<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/NCT03290768</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00022589</org_study_id>
    <nct_id>NCT03290768</nct_id>
  </id_info>
  <brief_title>Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3)</brief_title>
  <acronym>CGM_IRB-3</acronym>
  <official_title>Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot (SMA Investigational Device)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Savvysherpa, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Savvysherpa, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor&#xD;
      (CGM) as part of an educational program designed to help them better manage their glucose&#xD;
      levels. Subjects will also wear an activity tracker to monitor their activity and observe its&#xD;
      effect on their glucose levels. The educational program will involve calls from coaches to&#xD;
      check subjects' progress and answer questions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Program Enrollment Rate (%)</measure>
    <time_frame>up to 9 months</time_frame>
    <description>(Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Program Completion Rate (%)</measure>
    <time_frame>up to 9 months</time_frame>
    <description>(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weekly Average of Estimated Glucose Values (EGV)</measure>
    <time_frame>up to 10 weeks</time_frame>
    <description>(Sum of EGV for a given week) / (Total number of EGV for a given week)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medication Dosage (mg/Day; U/Day)</measure>
    <time_frame>up to 9 months</time_frame>
    <description>(dosage of Rx on Day 180) - (dosage of Rx on Day 0)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Age of Participants Who Start Trial (Yrs)</measure>
    <time_frame>up to 9 months</time_frame>
    <description>(Sum of ages of all enrollees) / (Total number of enrollees)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Age of Participants Who Complete Trial (Yrs)</measure>
    <time_frame>up to 9 months</time_frame>
    <description>(Sum of age of patients who complete) / (Total number who complete)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Texting With Coaches</measure>
    <time_frame>up to 9 months</time_frame>
    <description>(Sum of all text messages) / (Total number of participants*days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coaching Participation Rate</measure>
    <time_frame>up to 9 months</time_frame>
    <description>(Sum of weekly coaching calls completed) / (Total number of participants*weeks)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">358</enrollment>
  <condition>Type2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Diabetes Management Educational Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Glucose Monitor (CGM)</intervention_name>
    <description>Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.</description>
    <arm_group_label>Diabetes Management Educational Program</arm_group_label>
    <other_name>Dexcom Investigational Use Only (IUO) Device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Activity Tracker</intervention_name>
    <description>Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.</description>
    <arm_group_label>Diabetes Management Educational Program</arm_group_label>
    <other_name>Fitbit Charge 2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coaching</intervention_name>
    <description>Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
    <arm_group_label>Diabetes Management Educational Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be diagnosed with type 2 diabetes&#xD;
&#xD;
          -  Be able to read and understand English&#xD;
&#xD;
          -  Have access to a telephone&#xD;
&#xD;
          -  Have a Medicare Advantage health plan through Senior Dimensions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Blind&#xD;
&#xD;
          -  Deaf&#xD;
&#xD;
          -  Receiving chemotherapy or radiation to treat cancer (now or in past 6 months)&#xD;
&#xD;
          -  Misusing any drugs (including alcohol, painkillers, hallucinogens, or others)&#xD;
&#xD;
          -  Critically ill&#xD;
&#xD;
          -  Diagnosed with or experiencing:&#xD;
&#xD;
               -  Kidney disease stages 4 and 5&#xD;
&#xD;
               -  End stage renal disease&#xD;
&#xD;
               -  Severe liver disease&#xD;
&#xD;
               -  Dementia&#xD;
&#xD;
               -  Schizophrenia&#xD;
&#xD;
               -  Bipolar disorder&#xD;
&#xD;
               -  Autism&#xD;
&#xD;
               -  An intellectual or learning disability&#xD;
&#xD;
               -  Arrhythmias other than atrial fibrillation&#xD;
&#xD;
               -  Congestive heart failure&#xD;
&#xD;
          -  Has had a:&#xD;
&#xD;
               -  Myocardial infarction within the last 6 months&#xD;
&#xD;
               -  Stroke within the last 6 months&#xD;
&#xD;
               -  Stroke that resulted in significant disability (e.g., unable to write clearly or&#xD;
                  walk)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Southwest Medical Associates</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>May 23, 2019</results_first_submitted>
  <results_first_submitted_qc>June 25, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 16, 2019</results_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 19, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03290768/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Diabetes Management Educational Program</title>
          <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="358"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="193"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="165"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Diabetes Management Educational Program</title>
          <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="358"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Two participants lacked age data.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="356"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.4" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Three participants lacked gender data.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="355"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="184"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Program Enrollment Rate (%)</title>
        <description>(Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100</description>
        <time_frame>up to 9 months</time_frame>
        <population>Note that the number analyzed is greater than the number of participants (358) because participants are a subset of those who were invited to participate.</population>
        <group_list>
          <group group_id="O1">
            <title>Diabetes Management Educational Program</title>
            <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Program Enrollment Rate (%)</title>
          <description>(Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100</description>
          <population>Note that the number analyzed is greater than the number of participants (358) because participants are a subset of those who were invited to participate.</population>
          <units>percentage of invitees</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5896"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Program Completion Rate (%)</title>
        <description>(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100</description>
        <time_frame>up to 9 months</time_frame>
        <population>Unit of measure, below, should read, &quot;percentage of participants completing 10 weeks of CGM,&quot; but there is not enough space.</population>
        <group_list>
          <group group_id="O1">
            <title>Diabetes Management Educational Program</title>
            <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Program Completion Rate (%)</title>
          <description>(Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100</description>
          <population>Unit of measure, below, should read, &quot;percentage of participants completing 10 weeks of CGM,&quot; but there is not enough space.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Weekly Average of Estimated Glucose Values (EGV)</title>
        <description>(Sum of EGV for a given week) / (Total number of EGV for a given week)</description>
        <time_frame>up to 10 weeks</time_frame>
        <population>358 Participants started the study, but participants dropped out as time passed. By week 10, there were only 193 participants remaining who were providing EGV.</population>
        <group_list>
          <group group_id="O1">
            <title>Diabetes Management Educational Program</title>
            <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Weekly Average of Estimated Glucose Values (EGV)</title>
          <description>(Sum of EGV for a given week) / (Total number of EGV for a given week)</description>
          <population>358 Participants started the study, but participants dropped out as time passed. By week 10, there were only 193 participants remaining who were providing EGV.</population>
          <units>milligrams/deciliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="358"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153.9" spread="59.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="286"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.7" spread="57.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="275"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.3" spread="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="266"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.9" spread="57.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="254"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.5" spread="54.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="242"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.1" spread="52.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="225"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149.9" spread="52.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="219"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149.4" spread="54.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="210"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.0" spread="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149.6" spread="54.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Medication Dosage (mg/Day; U/Day)</title>
        <description>(dosage of Rx on Day 180) - (dosage of Rx on Day 0)</description>
        <time_frame>up to 9 months</time_frame>
        <population>After starting the study, administrator realized that it would not be able to obtain medication data from participants. There is no data to report for this measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Diabetes Management Educational Program</title>
            <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Medication Dosage (mg/Day; U/Day)</title>
          <description>(dosage of Rx on Day 180) - (dosage of Rx on Day 0)</description>
          <population>After starting the study, administrator realized that it would not be able to obtain medication data from participants. There is no data to report for this measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Age of Participants Who Start Trial (Yrs)</title>
        <description>(Sum of ages of all enrollees) / (Total number of enrollees)</description>
        <time_frame>up to 9 months</time_frame>
        <population>Two of the 358 participants who started the study lacked age data.</population>
        <group_list>
          <group group_id="O1">
            <title>Diabetes Management Educational Program</title>
            <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Age of Participants Who Start Trial (Yrs)</title>
          <description>(Sum of ages of all enrollees) / (Total number of enrollees)</description>
          <population>Two of the 358 participants who started the study lacked age data.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="356"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71.4" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Age of Participants Who Complete Trial (Yrs)</title>
        <description>(Sum of age of patients who complete) / (Total number who complete)</description>
        <time_frame>up to 9 months</time_frame>
        <population>One of the 193 participants who completed 10 weeks of CGM use lacked age data.</population>
        <group_list>
          <group group_id="O1">
            <title>Diabetes Management Educational Program</title>
            <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Age of Participants Who Complete Trial (Yrs)</title>
          <description>(Sum of age of patients who complete) / (Total number who complete)</description>
          <population>One of the 193 participants who completed 10 weeks of CGM use lacked age data.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="192"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.6" spread="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Texting With Coaches</title>
        <description>(Sum of all text messages) / (Total number of participants*days)</description>
        <time_frame>up to 9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Diabetes Management Educational Program</title>
            <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Texting With Coaches</title>
          <description>(Sum of all text messages) / (Total number of participants*days)</description>
          <units>text messages per participant per day</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.003"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Coaching Participation Rate</title>
        <description>(Sum of weekly coaching calls completed) / (Total number of participants*weeks)</description>
        <time_frame>up to 9 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Diabetes Management Educational Program</title>
            <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
          </group>
        </group_list>
        <measure>
          <title>Coaching Participation Rate</title>
          <description>(Sum of weekly coaching calls completed) / (Total number of participants*weeks)</description>
          <units>calls per participant per week</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="358"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10 weeks per participant</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Diabetes Management Educational Program</title>
          <description>Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.&#xD;
Continuous Glucose Monitor (CGM): Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.&#xD;
Activity Tracker: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.&#xD;
Coaching: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="358"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="358"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Death from Cardiopulmonary Arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="358"/>
              </event>
              <event>
                <sub_title>Death from artherosclerotic and hypertensive heart disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="358"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="358"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="358"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bleeding at Insertion Site</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="358"/>
              </event>
              <event>
                <sub_title>Bruising at Insertion Site</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="358"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Detached/Broken Sensor Wire</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="358"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Redness/Rash at insertion site</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="358"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jared Jones</name_or_title>
      <organization>Savvysherpa, LLC</organization>
      <phone>763-549-3540 ext 8116</phone>
      <email>JaredJones@savvysherpa.com</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/NCT03290768
org study id: Pro00022589
nct id: NCT03290768
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This study allows Type 2 diabetics to receive feedback from a continuous glucose monitor
      (CGM) as part of an educational program designed to help them better manage their glucose
      levels. Subjects will also wear an activity tracker to monitor their activity and observe its
      effect on their glucose levels. The educational program will involve calls from coaches to
      check subjects' progress and answer questions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Program Enrollment Rate (%)
time frame: up to 9 months
description: (Number of patients who were shipped devices) / (Number of patients invited to enroll) * 100
measure: Program Completion Rate (%)
time frame: up to 9 months
description: (Number of patients who complete 10 weeks of CGM) / (Number of patients who received devices) * 100
measure: Weekly Average of Estimated Glucose Values (EGV)
time frame: up to 10 weeks
description: (Sum of EGV for a given week) / (Total number of EGV for a given week)
measure: Change in Medication Dosage (mg/Day; U/Day)
time frame: up to 9 months
description: (dosage of Rx on Day 180) - (dosage of Rx on Day 0)
measure: Average Age of Participants Who Start Trial (Yrs)
time frame: up to 9 months
description: (Sum of ages of all enrollees) / (Total number of enrollees)
measure: Average Age of Participants Who Complete Trial (Yrs)
time frame: up to 9 months
description: (Sum of age of patients who complete) / (Total number who complete)
measure: Texting With Coaches
time frame: up to 9 months
description: (Sum of all text messages) / (Total number of participants*days)
measure: Coaching Participation Rate
time frame: up to 9 months
description: (Sum of weekly coaching calls completed) / (Total number of participants*weeks)
arm group label: Diabetes Management Educational Program
arm group type: Experimental
description: Subjects receive a CGM and activity tracker as part of a educational program to help manage their glucose levels.
intervention type: Device
intervention name: Continuous Glucose Monitor (CGM)
description: Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
arm group label: Diabetes Management Educational Program
other name: Dexcom Investigational Use Only (IUO) Device
intervention type: Device
intervention name: Activity Tracker
description: Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.
arm group label: Diabetes Management Educational Program
other name: Fitbit Charge 2
intervention type: Behavioral
intervention name: Coaching
description: Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.
arm group label: Diabetes Management Educational Program
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 