years admitted to a general medicine or surgical service.&#xD;
&#xD;
          2. Known history of T1D or T2D receiving insulin therapy&#xD;
&#xD;
          3. Subjects must have a randomization BG between 140 mg and 400 mg/dL without laboratory&#xD;
             evidence of diabetic ketoacidosis (bicarbonate &lt; 18 mEq/L, pH &lt; 7.30, or positive&#xD;
             serum or urinary ketones).&#xD;
&#xD;
          4. Patients with expected hospital length-of-stay of 3 or more days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with acute illness admitted to the ICU or expected to require admission to&#xD;
             the ICU.&#xD;
&#xD;
          2. Patients expected to require MRI procedures during hospitalization.&#xD;
&#xD;
          3. Mental condition rendering the subject unable to understand the nature, scope, and&#xD;
             possible consequences of the study.&#xD;
&#xD;
          4. Female subjects who are pregnant or breast-feeding at time of enrollment into the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillermo Umpierrez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <results_first_submitted>March 31, 2021</results_first_submitted>
  <results_first_submitted_qc>August 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2021</results_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Guillermo Umpierrez, MD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Glucose monitoring</keyword>
  <keyword>POC BG</keyword>
  <keyword>DexcomG6 CGM</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/07/NCT03832907/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
          <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
          <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="101"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Daily Blood Glucose by POC Reading сompared to CGM Reading</title>
        <description>Mean daily blood glucose will be calculated</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Daily Blood Glucose by POC Reading сompared to CGM Reading</title>
          <description>Mean daily blood glucose will be calculated</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175.55" spread="42.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175.84" spread="42.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Clinical Significant Hypoglycemia (&lt;54 mg/dl) Events by POC Reading Compared to CGM Reading</title>
        <description>Number of clinical significant hypoglycemia (&lt;54 mg/dl) events will be calculated</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Clinical Significant Hypoglycemia (&lt;54 mg/dl) Events by POC Reading Compared to CGM Reading</title>
          <description>Number of clinical significant hypoglycemia (&lt;54 mg/dl) events will be calculated</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Severe Hyperglycemia (&gt;240 mg/dl) Events by POC Reading Compared to CGM Reading</title>
        <description>Number of severe hyperglycemia (&gt;240 mg/dl) events will be recorded</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Severe Hyperglycemia (&gt;240 mg/dl) Events by POC Reading Compared to CGM Reading</title>
          <description>Number of severe hyperglycemia (&gt;240 mg/dl) events will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="518"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Daily Blood Glucose by POC Reading Compared to CGM Reading</title>
        <description>Mean daily blood glucose will be calculated</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Daily Blood Glucose by POC Reading Compared to CGM Reading</title>
          <description>Mean daily blood glucose will be calculated</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175.55" spread="42.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173.13" spread="41.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Clinical Significant Hypoglycemia (&lt;54 mg/dl) Events by POC Reading Compared to CGM Reading</title>
        <description>Number of clinical significant hypoglycemia (&lt;54 mg/dl) events will be calculated</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Clinical Significant Hypoglycemia (&lt;54 mg/dl) Events by POC Reading Compared to CGM Reading</title>
          <description>Number of clinical significant hypoglycemia (&lt;54 mg/dl) events will be calculated</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM (arm)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Clinical Significant Severe Hyperglycemia (&gt;240 mg/dl) Events by POC Reading Compared to CGM Reading</title>
        <description>Number of severe hyperglycemia (&gt;240 mg/dl) events will be recorded</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Clinical Significant Severe Hyperglycemia (&gt;240 mg/dl) Events by POC Reading Compared to CGM Reading</title>
          <description>Number of severe hyperglycemia (&gt;240 mg/dl) events will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Nocturnal Hypoglycemic Events &lt; 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</title>
        <description>Number of nocturnal hypoglycemic events &lt; 70 mg/dl (between 22:00 and 06:00) will be recorded</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Nocturnal Hypoglycemic Events &lt; 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</title>
          <description>Number of nocturnal hypoglycemic events &lt; 70 mg/dl (between 22:00 and 06:00) will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Nocturnal Hypoglycemic Events &lt; 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</title>
        <description>Number of nocturnal hypoglycemic events &lt; 70 mg/dl(between 22:00 and 06:00) will be recorded</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Nocturnal Hypoglycemic Events &lt; 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</title>
          <description>Number of nocturnal hypoglycemic events &lt; 70 mg/dl(between 22:00 and 06:00) will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of of Hypoglycemic Events &lt; 70mg/dl in POC Group by POC Reading Compared to CGM Reading</title>
        <description>Number of of hypoglycemic events &lt; 70mg/dl will be recorded</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of of Hypoglycemic Events &lt; 70mg/dl in POC Group by POC Reading Compared to CGM Reading</title>
          <description>Number of of hypoglycemic events &lt; 70mg/dl will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hypoglycemic Events &lt; 70mg/dl by POC Reading Compared to CGM Reading</title>
        <description>Number of of hypoglycemic events &lt; 70mg/dl will be recorded</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hypoglycemic Events &lt; 70mg/dl by POC Reading Compared to CGM Reading</title>
          <description>Number of of hypoglycemic events &lt; 70mg/dl will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading</title>
        <description>Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading</title>
          <description>Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .</description>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119.08" spread="216.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.63" spread="135.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading</title>
        <description>Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading</title>
          <description>Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .</description>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.70" spread="217.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.14" spread="140.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Hyperglycemia (Minutes) During the Day and Night&gt; 240 mg/dl by CGM Reading</title>
        <description>Time in hyperglycemia (minutes) during the day and night&gt; 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Hyperglycemia (Minutes) During the Day and Night&gt; 240 mg/dl by CGM Reading</title>
          <description>Time in hyperglycemia (minutes) during the day and night&gt; 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .</description>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="972.30" spread="1214.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="723.23" spread="1061.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time in Hyperglycemia (Minutes) During the Day and Night&gt; 240 mg/dl by CGM Reading</title>
        <description>Time in hyperglycemia (minutes) during the day and night&gt; 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Hyperglycemia (Minutes) During the Day and Night&gt; 240 mg/dl by CGM Reading</title>
          <description>Time in hyperglycemia (minutes) during the day and night&gt; 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.</description>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4624.3" spread="13554"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1706.1" spread="2255.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hyperglycemic Events &gt; 240 mg/dl by POC Reading Compared to CGM Reading</title>
        <description>Number of hyperglycemic events &gt; 240 mg/dl will be recorded</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hyperglycemic Events &gt; 240 mg/dl by POC Reading Compared to CGM Reading</title>
          <description>Number of hyperglycemic events &gt; 240 mg/dl will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="518"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hyperglycemic Events &gt; 240 mg/dl by POC Reading Compared to CGM Reading</title>
        <description>Number of hyperglycemic events &gt; 240 mg/dl will be recorded</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hyperglycemic Events &gt; 240 mg/dl by POC Reading Compared to CGM Reading</title>
          <description>Number of hyperglycemic events &gt; 240 mg/dl will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="554"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading</title>
        <description>Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading</title>
          <description>Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated</description>
          <units>percentage of readings</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.70" spread="24.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM (abdomen)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.91" spread="26.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.97" spread="28.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading</title>
        <description>Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading</title>
          <description>Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated</description>
          <units>percentage of readings</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.56" spread="29.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.62" spread="30.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.60" spread="31.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;70mg/dl by CGM Reading</title>
        <description>Percentage of patients with greater than 5%-time below glucose target &lt;70mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;70mg/dl by CGM Reading</title>
          <description>Percentage of patients with greater than 5%-time below glucose target &lt;70mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.</description>
          <units>percentage of readings</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM &lt;70 abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM &lt;70 arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;70 mg/dl by CGM Reading</title>
        <description>Percentage of patients with greater than 5%-time below glucose target &lt;70 mg/dl will be calculated</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;70 mg/dl by CGM Reading</title>
          <description>Percentage of patients with greater than 5%-time below glucose target &lt;70 mg/dl will be calculated</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;180mg/dl by CGM Reading</title>
        <description>Percentage of patients with greater than 5%-time above glucose target &gt;180 mg/dl will be calculated</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;180mg/dl by CGM Reading</title>
          <description>Percentage of patients with greater than 5%-time above glucose target &gt;180 mg/dl will be calculated</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;180 mg/dl by CGM Reading</title>
        <description>Percentage of patients with greater than 5%-time above glucose target &gt;180 will be calculated</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;180 mg/dl by CGM Reading</title>
          <description>Percentage of patients with greater than 5%-time above glucose target &gt;180 will be calculated</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glycemic Variability Calculated by Standard Deviation by CGM Reading</title>
        <description>Glycemic variability will be calculated using Standard Deviation</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemic Variability Calculated by Standard Deviation by CGM Reading</title>
          <description>Glycemic variability will be calculated using Standard Deviation</description>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.37" spread="15.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.37" spread="15.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glycemic Variability Calculated by MAGE by CGM Reading</title>
        <description>MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold.</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemic Variability Calculated by MAGE by CGM Reading</title>
          <description>MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold.</description>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.33" spread="24.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55" spread="23.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Sensor Removal/Failures/Dislodgments</title>
        <description>Number of sensor removal/failures/dislodgments will be recorded</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Sensor Removal/Failures/Dislodgments</title>
          <description>Number of sensor removal/failures/dislodgments will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Absolute Relative Difference (MARD) of CGM Compared to POC</title>
        <description>Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Absolute Relative Difference (MARD) of CGM Compared to POC</title>
          <description>Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC</description>
          <units>percent difference</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.54" spread="15.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.22" spread="15.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values &lt; 70 mg/d Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values in the hypoglycemic range (&lt;70 mg/dl) meeting %30/30 accuracy criteria.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values &lt; 70 mg/d Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values in the hypoglycemic range (&lt;70 mg/dl) meeting %30/30 accuracy criteria.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen</title>
        <description>Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen</title>
          <description>Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm</title>
        <description>Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.</description>
        <time_frame>During hospital stay (3 days - up to 30 days) measured in arm</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm</title>
          <description>Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>D</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Nocturnal Hypoglycemic Events &lt; 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</title>
        <description>Number of nocturnal hypoglycemic events &lt; 54 mg/dl (between 22:00 and 06:00) will be recorded</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Nocturnal Hypoglycemic Events &lt; 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</title>
          <description>Number of nocturnal hypoglycemic events &lt; 54 mg/dl (between 22:00 and 06:00) will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Nocturnal Hypoglycemic Events &lt; 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</title>
        <description>Number of nocturnal hypoglycemic events &lt; 54 mg/dl(between 22:00 and 06:00) will be recorded</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Nocturnal Hypoglycemic Events &lt; 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading</title>
          <description>Number of nocturnal hypoglycemic events &lt; 54 mg/dl(between 22:00 and 06:00) will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of of Hypoglycemic Events &lt; 54 in POC Group by POC Reading Compared to CGM Reading</title>
        <description>Number of of hypoglycemic events &lt; 54 will be recorded</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of of Hypoglycemic Events &lt; 54 in POC Group by POC Reading Compared to CGM Reading</title>
          <description>Number of of hypoglycemic events &lt; 54 will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hypoglycemic Events &lt; 54mg/dl by POC Reading Compared to CGM Reading</title>
        <description>Number of of hypoglycemic events &lt; 54mg/dl will be recorded</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hypoglycemic Events &lt; 54mg/dl by POC Reading Compared to CGM Reading</title>
          <description>Number of of hypoglycemic events &lt; 54mg/dl will be recorded</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;54mg/dl by CGM Reading</title>
        <description>Percentage of patients with greater than 5%-time below glucose target &lt;54mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;54mg/dl by CGM Reading</title>
          <description>Percentage of patients with greater than 5%-time below glucose target &lt;54mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM &lt;70 abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM &lt;70 arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;240 mg/dl by CGM Reading</title>
        <description>Percentage of patients with greater than 5%-time above glucose target &gt;240 will be calculated</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;240 mg/dl by CGM Reading</title>
          <description>Percentage of patients with greater than 5%-time above glucose target &gt;240 will be calculated</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;240 mg/dl by CGM Reading</title>
        <description>Percentage of patients with greater than 5%-time above glucose target &gt;240 mg/dl will be calculated</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Greater Than 5%-Time Above Glucose Target &gt;240 mg/dl by CGM Reading</title>
          <description>Percentage of patients with greater than 5%-time above glucose target &gt;240 mg/dl will be calculated</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glycemic Variability Calculated by MAGE by CGM Reading</title>
        <description>The average amplitude of glycemic excursions with values exceeding a certain threshold.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemic Variability Calculated by MAGE by CGM Reading</title>
          <description>The average amplitude of glycemic excursions with values exceeding a certain threshold.</description>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.73" spread="27.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.68" spread="30.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;54 mg/dl by CGM Reading</title>
        <description>Percentage of patients with greater than 5%-time below glucose target &lt;54 mg/dl will be calculated</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Greater Than 5%-Time Below Glucose Target &lt;54 mg/dl by CGM Reading</title>
          <description>Percentage of patients with greater than 5%-time below glucose target &lt;54 mg/dl will be calculated</description>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values within the 70-140 mg/dl range that meet %30/30 accuracy criteria.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values within the 70-140 mg/dl range that meet %30/30 accuracy criteria.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values within the 140-180 mg/dl range that meet %30/30 accuracy criteria.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values within the 140-180 mg/dl range that meet %30/30 accuracy criteria.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values &gt; 180 mg/dl, Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values in the hyperglycemic range (&gt;180 mg/dl) that meet %30/30 accuracy criteria.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values &gt; 180 mg/dl, Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values in the hyperglycemic range (&gt;180 mg/dl) that meet %30/30 accuracy criteria.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Glycemic Variability Calculated by Standard Deviation by CGM Reading</title>
        <description>Glycemic variability will be calculated using Standard Deviation</description>
        <time_frame>10 days post discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Glycemic Variability Calculated by Standard Deviation by CGM Reading</title>
          <description>Glycemic variability will be calculated using Standard Deviation</description>
          <units>mg/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.37" spread="18.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.87" spread="20.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values &lt; 70 mg/dl Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values in the hypoglycemic range (&lt;70 mg/dl) that meet %20/20 accuracy criteria.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values &lt; 70 mg/dl Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values in the hypoglycemic range (&lt;70 mg/dl) that meet %20/20 accuracy criteria.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values within the 70-140 mg/dl range that meet %20/20 accuracy criteria.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values within the 70-140 mg/dl range that meet %20/20 accuracy criteria.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values &gt; 180 mg/dl, Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values in the hyperglycemic range (&gt;180 mg/dl) that meet %20/20 accuracy criteria..</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values &gt; 180 mg/dl, Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values in the hyperglycemic range (&gt;180 mg/dl) that meet %20/20 accuracy criteria..</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values within the 140-180 mg/dl range that meet %20/20 accuracy criteria.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values within the 140-180 mg/dl range that meet %20/20 accuracy criteria.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values &lt; 70 mg/dl Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values in the hypoglycemic range (&lt;70 mg/dl) that meet %15/15 accuracy criteria..</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values &lt; 70 mg/dl Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values in the hypoglycemic range (&lt;70 mg/dl) that meet %15/15 accuracy criteria..</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values within the 70-140 mg/dl range that meet %15/15 accuracy criteria.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values within the 70-140 mg/dl range that meet %15/15 accuracy criteria.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values within the 140-180 mg/dl range that meet %15/15 accuracy criteria.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values within the 140-180 mg/dl range that meet %15/15 accuracy criteria.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values &gt; 180 mg/dl, Compared to the Standard-of-care POC BG</title>
        <description>Percentage of CGM glucose values in the hyperglycemic range (&gt;180 mg/dl) that meet %15/15 accuracy criteria.</description>
        <time_frame>During hospital stay (3 days - up to 30 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
            <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.&#xD;
POC BG - Point-of-Care Blood Glucose monitoring: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values &gt; 180 mg/dl, Compared to the Standard-of-care POC BG</title>
          <description>Percentage of CGM glucose values in the hyperglycemic range (&gt;180 mg/dl) that meet %15/15 accuracy criteria.</description>
          <units>percentage of values</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CGM abdomen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CGM arm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 month</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Dexcom G6 CGM - Continues Glucose Monitoring Sensor System</title>
          <description>Dexcom G6 CGM - Continues Glucose Monitoring sensor system: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Sensor site irritation/bleeding</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Umpierrez</name_or_title>
      <organization>Emory University</organization>
      <phone>404-778-1665</phone>
      <email>geumpie@emory.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03832907
org study id: IRB00107627
nct id: NCT03832907
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This is an exploratory prospective study primary aiming to evaluate differences between
      Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose
      Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2)
      identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2
      diabetes treated with basal bolus insulin regimen.
Several studies have shown that the use of a device that can measure blood glucose levels
      every 5 minutes is more effective in identifying low blood glucose (hypoglycemia) and high
      blood glucose (hyperglycemia) when compared to regular measurements with fingersticks [point
      of care (POC)].

      This is an exploratory prospective study primary aiming to evaluate differences between
      Point-of-care (POC) testing (standard of care) and Dexcom G6 CGM (Continues Glucose
      Monitoring sensor system) in 1) glycemic control measured by mean daily blood glucose and 2)
      identifying hypoglycemic and hyperglycemic events - in patients with type 1 and type 2
      diabetes treated with basal bolus insulin regimen.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Mean Daily Blood Glucose by POC Reading сompared to CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Mean daily blood glucose will be calculated
measure: Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Number of clinical significant hypoglycemia (<54 mg/dl) events will be calculated
measure: Number of Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Number of severe hyperglycemia (>240 mg/dl) events will be recorded
measure: Mean Daily Blood Glucose by POC Reading Compared to CGM Reading
time frame: 10 days post discharge
description: Mean daily blood glucose will be calculated
measure: Number of Clinical Significant Hypoglycemia (<54 mg/dl) Events by POC Reading Compared to CGM Reading
time frame: 10 days post discharge
description: Number of clinical significant hypoglycemia (<54 mg/dl) events will be calculated
measure: Number of Clinical Significant Severe Hyperglycemia (>240 mg/dl) Events by POC Reading Compared to CGM Reading
time frame: 10 days post discharge
description: Number of severe hyperglycemia (>240 mg/dl) events will be recorded
measure: Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Number of nocturnal hypoglycemic events < 70 mg/dl (between 22:00 and 06:00) will be recorded
measure: Number of Nocturnal Hypoglycemic Events < 70 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
time frame: 10 days post discharge
description: Number of nocturnal hypoglycemic events < 70 mg/dl(between 22:00 and 06:00) will be recorded
measure: Number of of Hypoglycemic Events < 70mg/dl in POC Group by POC Reading Compared to CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Number of of hypoglycemic events < 70mg/dl will be recorded
measure: Number of Hypoglycemic Events < 70mg/dl by POC Reading Compared to CGM Reading
time frame: 10 days post discharge
description: Number of of hypoglycemic events < 70mg/dl will be recorded
measure: Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .
measure: Time in Hypoglycemia (Minutes) During the Day and Night by CGM Reading
time frame: 10 days post discharge
description: Time in hypoglycemia (minutes) during the day and night will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .
measure: Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Time in hyperglycemia (minutes) during the day and night> 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range. .
measure: Time in Hyperglycemia (Minutes) During the Day and Night> 240 mg/dl by CGM Reading
time frame: 10 days post discharge
description: Time in hyperglycemia (minutes) during the day and night> 240 mg/dl will be recorded. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.
measure: Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Number of hyperglycemic events > 240 mg/dl will be recorded
measure: Number of Hyperglycemic Events > 240 mg/dl by POC Reading Compared to CGM Reading
time frame: 10 days post discharge
description: Number of hyperglycemic events > 240 mg/dl will be recorded
measure: Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated
measure: Percentage of BG Readings Within Target BG of 70 and 180 mg/dl by POC Reading Compared to CGM Reading
time frame: 10 days post discharge
description: Percentage of BG readings within target BG of 70 and 180 mg/dl will be calculated
measure: Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70mg/dl by CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of patients with greater than 5%-time below glucose target <70mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.
measure: Percentage of Patients With Greater Than 5%-Time Below Glucose Target <70 mg/dl by CGM Reading
time frame: 10 days post discharge
description: Percentage of patients with greater than 5%-time below glucose target <70 mg/dl will be calculated
measure: Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180mg/dl by CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of patients with greater than 5%-time above glucose target >180 mg/dl will be calculated
measure: Percentage of Patients With Greater Than 5%-Time Above Glucose Target >180 mg/dl by CGM Reading
time frame: 10 days post discharge
description: Percentage of patients with greater than 5%-time above glucose target >180 will be calculated
measure: Glycemic Variability Calculated by Standard Deviation by CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Glycemic variability will be calculated using Standard Deviation
measure: Glycemic Variability Calculated by MAGE by CGM Reading
time frame: 10 days post discharge
description: MAGE: average amplitude of glycemic excursions with values exceeding a certain threshold.
measure: Number of Sensor Removal/Failures/Dislodgments
time frame: During hospital stay (3 days - up to 30 days)
description: Number of sensor removal/failures/dislodgments will be recorded
measure: Mean Absolute Relative Difference (MARD) of CGM Compared to POC
time frame: During hospital stay (3 days - up to 30 days)
description: Accuracy of Dexcom G6 CGM, as defined by overall MARD, compared to POC
measure: Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values < 70 mg/d Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) meeting %30/30 accuracy criteria.
measure: Percentage of Values Within Zone A, B, C, D of the Clarke Error Grid Measured in Abdomen
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.
measure: Percentage of Values Within Zone A, B, C of the Clarke Error Grid Measured in Arm
time frame: During hospital stay (3 days - up to 30 days) measured in arm
description: Percentage of CGM glucose values within defined performance zones (A-E) indicating potential for clinical error. The Clarke error grid analysis uses a Cartesian diagram, in which the estimated/predicted values are displayed on the y-axis, whereas the reference values are presented on the x-axis. This diagram is subdivided into 5 zones: A, B, C, D, and E. The points that fall within zones A and B represent, respectively, sufficiently accurate and acceptable glucose results (better outcome), points in zone C may prompt unnecessary corrections, points in zones D and E represent erroneous and incorrect treatment.
measure: Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Number of nocturnal hypoglycemic events < 54 mg/dl (between 22:00 and 06:00) will be recorded
measure: Number of Nocturnal Hypoglycemic Events < 54 mg/dl (Between 22:00 and 06:00) by POC Reading Compared to CGM Reading
time frame: 10 days post discharge
description: Number of nocturnal hypoglycemic events < 54 mg/dl(between 22:00 and 06:00) will be recorded
measure: Number of of Hypoglycemic Events < 54 in POC Group by POC Reading Compared to CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Number of of hypoglycemic events < 54 will be recorded
measure: Number of Hypoglycemic Events < 54mg/dl by POC Reading Compared to CGM Reading
time frame: 10 days post discharge
description: Number of of hypoglycemic events < 54mg/dl will be recorded
measure: Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54mg/dl by CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of patients with greater than 5%-time below glucose target <54mg/dl will be calculated. Only measured by CGM, Discrete POC values are not used to assess amount of time spent within a specific glucose range.
measure: Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading
time frame: 10 days post discharge
description: Percentage of patients with greater than 5%-time above glucose target >240 will be calculated
measure: Percentage of Patients With Greater Than 5%-Time Above Glucose Target >240 mg/dl by CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of patients with greater than 5%-time above glucose target >240 mg/dl will be calculated
measure: Glycemic Variability Calculated by MAGE by CGM Reading
time frame: During hospital stay (3 days - up to 30 days)
description: The average amplitude of glycemic excursions with values exceeding a certain threshold.
measure: Percentage of Patients With Greater Than 5%-Time Below Glucose Target <54 mg/dl by CGM Reading
time frame: 10 days post discharge
description: Percentage of patients with greater than 5%-time below glucose target <54 mg/dl will be calculated
measure: Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values within the 70-140 mg/dl range that meet %30/30 accuracy criteria.
measure: Percentage of Dexcom G6 CGM Sensor Values Within 30/30% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values within the 140-180 mg/dl range that meet %30/30 accuracy criteria.
measure: Percentage of Dexcom G6 CGM Sensor Values Within 30/30%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %30/30 accuracy criteria.
measure: Glycemic Variability Calculated by Standard Deviation by CGM Reading
time frame: 10 days post discharge
description: Glycemic variability will be calculated using Standard Deviation
measure: Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values < 70 mg/dl Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) that meet %20/20 accuracy criteria.
measure: Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values within the 70-140 mg/dl range that meet %20/20 accuracy criteria.
measure: Percentage of Dexcom G6 CGM Sensor Values Within 20/20%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %20/20 accuracy criteria..
measure: Percentage of Dexcom G6 CGM Sensor Values Within 20/20% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values within the 140-180 mg/dl range that meet %20/20 accuracy criteria.
measure: Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values < 70 mg/dl Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values in the hypoglycemic range (<70 mg/dl) that meet %15/15 accuracy criteria..
measure: Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 70-140 mg/dl Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values within the 70-140 mg/dl range that meet %15/15 accuracy criteria.
measure: Percentage of Dexcom G6 CGM Sensor Values Within 15/15% for Values 140-180 mg/dl , Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values within the 140-180 mg/dl range that meet %15/15 accuracy criteria.
measure: Percentage of Dexcom G6 CGM Sensor Values Within 15/15%for Values > 180 mg/dl, Compared to the Standard-of-care POC BG
time frame: During hospital stay (3 days - up to 30 days)
description: Percentage of CGM glucose values in the hyperglycemic range (>180 mg/dl) that meet %15/15 accuracy criteria.
arm group label: Dexcom G6 CGM - Continues Glucose Monitoring sensor system
arm group type: Experimental
description: The Dexcom G6 CGM is a commercially available factory-calibrated sensor system. The system measures interstitial glucose every 5-15 minutes, providing real-time and more complete glycemic profile during 24-hours compared to standard POC glucose testing, and replaces the need for finger sticking. Potential limitations include the need for removing the sensor before MRI or diathermy treatment, and the potential interference in patients with severe dehydration.
In parallel, same participants will be monitored by the standard of care point-of-care (POC) capillary glucose tests. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital.
intervention type: Device
intervention name: Dexcom G6 CGM - Continues Glucose Monitoring sensor system
description: A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.
arm group label: Dexcom G6 CGM - Continues Glucose Monitoring sensor system
intervention type: Diagnostic Test
intervention name: POC BG - Point-of-Care Blood Glucose monitoring
description: Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
arm group label: Dexcom G6 CGM - Continues Glucose Monitoring sensor system
other name: Standard of Care capillary glucose test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillermo Umpierrez, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Guillermo Umpierrez, MD
investigator title: Professor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 