<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/NCT02258373</url>
  </required_header>
  <id_info>
    <org_study_id>T1DX-REPLACE-BG</org_study_id>
    <nct_id>NCT02258373</nct_id>
  </id_info>
  <brief_title>A Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes</brief_title>
  <acronym>REPLACE-BG</acronym>
  <official_title>A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaeb Center for Health Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jaeb Center for Health Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study is to determine whether the routine use of Continuous&#xD;
      Glucose Monitoring (CGM) without Blood Glucose Monitoring (BGM) confirmation is as safe and&#xD;
      effective as CGM used as an adjunct to BGM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CGM offers the opportunity to improve glycemic control, including a reduction in&#xD;
      hypoglycemia. Unlike home blood glucose monitors, CGM is not intended to be used directly for&#xD;
      making therapy adjustments and is an adjunctive device to supplement information obtained&#xD;
      from a standard blood glucose monitor. However, although the labeling for CGM requires a BGM&#xD;
      measurement before making a therapy adjustment, many CGM users often decide on a meal bolus&#xD;
      based on CGM alone.&#xD;
&#xD;
      A study comparing CGM used solely as an adjunctive device, as per the FDA labeling, versus&#xD;
      CGM used largely in lieu of BGM measurements would provide valuable data. Since many&#xD;
      individuals with T1D are often using CGM alone when bolusing insulin, obtaining data on the&#xD;
      safety and efficacy of this approach will be important. If indeed insulin dosing decisions&#xD;
      are proven to be safe and effective using CGM alone (without BGM confirmation) compared to&#xD;
      CGM with BGM confirmations, this study would also pave the way for a new standard diabetes&#xD;
      management protocol and therapy that would not require eight BGM measurements (i.e. finger&#xD;
      sticks) a day and ease the burden of managing type 1 diabetes.&#xD;
&#xD;
      For this study, participants will be randomly assigned with 2:1 probability to the CGM Only&#xD;
      and CGM+BGM groups, respectively. Prior to randomization, the study will be preceded by a&#xD;
      run-in period of up to 10 weeks to collect blinded baseline CGM data, to train the&#xD;
      participants on CGM use, to assess compliance with CGM use, and to initiate standard CGM use.&#xD;
      During the standard CGM use run-in phase, visits will occur after 2, 4 and 8 weeks, with&#xD;
      phone calls at 1, 3, and 6 weeks. Current CGM users may be eligible to skip part of the&#xD;
      run-in phase. Participants successfully completing the run-in phase will be randomized.&#xD;
&#xD;
      Both groups will use CGM devices and BGM. The CGM device to be used in the study is the&#xD;
      Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm. The CGM+BGM&#xD;
      group will be instructed to measure the blood glucose whenever a diabetes management decision&#xD;
      is made. The CGM Only group will be instructed to only measure the blood glucose (other than&#xD;
      for calibration) with a standard BGM meter in certain circumstances and will use a blinded&#xD;
      BGM meter at times when a standard BGM measurement is not done. Following randomization,&#xD;
      there will be a phone contact during the first week (4 to 8 days following randomization) to&#xD;
      address any questions the participant has about the protocol. Follow up visits will occur at&#xD;
      3, 6, 13, 19 and 26 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Glucose</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measures of Glycemic Variability: Coefficient of Variation</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
    <description>Coefficient of variation = SD/mean</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time With Sensor Value &lt;70 mg/dl, Measured With CGM</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time With Sensor Values &lt;60 mg/dl, Measured With CGM</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time With Sensor Values &lt;50 mg/dl, Measured With CGM</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days With at Least 20 Minutes of Sensor Glucose Values &lt;60 mg/dl</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time With Sensor Values &gt;180 mg/dl, Measured With CGM</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time With Sensor Values &gt; 250 mg/dl, Measured With CGM</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Time With Sensor Values &gt; 300 mg/dl, Measured With CGM</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Days With at Least 20 Minutes of Sensor Glucose Values &gt;300 mg/dl</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HbA1c</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With no Worsening of HbA1c by Greater Than 0.3% AND no Severe Hypoglycemia Event</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With &gt;=1 Severe Hypoglycemia Events</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With &gt;=1 Diabetic Ketoacidosis (DKA) Events</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With &gt;=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level &gt;=0.6 mmol/L</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With &gt;=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level &gt;=1.0 mmol/L</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With &gt;=1 Serious Adverse Event Other Than SH</measure>
    <time_frame>Between baseline (randomization) and 6 months</time_frame>
    <description>A serious adverse event is any untoward occurrence that:&#xD;
Results in death.&#xD;
Is life-threatening; (a non-life-threatening event which, had it been more severe, might have become life-threatening, is not necessarily considered a serious adverse event).&#xD;
Requires inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions (sight threatening).&#xD;
Is a congenital anomaly or birth defect.&#xD;
Is considered a significant medical event by the investigator based on medical judgment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">226</enrollment>
  <condition>Type 1 Diabetes</condition>
  <arm_group>
    <arm_group_label>CGM Only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CGM+BGM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CGM+BGM</intervention_name>
    <description>Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
    <arm_group_label>CGM+BGM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CGM Only</intervention_name>
    <description>Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
    <arm_group_label>CGM Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        To be eligible, all participants must meet the following inclusion criteria:&#xD;
&#xD;
          1. Clinical diagnosis of type 1 diabetes (based on investigator's judgment)&#xD;
&#xD;
          2. Age &gt;=18 years&#xD;
&#xD;
          3. T1D duration &gt;=1&#xD;
&#xD;
          4. HbA1c &lt;=9.0% (a local laboratory or DCA2000 or comparable point of care device will be&#xD;
             used to assess eligibility)&#xD;
&#xD;
          5. Use of an insulin pump for insulin delivery for at least 3 months, with no plans to&#xD;
             discontinue pump use during the next 8 months&#xD;
&#xD;
          6. Participant is able to manage his/her diabetes with respect to insulin administration&#xD;
             and glucose monitoring, as assessed by the investigator during the screening visit&#xD;
&#xD;
          7. Participant understands the study protocol and agrees to comply with it, including&#xD;
             willingness to use the study CGM and BGM&#xD;
&#xD;
          8. No expectation that participant will be moving out of the area of the clinical center&#xD;
             during the time period of the study, unless the move will be to an area served by&#xD;
             another study center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individuals who meet any of the following criteria are not eligible for the study:&#xD;
&#xD;
          1. Severe hypoglycemia in the last 12 months in which the assistance of another&#xD;
             individual was needed or seizure/loss of consciousness in the past 3 years&#xD;
&#xD;
          2. Significant hypoglycemia unawareness based on the Clarke Hypoglycemia Unawareness&#xD;
             Survey defined as at least one of the following being present:&#xD;
&#xD;
               -  Survey score &gt;2&#xD;
&#xD;
               -  Survey Q1 is answered as 'I no longer have symptoms when my blood sugar is low'&#xD;
&#xD;
               -  Survey Q7 response indicates that symptoms of hypoglycemia are not felt until&#xD;
                  glucose level is &lt;50 mg/dl&#xD;
&#xD;
               -  Survey Q8 response is never or rarely to the question 'to what extent can you&#xD;
                  tell by your symptoms that your blood sugar is low'&#xD;
&#xD;
          3. More than one DKA event in the past year&#xD;
&#xD;
          4. History of seizures other than due to hypoglycemia&#xD;
&#xD;
          5. Current use of a threshold suspend pump feature (note: participant is eligible if a&#xD;
             pump with this feature was being used but the threshold suspend was not active)&#xD;
&#xD;
          6. Myocardial infarction or stroke in past 6 months&#xD;
&#xD;
          7. Estimated Glomerular Filtration Rate (GFR) &lt;30 obtained within the prior 12 months as&#xD;
             part of usual care or kidney transplant&#xD;
&#xD;
          8. Most recent thyroid function test results abnormal, obtained as part of usual care&#xD;
             within the prior 2 years&#xD;
&#xD;
          9. The presence of a significant medical or psychiatric disorder or use of a medication&#xD;
             that in the judgment of the investigator will affect the wearing of the sensors, the&#xD;
             completion of any aspect of the protocol, or increase risk&#xD;
&#xD;
         10. Cognitive difficulties that, in the judgment of the investigator, could impair the&#xD;
             individual's ability to follow the protocol or increase risk&#xD;
&#xD;
         11. Initiation of a non-insulin drug for glucose control during the past 3 months, planned&#xD;
             initiation during the next 8 months, or discontinuation of a non-insulin drug for&#xD;
             glucose control during the past 3 months (note: individuals using a non-insulin&#xD;
             medication for glucose control for 3 or more months are eligible provided there is no&#xD;
             expectation that the medication will be discontinued during the time period of study&#xD;
             participation)&#xD;
&#xD;
         12. Use of a systemic beta blocker drug&#xD;
&#xD;
         13. Regular use of oral corticosteroids&#xD;
&#xD;
         14. Anticipated need to use acetaminophen during the time course of the study&#xD;
&#xD;
         15. Inpatient psychiatric treatment in the past 6 months&#xD;
&#xD;
         16. Currently pregnant or lactating or plan to attempt getting pregnant during the time&#xD;
             period of the study&#xD;
&#xD;
             • Females with child-bearing potential will be queried about the possibility of&#xD;
             pregnancy and a urine pregnancy test will be performed if there is uncertainty as to&#xD;
             the possibility of pregnancy. They must agree to use appropriate birth control during&#xD;
             the time period of the study. Participants will receive education regarding birth&#xD;
             control methods which may be considered as highly effective, which are methods that&#xD;
             can achieve a failure rate less than 1% per year when used consistently and correctly&#xD;
             and include:&#xD;
&#xD;
               -  Combined hormonal contraception associated with inhibition of ovulation (oral,&#xD;
                  intravaginal, transdermal)&#xD;
&#xD;
               -  Progestogen-only hormonal contraception associated with inhibition of ovulation&#xD;
                  (oral, injectable, implantable)&#xD;
&#xD;
               -  Intrauterine device (IUD)&#xD;
&#xD;
               -  Intrauterine hormone-releasing system (IUS)&#xD;
&#xD;
               -  Bilateral tubal occlusion&#xD;
&#xD;
               -  Vasectomised partner&#xD;
&#xD;
               -  Sexual abstinence&#xD;
&#xD;
         17. Participation in an intervention study (including psychological studies) in past 6&#xD;
             weeks&#xD;
&#xD;
         18. Known adhesive allergy&#xD;
&#xD;
         19. From the blinded run-in phase (or from pre-study CGM use if criteria met to skip the&#xD;
             blinded run-in phase), CGM values &lt;60 mg/dl for more than 10.0% of the time&#xD;
&#xD;
         20. Unsuccessful completion of the run-in phases with respect to CGM or BGM use&#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>Katrina Ruedy, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jaeb Center for Health Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scripps Health</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Davis Center for Diabetes</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Florida</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlanta Diabetes</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30318</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Diabetes and Endocrinology Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joslin Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-5456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Diabetes Center-Park Nicollet</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104-5160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <results_first_submitted>March 6, 2018</results_first_submitted>
  <results_first_submitted_qc>August 8, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 9, 2018</results_first_posted>
  <last_update_submitted>August 8, 2018</last_update_submitted>
  <last_update_submitted_qc>August 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Diabetes Mellitus</keyword>
  <keyword>Continuous Glucose Monitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>CGM Only</title>
          <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
        </group>
        <group group_id="P2">
          <title>CGM+BGM</title>
          <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="149"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="142"/>
                <participants group_id="P2" count="75"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>CGM Only</title>
          <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
        </group>
        <group group_id="B2">
          <title>CGM+BGM</title>
          <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="149"/>
            <count group_id="B2" value="77"/>
            <count group_id="B3" value="226"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44" spread="14"/>
                    <measurement group_id="B2" value="45" spread="13"/>
                    <measurement group_id="B3" value="44" spread="14"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="139"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="207"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black/African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other/unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="149"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.7" spread="4.1"/>
                    <measurement group_id="B2" value="26.5" spread="4.9"/>
                    <measurement group_id="B3" value="27.3" spread="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diabetes Duration</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23" spread="12"/>
                    <measurement group_id="B2" value="25" spread="12"/>
                    <measurement group_id="B3" value="24" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Annual Household Income ($)</title>
          <population>Annual household income is missing for 38 in the CGM Only group and 20 in the CGM+BGM group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="111"/>
                    <count group_id="B2" value="57"/>
                    <count group_id="B3" value="168"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;50,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50,000-&lt;100,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=100,000</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest Education</title>
          <population>Education is missing for 1 in the CGM Only group and 4 in the CGM+BGM group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="148"/>
                    <count group_id="B2" value="73"/>
                    <count group_id="B3" value="221"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;Bachelor's Degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bachelor's Degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Post-Bachelor's Degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insurance</title>
          <population>Insurance is missing for 0 in the CGM Only group and 2 in the CGM+BGM group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="75"/>
                    <count group_id="B3" value="224"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Private</title>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="198"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CGM Use Before Study</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Never used CGM</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>In past, but not current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current Dexcom CGM user</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Current Medtronic CGM user</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Central Laboratory HbA1c Value</title>
          <description>The local laboratory HbA1c value was used for one participant in the CGM+BGM group whose central laboratory value was unavailable.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;7.0% (53 mmol/mol)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="98"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7.0%-&lt;8.0% (53-&lt;64 mmol/mol)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=8.0% (64 mmol/mol)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-reported BGM Testing</title>
          <units>tests/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5.2" spread="2.1"/>
                    <measurement group_id="B2" value="4.9" spread="1.9"/>
                    <measurement group_id="B3" value="5.1" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Clarke Hypoglycemia Unawareness Survey Total Score</title>
          <description>8 items related to hypoglycemia unawareness. Each item is scored differently. Range is 0 to 7. Total score ≥4 is reduced awareness, =3 is uncertain and ≤2 is aware.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="149"/>
                    <count group_id="B2" value="77"/>
                    <count group_id="B3" value="226"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM</title>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" spread="13"/>
                    <measurement group_id="O2" value="65" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Glucose</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Glucose</title>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <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="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162" spread="23"/>
                    <measurement group_id="O2" value="158" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measures of Glycemic Variability: Coefficient of Variation</title>
        <description>Coefficient of variation = SD/mean</description>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Measures of Glycemic Variability: Coefficient of Variation</title>
          <description>Coefficient of variation = SD/mean</description>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <units>percent</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" lower_limit="34" upper_limit="41"/>
                    <measurement group_id="O2" value="37" lower_limit="34" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time With Sensor Value &lt;70 mg/dl, Measured With CGM</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time With Sensor Value &lt;70 mg/dl, Measured With CGM</title>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1.6" upper_limit="5.1"/>
                    <measurement group_id="O2" value="3.7" lower_limit="1.9" upper_limit="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time With Sensor Values &lt;60 mg/dl, Measured With CGM</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time With Sensor Values &lt;60 mg/dl, Measured With CGM</title>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="0.5" upper_limit="2.4"/>
                    <measurement group_id="O2" value="1.6" lower_limit="0.6" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time With Sensor Values &lt;50 mg/dl, Measured With CGM</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time With Sensor Values &lt;50 mg/dl, Measured With CGM</title>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.2" upper_limit="0.8"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.2" upper_limit="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days With at Least 20 Minutes of Sensor Glucose Values &lt;60 mg/dl</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days With at Least 20 Minutes of Sensor Glucose Values &lt;60 mg/dl</title>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" lower_limit="13" upper_limit="42"/>
                    <measurement group_id="O2" value="32" lower_limit="16" upper_limit="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time With Sensor Values &gt;180 mg/dl, Measured With CGM</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time With Sensor Values &gt;180 mg/dl, Measured With CGM</title>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" lower_limit="25" upper_limit="41"/>
                    <measurement group_id="O2" value="31" lower_limit="24" upper_limit="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time With Sensor Values &gt; 250 mg/dl, Measured With CGM</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time With Sensor Values &gt; 250 mg/dl, Measured With CGM</title>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="5" upper_limit="13"/>
                    <measurement group_id="O2" value="7" lower_limit="4" upper_limit="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Time With Sensor Values &gt; 300 mg/dl, Measured With CGM</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time With Sensor Values &gt; 300 mg/dl, Measured With CGM</title>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <units>percentage of time</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Days With at Least 20 Minutes of Sensor Glucose Values &gt;300 mg/dl</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Days With at Least 20 Minutes of Sensor Glucose Values &gt;300 mg/dl</title>
          <population>One participant in the CGM Only group and one in the CGM+BGM group never came in for a follow-up visit and therefore had no CGM data.</population>
          <units>percentage of days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="148"/>
                <count group_id="O2" value="76"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" lower_limit="14" upper_limit="40"/>
                    <measurement group_id="O2" value="20" lower_limit="10" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in HbA1c</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>Missing followup HbA1c data for 7 in the CGM Only group and 2 in the CGM+BGM group.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Change in HbA1c</title>
          <population>Missing followup HbA1c data for 7 in the CGM Only group and 2 in the CGM+BGM group.</population>
          <units>mmol/mol</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="5.5"/>
                    <measurement group_id="O2" value="0.0" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With no Worsening of HbA1c by Greater Than 0.3% AND no Severe Hypoglycemia Event</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <population>Missing followup HbA1c data for 7 in the CGM Only group and 2 in the CGM+BGM group.</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With no Worsening of HbA1c by Greater Than 0.3% AND no Severe Hypoglycemia Event</title>
          <population>Missing followup HbA1c data for 7 in the CGM Only group and 2 in the CGM+BGM group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="75"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With &gt;=1 Severe Hypoglycemia Events</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With &gt;=1 Severe Hypoglycemia Events</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With &gt;=1 Diabetic Ketoacidosis (DKA) Events</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With &gt;=1 Diabetic Ketoacidosis (DKA) Events</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With &gt;=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level &gt;=0.6 mmol/L</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With &gt;=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level &gt;=0.6 mmol/L</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With &gt;=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level &gt;=1.0 mmol/L</title>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With &gt;=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level &gt;=1.0 mmol/L</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With &gt;=1 Serious Adverse Event Other Than SH</title>
        <description>A serious adverse event is any untoward occurrence that:&#xD;
Results in death.&#xD;
Is life-threatening; (a non-life-threatening event which, had it been more severe, might have become life-threatening, is not necessarily considered a serious adverse event).&#xD;
Requires inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions (sight threatening).&#xD;
Is a congenital anomaly or birth defect.&#xD;
Is considered a significant medical event by the investigator based on medical judgment.</description>
        <time_frame>Between baseline (randomization) and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>CGM Only</title>
            <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
          </group>
          <group group_id="O2">
            <title>CGM+BGM</title>
            <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With &gt;=1 Serious Adverse Event Other Than SH</title>
          <description>A serious adverse event is any untoward occurrence that:&#xD;
Results in death.&#xD;
Is life-threatening; (a non-life-threatening event which, had it been more severe, might have become life-threatening, is not necessarily considered a serious adverse event).&#xD;
Requires inpatient hospitalization or prolongation of existing hospitalization.&#xD;
Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions (sight threatening).&#xD;
Is a congenital anomaly or birth defect.&#xD;
Is considered a significant medical event by the investigator based on medical judgment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="149"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Between baseline (randomization) and 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>CGM Only</title>
          <description>Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.&#xD;
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.&#xD;
CGM Only: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm</description>
        </group>
        <group group_id="E2">
          <title>CGM+BGM</title>
          <description>Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.&#xD;
CGM+BGM: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="149"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Basedow's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycaemic seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Knee arthroplasty</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>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="6" subjects_at_risk="149"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Dermatitis psoriasiform</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="149"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="77"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="149"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="77"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Katrina Ruedy</name_or_title>
      <organization>Jaeb Center for Health Research</organization>
      <phone>8139758690</phone>
      <email>kruedy@jaeb.org</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/NCT02258373
org study id: T1DX-REPLACE-BG
nct id: NCT02258373
lead sponsor: 
has dmc: Yes
The primary objective of the study is to determine whether the routine use of Continuous
      Glucose Monitoring (CGM) without Blood Glucose Monitoring (BGM) confirmation is as safe and
      effective as CGM used as an adjunct to BGM.
CGM offers the opportunity to improve glycemic control, including a reduction in
      hypoglycemia. Unlike home blood glucose monitors, CGM is not intended to be used directly for
      making therapy adjustments and is an adjunctive device to supplement information obtained
      from a standard blood glucose monitor. However, although the labeling for CGM requires a BGM
      measurement before making a therapy adjustment, many CGM users often decide on a meal bolus
      based on CGM alone.

      A study comparing CGM used solely as an adjunctive device, as per the FDA labeling, versus
      CGM used largely in lieu of BGM measurements would provide valuable data. Since many
      individuals with T1D are often using CGM alone when bolusing insulin, obtaining data on the
      safety and efficacy of this approach will be important. If indeed insulin dosing decisions
      are proven to be safe and effective using CGM alone (without BGM confirmation) compared to
      CGM with BGM confirmations, this study would also pave the way for a new standard diabetes
      management protocol and therapy that would not require eight BGM measurements (i.e. finger
      sticks) a day and ease the burden of managing type 1 diabetes.

      For this study, participants will be randomly assigned with 2:1 probability to the CGM Only
      and CGM+BGM groups, respectively. Prior to randomization, the study will be preceded by a
      run-in period of up to 10 weeks to collect blinded baseline CGM data, to train the
      participants on CGM use, to assess compliance with CGM use, and to initiate standard CGM use.
      During the standard CGM use run-in phase, visits will occur after 2, 4 and 8 weeks, with
      phone calls at 1, 3, and 6 weeks. Current CGM users may be eligible to skip part of the
      run-in phase. Participants successfully completing the run-in phase will be randomized.

      Both groups will use CGM devices and BGM. The CGM device to be used in the study is the
      Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm. The CGM+BGM
      group will be instructed to measure the blood glucose whenever a diabetes management decision
      is made. The CGM Only group will be instructed to only measure the blood glucose (other than
      for calibration) with a standard BGM meter in certain circumstances and will use a blinded
      BGM meter at times when a standard BGM measurement is not done. Following randomization,
      there will be a phone contact during the first week (4 to 8 days following randomization) to
      address any questions the participant has about the protocol. Follow up visits will occur at
      3, 6, 13, 19 and 26 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Percentage of Time in Range of 70 to 180 mg/dl, Measured With CGM
time frame: Between baseline (randomization) and 6 months
measure: Mean Glucose
time frame: Between baseline (randomization) and 6 months
measure: Measures of Glycemic Variability: Coefficient of Variation
time frame: Between baseline (randomization) and 6 months
description: Coefficient of variation = SD/mean
measure: Percentage of Time With Sensor Value <70 mg/dl, Measured With CGM
time frame: Between baseline (randomization) and 6 months
measure: Percentage of Time With Sensor Values <60 mg/dl, Measured With CGM
time frame: Between baseline (randomization) and 6 months
measure: Percentage of Time With Sensor Values <50 mg/dl, Measured With CGM
time frame: Between baseline (randomization) and 6 months
measure: Percentage of Days With at Least 20 Minutes of Sensor Glucose Values <60 mg/dl
time frame: Between baseline (randomization) and 6 months
measure: Percentage of Time With Sensor Values >180 mg/dl, Measured With CGM
time frame: Between baseline (randomization) and 6 months
measure: Percentage of Time With Sensor Values > 250 mg/dl, Measured With CGM
time frame: Between baseline (randomization) and 6 months
measure: Percentage of Time With Sensor Values > 300 mg/dl, Measured With CGM
time frame: Between baseline (randomization) and 6 months
measure: Percentage of Days With at Least 20 Minutes of Sensor Glucose Values >300 mg/dl
time frame: Between baseline (randomization) and 6 months
measure: Change in HbA1c
time frame: Between baseline (randomization) and 6 months
measure: Number of Participants With no Worsening of HbA1c by Greater Than 0.3% AND no Severe Hypoglycemia Event
time frame: Between baseline (randomization) and 6 months
measure: Number of Participants With >=1 Severe Hypoglycemia Events
time frame: Between baseline (randomization) and 6 months
measure: Number of Participants With >=1 Diabetic Ketoacidosis (DKA) Events
time frame: Between baseline (randomization) and 6 months
measure: Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=0.6 mmol/L
time frame: Between baseline (randomization) and 6 months
measure: Number of Participants With >=1 Ketotic Events Not Meeting Criteria for DKA With Blood Ketone Level >=1.0 mmol/L
time frame: Between baseline (randomization) and 6 months
measure: Number of Participants With >=1 Serious Adverse Event Other Than SH
time frame: Between baseline (randomization) and 6 months
description: A serious adverse event is any untoward occurrence that:
Results in death.
Is life-threatening; (a non-life-threatening event which, had it been more severe, might have become life-threatening, is not necessarily considered a serious adverse event).
Requires inpatient hospitalization or prolongation of existing hospitalization.
Results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions (sight threatening).
Is a congenital anomaly or birth defect.
Is considered a significant medical event by the investigator based on medical judgment.
arm group label: CGM Only
arm group type: Experimental
description: Participants will be instructed to check the blood glucose with the standard study BGM for calibration of the CGM and for specific circumstances that are specified in the protocol. This group will make management decisions based on the CGM glucose value without a BGM confirmation measurement as long as the participant is confident that the CGM glucose value is not erroneous.
In addition, participants will be instructed to make a BGM measurement on the blinded study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia and a standard BGM measurement has not been made. The participant may be asked to make post-prandial blinded BGM measurements at selected times.
arm group label: CGM+BGM
arm group type: Active Comparator
description: Participants will be instructed to perform BGM measurements for sensor calibration according to Dexcom specifications and measure the blood glucose whenever a diabetes management decision is made. A BGM measurement is to be made on the study BGM before going to bed, whenever an insulin bolus is given and when treating or attempting to prevent hypoglycemia. Additional BGM measurements can be made on the study BGM at any time that the participant desires.
intervention type: Device
intervention name: CGM+BGM
description: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
arm group label: CGM+BGM
intervention type: Device
intervention name: CGM Only
description: Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm
arm group label: CGM Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katrina Ruedy, MSPH
role: Principal Investigator
affiliation: Jaeb Center for Health Research
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 