<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/NCT01702311</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00056041</org_study_id>
    <nct_id>NCT01702311</nct_id>
  </id_info>
  <brief_title>Point-of-Care Glucose Testing and Insulin Supplementation</brief_title>
  <acronym>POC</acronym>
  <official_title>Benefits of Point-of-Care Glucose Testing and Insulin Supplementation at Bedtime in Insulin Treated Patients With Type 2 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Capillary point-of-care (POC) testing is advocated as a valuable aid in the management of&#xD;
      diabetes and hyperglycemia in the hospital setting. POC testing aims at collecting&#xD;
      information on BG levels at different time points during the day in order to assess glycemic&#xD;
      control and to guide insulin adjustment/correction doses. Although POC testing provides&#xD;
      insights into day-to-day excursions in BG levels, bedtime BG testing triggers the use of&#xD;
      insulin supplements that may result in increased frequency of hypoglycemia and is expensive&#xD;
      with an estimated annual cost in hospitals of several hundreds of millions of dollars in the&#xD;
      U.S. Accordingly, this pilot study aims to assess the utility of POC and insulin&#xD;
      supplementation (correction doses) at bedtime in improving glycemic control and in preventing&#xD;
      hypoglycemia in non-ICU patients with type 2 diabetes mellitus (T2DM). A total of 250 non-ICU&#xD;
      medical and surgical patients treated with basal bolus regimen will undergo POC testing&#xD;
      before meals and bedtime (standard of care) and half of the patients will receive insulin&#xD;
      correction doses at bedtime for BG &gt; 140 mg/dL following a sliding scale protocol, while the&#xD;
      other half will be followed without insulin supplementation at bedtime except for extreme&#xD;
      hyperglycemia (BG &gt; 350 mg/dl). Patients will be recruited at Emory University Hospital and&#xD;
      Grady Memorial Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The value of POC testing and use of insulin supplements (correction doses) in particular at&#xD;
      bedtime, has not been prospectively evaluated in insulin-treated patients with T2DM. In the&#xD;
      non-ICU setting, practice guidelines for the management of hyperglycemia in patients with&#xD;
      T2DM favor the use of physiologic (basal-nutritional-correction dose) insulin regimens over&#xD;
      sliding scale regular insulin. POC testing is invasive and painful, and has the limitation of&#xD;
      providing glycemic profile that is an incomplete picture of BG excursions and is not always&#xD;
      an accurate method to monitor glucose compared to laboratory assays in addition to the major&#xD;
      expense in health care delivery. The overall objective of this proposal is to conduct the&#xD;
      first prospective randomized controlled trial (RCT) to determine the POC glucose testing and&#xD;
      use of insulin supplementation at bedtime in improving glycemic control and in preventing&#xD;
      hypoglycemia in insulin-treated non-ICU patients with T2DM. The central hypothesis of this&#xD;
      proposal is that routine BG measurement and insulin supplementation at bedtime does not&#xD;
      improve glycemic control or reduce frequency of hypoglycemia in insulin treated medicine and&#xD;
      surgery patients with T2DM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Fasting Blood Glucose</measure>
    <time_frame>up to 10 days</time_frame>
    <description>The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Daily BG</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
    <description>Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hypoglycemia (BG &lt; 70 mg/dl)</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
    <description>Secondary outcomes include the number of hypoglycemia (BG &lt; 70 mg/dl) among both the groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Daily Dose of Insulin</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
    <description>Compare the daily dose of insulin used among both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of Hospital Stay</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
    <description>Length of hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Mortality</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
    <description>Mortality is defined as death occurring during admission or during the hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nosocomial Infections (CDC)</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
    <description>Nosocomial infections during hospital stay as per the CDC criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pneumonia</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
    <description>Pneumonia (CDC criteria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bacteremia</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
    <description>Bacteremia with SIRS/Sepsis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days</measure>
    <time_frame>daily while in hospital for up to 10 days</time_frame>
    <description>Respiratory failure, defined as PaO2 value &lt; 60 mm Hg while breathing air or a PaCO2 &gt; 50 mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Renal Failure [Rise &gt;50% of Baseline or Creatinine &gt;2.5 mg/dl]</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
    <description>Acute renal failure [rise &gt;50% of baseline or creatinine &gt;2.5 mg/dl]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of BG Within Target</measure>
    <time_frame>Participants will be followed over the hospital stay- expected 6 days.</time_frame>
    <description>Number of glucose levels within target of 70-140 mg/dl</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With BG &gt; 300 mg/dL</measure>
    <time_frame>Subjects will be followed over the hospital stay: expected 6 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">235</enrollment>
  <condition>Diabetes</condition>
  <arm_group>
    <arm_group_label>Bedtime supplementation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no bedtime supplementation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bedtime insulin Aspart (Novolog)</intervention_name>
    <description>Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
    <arm_group_label>Bedtime supplementation</arm_group_label>
    <other_name>Aspart (Novolog)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients with a known history of T2DM for &gt; 3 months&#xD;
&#xD;
          2. Age 18-80 years&#xD;
&#xD;
          3. Home treatment with either diet alone, any combination of oral antidiabetic agents,&#xD;
             non-insulin injectables or insulin therapy&#xD;
&#xD;
          4. BG &gt; 140 mg and &lt; 400 mg/dL without laboratory evidence of diabetic ketoacidosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hyperglycemia without a history of diabetes&#xD;
&#xD;
          2. Acute critical illness admitted to the ICU or expected to require ICU admission&#xD;
&#xD;
          3. Receiving continuous insulin infusion&#xD;
&#xD;
          4. Clinically relevant hepatic disease&#xD;
&#xD;
          5. Patients on corticosteroid therapy&#xD;
&#xD;
          6. Patients with creatinine ≥ 3.5 mg/dl&#xD;
&#xD;
          7. Subjects unable to sign consent&#xD;
&#xD;
          8. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillermo E Umpierrez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grady Memorial Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>May 8, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <results_first_submitted>July 2, 2014</results_first_submitted>
  <results_first_submitted_qc>July 2, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 1, 2014</results_first_posted>
  <last_update_submitted>December 5, 2017</last_update_submitted>
  <last_update_submitted_qc>December 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Guillermo Umpierrez</investigator_full_name>
    <investigator_title>Prinicipal Investigator</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <keyword>Point of care testing</keyword>
  <keyword>Hypoglycemia</keyword>
  <keyword>Basal bolus insulin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin Aspart</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>General medicine and surgery patients admitted to Emory University and Grady Hospital between May 2012 and December 2013</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Bedtime Supplementation</title>
          <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
        </group>
        <group group_id="P2">
          <title>No Bedtime Supplementation</title>
          <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="122"/>
                <participants group_id="P2" count="113"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Discharge less than 24 hours</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>16 subjects were not included in the data analysis for bedtime supplementation arm 13 subjects were not included in the data analysis for no bedtime supplementation arm</population>
      <group_list>
        <group group_id="B1">
          <title>Bedtime Supplementation</title>
          <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
        </group>
        <group group_id="B2">
          <title>No Bedtime Supplementation</title>
          <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</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="106"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="206"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58" spread="10"/>
                    <measurement group_id="B2" value="57" spread="11"/>
                    <measurement group_id="B3" value="57" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="159"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Fasting Blood Glucose</title>
        <description>The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.</description>
        <time_frame>up to 10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>No Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Fasting Blood Glucose</title>
          <description>The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.</description>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162" spread="44"/>
                    <measurement group_id="O2" value="157" spread="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Daily BG</title>
        <description>Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>no Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Daily BG</title>
          <description>Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG</description>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" spread="1.7"/>
                    <measurement group_id="O2" value="8.7" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hypoglycemia (BG &lt; 70 mg/dl)</title>
        <description>Secondary outcomes include the number of hypoglycemia (BG &lt; 70 mg/dl) among both the groups.</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>no Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hypoglycemia (BG &lt; 70 mg/dl)</title>
          <description>Secondary outcomes include the number of hypoglycemia (BG &lt; 70 mg/dl) among both the groups.</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Daily Dose of Insulin</title>
        <description>Compare the daily dose of insulin used among both groups</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>No Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Daily Dose of Insulin</title>
          <description>Compare the daily dose of insulin used among both groups</description>
          <units>units/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" spread="23"/>
                    <measurement group_id="O2" value="44" spread="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Length of Hospital Stay</title>
        <description>Length of hospitalization</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>No Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Hospital Stay</title>
          <description>Length of hospitalization</description>
          <units>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="106"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="4" upper_limit="13"/>
                    <measurement group_id="O2" value="6" lower_limit="5" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Mortality</title>
        <description>Mortality is defined as death occurring during admission or during the hospital stay</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>No Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Mortality</title>
          <description>Mortality is defined as death occurring during admission or during the hospital stay</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="100"/>
              </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>Nosocomial Infections (CDC)</title>
        <description>Nosocomial infections during hospital stay as per the CDC criteria</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>No Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Nosocomial Infections (CDC)</title>
          <description>Nosocomial infections during hospital stay as per the CDC criteria</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="100"/>
              </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>Pneumonia</title>
        <description>Pneumonia (CDC criteria)</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>No Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Pneumonia</title>
          <description>Pneumonia (CDC criteria)</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bacteremia</title>
        <description>Bacteremia with SIRS/Sepsis</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>No Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Bacteremia</title>
          <description>Bacteremia with SIRS/Sepsis</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="100"/>
              </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>Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days</title>
        <description>Respiratory failure, defined as PaO2 value &lt; 60 mm Hg while breathing air or a PaCO2 &gt; 50 mm Hg</description>
        <time_frame>daily while in hospital for up to 10 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>No Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days</title>
          <description>Respiratory failure, defined as PaO2 value &lt; 60 mm Hg while breathing air or a PaCO2 &gt; 50 mm Hg</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Renal Failure [Rise &gt;50% of Baseline or Creatinine &gt;2.5 mg/dl]</title>
        <description>Acute renal failure [rise &gt;50% of baseline or creatinine &gt;2.5 mg/dl]</description>
        <time_frame>participants will be followed for the duration of hospital stay, an expected average of 6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>No Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Renal Failure [Rise &gt;50% of Baseline or Creatinine &gt;2.5 mg/dl]</title>
          <description>Acute renal failure [rise &gt;50% of baseline or creatinine &gt;2.5 mg/dl]</description>
          <units>number of events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of BG Within Target</title>
        <description>Number of glucose levels within target of 70-140 mg/dl</description>
        <time_frame>Participants will be followed over the hospital stay- expected 6 days.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
          <group group_id="O2">
            <title>No Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of BG Within Target</title>
          <description>Number of glucose levels within target of 70-140 mg/dl</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With BG &gt; 300 mg/dL</title>
        <time_frame>Subjects will be followed over the hospital stay: expected 6 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>no Bedtime Supplementation</title>
            <description>Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
          </group>
          <group group_id="O2">
            <title>Bedtime Supplementation</title>
            <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With BG &gt; 300 mg/dL</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Bedtime Supplementation</title>
          <description>Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.&#xD;
Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.</description>
        </group>
        <group group_id="E2">
          <title>No Bedtime Supplementation</title>
          <description>Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </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="32" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemic events</sub_title>
                <description>blood glucose less than 70 mg/dL</description>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="100"/>
              </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>Guillermo Umpierrez, MD</name_or_title>
      <organization>Emory University</organization>
      <phone>404-778-1663</phone>
      <email>geumpie@emory.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702311
org study id: IRB00056041
nct id: NCT01702311
lead sponsor: 
has dmc: Yes
Capillary point-of-care (POC) testing is advocated as a valuable aid in the management of
      diabetes and hyperglycemia in the hospital setting. POC testing aims at collecting
      information on BG levels at different time points during the day in order to assess glycemic
      control and to guide insulin adjustment/correction doses. Although POC testing provides
      insights into day-to-day excursions in BG levels, bedtime BG testing triggers the use of
      insulin supplements that may result in increased frequency of hypoglycemia and is expensive
      with an estimated annual cost in hospitals of several hundreds of millions of dollars in the
      U.S. Accordingly, this pilot study aims to assess the utility of POC and insulin
      supplementation (correction doses) at bedtime in improving glycemic control and in preventing
      hypoglycemia in non-ICU patients with type 2 diabetes mellitus (T2DM). A total of 250 non-ICU
      medical and surgical patients treated with basal bolus regimen will undergo POC testing
      before meals and bedtime (standard of care) and half of the patients will receive insulin
      correction doses at bedtime for BG > 140 mg/dL following a sliding scale protocol, while the
      other half will be followed without insulin supplementation at bedtime except for extreme
      hyperglycemia (BG > 350 mg/dl). Patients will be recruited at Emory University Hospital and
      Grady Memorial Hospital.
The value of POC testing and use of insulin supplements (correction doses) in particular at
      bedtime, has not been prospectively evaluated in insulin-treated patients with T2DM. In the
      non-ICU setting, practice guidelines for the management of hyperglycemia in patients with
      T2DM favor the use of physiologic (basal-nutritional-correction dose) insulin regimens over
      sliding scale regular insulin. POC testing is invasive and painful, and has the limitation of
      providing glycemic profile that is an incomplete picture of BG excursions and is not always
      an accurate method to monitor glucose compared to laboratory assays in addition to the major
      expense in health care delivery. The overall objective of this proposal is to conduct the
      first prospective randomized controlled trial (RCT) to determine the POC glucose testing and
      use of insulin supplementation at bedtime in improving glycemic control and in preventing
      hypoglycemia in insulin-treated non-ICU patients with T2DM. The central hypothesis of this
      proposal is that routine BG measurement and insulin supplementation at bedtime does not
      improve glycemic control or reduce frequency of hypoglycemia in insulin treated medicine and
      surgery patients with T2DM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Fasting Blood Glucose
time frame: up to 10 days
description: The primary outcome of the study is to compare differences in mean fasting blood glucose levels between patients receiving insulin supplements at bedtime compared to those without insulin supplementation.
measure: Mean Daily BG
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
description: Secondary outcomes include differences between treatment groups in any of the following measures: mean daily BG
measure: Number of Hypoglycemia (BG < 70 mg/dl)
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
description: Secondary outcomes include the number of hypoglycemia (BG < 70 mg/dl) among both the groups.
measure: Daily Dose of Insulin
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
description: Compare the daily dose of insulin used among both groups
measure: Length of Hospital Stay
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
description: Length of hospitalization
measure: Hospital Mortality
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
description: Mortality is defined as death occurring during admission or during the hospital stay
measure: Nosocomial Infections (CDC)
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
description: Nosocomial infections during hospital stay as per the CDC criteria
measure: Pneumonia
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
description: Pneumonia (CDC criteria)
measure: Bacteremia
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
description: Bacteremia with SIRS/Sepsis
measure: Participants Will be Followed for the Duration of Hospital Stay, an Expected Average of 6 Days
time frame: daily while in hospital for up to 10 days
description: Respiratory failure, defined as PaO2 value < 60 mm Hg while breathing air or a PaCO2 > 50 mm Hg
measure: Acute Renal Failure [Rise >50% of Baseline or Creatinine >2.5 mg/dl]
time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
description: Acute renal failure [rise >50% of baseline or creatinine >2.5 mg/dl]
measure: Number of BG Within Target
time frame: Participants will be followed over the hospital stay- expected 6 days.
description: Number of glucose levels within target of 70-140 mg/dl
measure: Number of Subjects With BG > 300 mg/dL
time frame: Subjects will be followed over the hospital stay: expected 6 days
arm group label: Bedtime supplementation
arm group type: Active Comparator
description: Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.
arm group label: no bedtime supplementation
arm group type: No Intervention
description: Patients in this arm will have ac (before meals), qhs (at bedtime) and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
intervention type: Drug
intervention name: Bedtime insulin Aspart (Novolog)
description: Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.
arm group label: Bedtime supplementation
other name: Aspart (Novolog)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Guillermo E Umpierrez, MD
role: Principal Investigator
affiliation: Emory University
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Guillermo Umpierrez
investigator title: Prinicipal Investigator
mesh term: Diabetes Mellitus
mesh term: Insulin Aspart
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 