<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/NCT03805412</url>
  </required_header>
  <id_info>
    <org_study_id>180609</org_study_id>
    <nct_id>NCT03805412</nct_id>
  </id_info>
  <brief_title>Continuous Glucose Monitoring in Diabetes and Prediabetes</brief_title>
  <official_title>A Pilot Study on the Use of Real-Time Continuous Glucose Monitoring (RT-CGM) as an Educational Tool for Patients With Prediabetes and Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nicole Ehrhardt, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DexCom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>George Washington University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the use of brief serial real time continuous monitoring (RT-CGM) as a behavior&#xD;
      modification tool in obese patients with prediabetes and diabetes. After receiving RT-CGM,&#xD;
      nutrition and exercise education, participants will be able to monitor their blood sugar in&#xD;
      real time for 2 sessions . Education on how to interpret CGM in the setting of food choices&#xD;
      and exercise coupled with nutrition and exercise information should lead to improved weight&#xD;
      and other nutritional and exercise changes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">July 3, 2020</completion_date>
  <primary_completion_date type="Actual">July 3, 2020</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percent Change in BMI From Baseline to 14 Weeks</measure>
    <time_frame>14 weeks</time_frame>
    <description>weight and height will be combined to report % change BMI in kg/m^2 at 14 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent Body Fat Change at 14 Weeks</measure>
    <time_frame>14 weeks</time_frame>
    <description>Percent by Tanita scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes</measure>
    <time_frame>14 weeks</time_frame>
    <description>Experiences of CGM @Joslin 2009 scale of (5) strongly agree or (1) strongly disagree about statements/questions that measured the amount of satisfaction that was derived from continuous glucose monitoring. The larger the score the more satisfied participants were with CGM. 100 being the max score and 20 being the min score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Glucose Change at 14 Weeks</measure>
    <time_frame>14 weeks</time_frame>
    <description>average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food Frequency Change in Score at 14 Weeks</measure>
    <time_frame>14 weeks</time_frame>
    <description>Starting The Conversation (STC) is an eight-item simplified food frequency instrument/questionnaire a max score of 16 indicates poor food choices and a minimum score of 0 indicates good food choices. Results reported is change from baseline score with a negative score being a marker of improvement in food choices and a positive score being worsening of food choices</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Minutes Walked Per Week at 14 Weeks</measure>
    <time_frame>14 weeks</time_frame>
    <description>The International Physical Activity Questionnaire(short) is as validated questionnaire which asks the time in minutes or hours in last week you do vigorous exercise, moderate intensity exercise, walking and sitting</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MAGE Mean Amplitude of Glycemic Excursion</measure>
    <time_frame>14 weeks</time_frame>
    <description>this is calculation of variance of glucose for CGM</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Diabetes Mellitus, Type 2</condition>
  <condition>PreDiabetes</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>DEXCOM G6 RT-CGM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blinded CGM</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DEXCOM G6 RT-CGM</intervention_name>
    <description>CGM is a way to measure glucose levels in real-time. A tiny electrode called a glucose sensor is inserted under the skin to measure glucose levels in tissue fluid. A small plastic piece of tube remains inserted in the skin. It is connected to a transmitter that sits on top of the skin. It is approved for use on the abdomen for 10 days. It either records the sugars downloaded in the clinic (blinded part of the study) or it sends the information via wireless radio frequency to a monitoring/ display device or to a cellular phone so participants can see data. DEXCOM G6 is FDA approved for use in patients with diabetes and will be used in accordance with instructions as approved for diabetes.</description>
    <arm_group_label>DEXCOM G6 RT-CGM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-55&#xD;
&#xD;
          2. Prediabetes (A1c 6.0-6.4) or Diabetes (A1c 7.0-10)&#xD;
&#xD;
          3. BMI ≥ 30 kg/m2&#xD;
&#xD;
          4. Willing to wear pedometer during study period&#xD;
&#xD;
          5. Able to walk 2 city blocks at baseline without assistance (self-reported)&#xD;
&#xD;
          6. Reading level at least 6th grade in English&#xD;
&#xD;
          7. Expected to remain in local community for at least 4 months&#xD;
&#xD;
          8. Either is not treated with or has been on a stable treatment regimen of any of the&#xD;
             following medications for a minimum of 3 months prior to Visit 1&#xD;
             (Screening/Enrollment):&#xD;
&#xD;
               1. Sulfonylureas&#xD;
&#xD;
               2. Biguanidine&#xD;
&#xD;
               3. Thyroid replacement therapy&#xD;
&#xD;
               4. Glp-1 agonists&#xD;
&#xD;
               5. Sodium-glucose co-transporters&#xD;
&#xD;
               6. Basal insulin&#xD;
&#xD;
               7. Thiazolidinediones&#xD;
&#xD;
               8. Hormone replacement therapy (female subjects) estrogen/progesterone products&#xD;
&#xD;
               9. Oral contraceptives/birth control (female subjects)&#xD;
&#xD;
              10. Antidepressant agents (SSRIs, Paxil, Prozac, Celexa, Zoloft, etc.)&#xD;
&#xD;
          9. Is able to read, understand, and sign the Informed Consent Form (ICF) and if&#xD;
             applicable, an Authorization to Use and Disclose Protected Health Information form&#xD;
             (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA]&#xD;
             legislation), communicate with the investigator, and understand and comply with&#xD;
             protocol requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women who are pregnant, lactating, planning to become pregnant&#xD;
&#xD;
          2. Subjects who are taking amphetamines, anabolic, or weight-reducing agents&#xD;
&#xD;
          3. Contraindications to moderate exercise&#xD;
&#xD;
          4. Pre-prandial insulin&#xD;
&#xD;
          5. On any antipsychotic medication or history of schizophrenia or bipolar disorder&#xD;
&#xD;
          6. Daily use of any form of steroid medication (oral, inhaled, injected) within the last&#xD;
             3 months&#xD;
&#xD;
          7. Active wounds or recent surgery within 3 months&#xD;
&#xD;
          8. Inflammatory disease, or chronic and current use of anti-inflammatory drugs or&#xD;
             narcotics&#xD;
&#xD;
          9. Active cardiovascular diseases within 12 months of Visit 1, such as myocardial&#xD;
             infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass&#xD;
             surgery, or angioplasty; or are expected to require coronary artery bypass surgery or&#xD;
             angioplasty during the course of the study&#xD;
&#xD;
         10. Presence or history of severe congestive heart failure (New York Heart Association&#xD;
             Class IV [CCNYHA 1994])&#xD;
&#xD;
         11. Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the&#xD;
             investigator's opinion, would cause the individual to be noncompliant&#xD;
&#xD;
         12. Enrolled in another weight loss program&#xD;
&#xD;
         13. Already receiving continuous glucose monitoring (CGM)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole Ehrhardt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>George Washington University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GWU Medical Faculty Associates</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <results_first_submitted>September 10, 2021</results_first_submitted>
  <results_first_submitted_qc>February 1, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 1, 2023</results_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>George Washington University</investigator_affiliation>
    <investigator_full_name>Nicole Ehrhardt, MD</investigator_full_name>
    <investigator_title>Endocrinologist, Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Prediabetic State</mesh_term>
    <mesh_term>Glucose Intolerance</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03805412/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/12/NCT03805412/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>note study was closed early given covid so enrollement was 23 not 45 as in orginal protocol</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>DEXCOM G6 RT-CGM</title>
          <description>These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.</description>
        </group>
        <group group_id="P2">
          <title>Blinded CGM</title>
          <description>These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>DEXCOM G6 RT-CGM</title>
          <description>These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.</description>
        </group>
        <group group_id="B2">
          <title>Blinded CGM</title>
          <description>These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.</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="15"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Participants were between the ages of 18 and 55 years old</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="23"/>
                  </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="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percent Change in BMI From Baseline to 14 Weeks</title>
        <description>weight and height will be combined to report % change BMI in kg/m^2 at 14 weeks</description>
        <time_frame>14 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEXCOM G6 RT-CGM</title>
            <description>These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Blinded CGM</title>
            <description>These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in BMI From Baseline to 14 Weeks</title>
          <description>weight and height will be combined to report % change BMI in kg/m^2 at 14 weeks</description>
          <units>% change over 14 weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="0.5"/>
                    <measurement group_id="O2" value="-0.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percent Body Fat Change at 14 Weeks</title>
        <description>Percent by Tanita scale</description>
        <time_frame>14 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEXCOM G6 RT-CGM</title>
            <description>These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Blinded CGM</title>
            <description>These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Body Fat Change at 14 Weeks</title>
          <description>Percent by Tanita scale</description>
          <units>% change over 14 weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="3.5"/>
                    <measurement group_id="O2" value="-1.6" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes</title>
        <description>Experiences of CGM @Joslin 2009 scale of (5) strongly agree or (1) strongly disagree about statements/questions that measured the amount of satisfaction that was derived from continuous glucose monitoring. The larger the score the more satisfied participants were with CGM. 100 being the max score and 20 being the min score</description>
        <time_frame>14 weeks</time_frame>
        <population>All participants in the CGM Intervention group. Blinded group did not complete this survey</population>
        <group_list>
          <group group_id="O1">
            <title>CGM Intervention</title>
            <description>CGM intervention group</description>
          </group>
        </group_list>
        <measure>
          <title>Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes</title>
          <description>Experiences of CGM @Joslin 2009 scale of (5) strongly agree or (1) strongly disagree about statements/questions that measured the amount of satisfaction that was derived from continuous glucose monitoring. The larger the score the more satisfied participants were with CGM. 100 being the max score and 20 being the min score</description>
          <population>All participants in the CGM Intervention group. Blinded group did not complete this survey</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.8" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Glucose Change at 14 Weeks</title>
        <description>average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks</description>
        <time_frame>14 weeks</time_frame>
        <population>CGM average glucose(mg/dL)</population>
        <group_list>
          <group group_id="O1">
            <title>DEXCOM G6 RT-CGM</title>
            <description>These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Blinded CGM</title>
            <description>These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Glucose Change at 14 Weeks</title>
          <description>average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks</description>
          <population>CGM average glucose(mg/dL)</population>
          <units>% change over 14 weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="28.9"/>
                    <measurement group_id="O2" value="23.0" spread="61.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Food Frequency Change in Score at 14 Weeks</title>
        <description>Starting The Conversation (STC) is an eight-item simplified food frequency instrument/questionnaire a max score of 16 indicates poor food choices and a minimum score of 0 indicates good food choices. Results reported is change from baseline score with a negative score being a marker of improvement in food choices and a positive score being worsening of food choices</description>
        <time_frame>14 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEXCOM G6 RT-CGM</title>
            <description>These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Blinded CGM</title>
            <description>These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Food Frequency Change in Score at 14 Weeks</title>
          <description>Starting The Conversation (STC) is an eight-item simplified food frequency instrument/questionnaire a max score of 16 indicates poor food choices and a minimum score of 0 indicates good food choices. Results reported is change from baseline score with a negative score being a marker of improvement in food choices and a positive score being worsening of food choices</description>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" lower_limit="-2.8" upper_limit="0.2"/>
                    <measurement group_id="O2" value="0" lower_limit="-1.2" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Minutes Walked Per Week at 14 Weeks</title>
        <description>The International Physical Activity Questionnaire(short) is as validated questionnaire which asks the time in minutes or hours in last week you do vigorous exercise, moderate intensity exercise, walking and sitting</description>
        <time_frame>14 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEXCOM G6 RT-CGM</title>
            <description>These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Blinded CGM</title>
            <description>These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Minutes Walked Per Week at 14 Weeks</title>
          <description>The International Physical Activity Questionnaire(short) is as validated questionnaire which asks the time in minutes or hours in last week you do vigorous exercise, moderate intensity exercise, walking and sitting</description>
          <units>minutes walked per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="438.8" spread="535.4"/>
                    <measurement group_id="O2" value="232.0" spread="343.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MAGE Mean Amplitude of Glycemic Excursion</title>
        <description>this is calculation of variance of glucose for CGM</description>
        <time_frame>14 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DEXCOM G6 RT-CGM</title>
            <description>These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.</description>
          </group>
          <group group_id="O2">
            <title>Blinded CGM</title>
            <description>These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.</description>
          </group>
        </group_list>
        <measure>
          <title>MAGE Mean Amplitude of Glycemic Excursion</title>
          <description>this is calculation of variance of glucose for CGM</description>
          <units>mg/100ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.1" spread="32.3"/>
                    <measurement group_id="O2" value="90.1" spread="85.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.694</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected for 14 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>DEXCOM G6 RT-CGM</title>
          <description>These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.</description>
        </group>
        <group group_id="E2">
          <title>Blinded CGM</title>
          <description>These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </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>Dr. Nicole Ehrhardt</name_or_title>
      <organization>University of Washington Diabetes Institute</organization>
      <phone>202-741-3422</phone>
      <email>nehrhard@uw.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/NCT03805412
org study id: 180609
nct id: NCT03805412
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Evaluate the use of brief serial real time continuous monitoring (RT-CGM) as a behavior
      modification tool in obese patients with prediabetes and diabetes. After receiving RT-CGM,
      nutrition and exercise education, participants will be able to monitor their blood sugar in
      real time for 2 sessions . Education on how to interpret CGM in the setting of food choices
      and exercise coupled with nutrition and exercise information should lead to improved weight
      and other nutritional and exercise changes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percent Change in BMI From Baseline to 14 Weeks
time frame: 14 weeks
description: weight and height will be combined to report % change BMI in kg/m^2 at 14 weeks
measure: Percent Body Fat Change at 14 Weeks
time frame: 14 weeks
description: Percent by Tanita scale
measure: Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes
time frame: 14 weeks
description: Experiences of CGM @Joslin 2009 scale of (5) strongly agree or (1) strongly disagree about statements/questions that measured the amount of satisfaction that was derived from continuous glucose monitoring. The larger the score the more satisfied participants were with CGM. 100 being the max score and 20 being the min score
measure: Mean Glucose Change at 14 Weeks
time frame: 14 weeks
description: average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks
measure: Food Frequency Change in Score at 14 Weeks
time frame: 14 weeks
description: Starting The Conversation (STC) is an eight-item simplified food frequency instrument/questionnaire a max score of 16 indicates poor food choices and a minimum score of 0 indicates good food choices. Results reported is change from baseline score with a negative score being a marker of improvement in food choices and a positive score being worsening of food choices
measure: Change in Minutes Walked Per Week at 14 Weeks
time frame: 14 weeks
description: The International Physical Activity Questionnaire(short) is as validated questionnaire which asks the time in minutes or hours in last week you do vigorous exercise, moderate intensity exercise, walking and sitting
measure: MAGE Mean Amplitude of Glycemic Excursion
time frame: 14 weeks
description: this is calculation of variance of glucose for CGM
arm group label: DEXCOM G6 RT-CGM
arm group type: Active Comparator
description: These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.
arm group label: Blinded CGM
arm group type: No Intervention
description: These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.
intervention type: Device
intervention name: DEXCOM G6 RT-CGM
description: CGM is a way to measure glucose levels in real-time. A tiny electrode called a glucose sensor is inserted under the skin to measure glucose levels in tissue fluid. A small plastic piece of tube remains inserted in the skin. It is connected to a transmitter that sits on top of the skin. It is approved for use on the abdomen for 10 days. It either records the sugars downloaded in the clinic (blinded part of the study) or it sends the information via wireless radio frequency to a monitoring/ display device or to a cellular phone so participants can see data. DEXCOM G6 is FDA approved for use in patients with diabetes and will be used in accordance with instructions as approved for diabetes.
arm group label: DEXCOM G6 RT-CGM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Nicole Ehrhardt, MD
role: Principal Investigator
affiliation: George Washington University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: George Washington University
investigator full name: Nicole Ehrhardt, MD
investigator title: Endocrinologist, Principal Investigator
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Prediabetic State
mesh term: Glucose Intolerance
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 