<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/NCT03252964</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00021722</org_study_id>
    <nct_id>NCT03252964</nct_id>
  </id_info>
  <brief_title>Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics</brief_title>
  <acronym>CGM_IRB2</acronym>
  <official_title>Empowering Medicare Patients to Self-Manage Their Type 2 Diabetes Using Continuous Glucose Monitoring (CGM) - Investigational Device Pilot</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">July 28, 2017</start_date>
  <completion_date type="Actual">February 25, 2019</completion_date>
  <primary_completion_date type="Actual">May 23, 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 three months</time_frame>
    <description>(Number of patients who signed a consent form)/(Number of patients invited to enroll)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Program Completion Rate (%)</measure>
    <time_frame>up to six months</time_frame>
    <description>(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in A1c Measurement (%)</measure>
    <time_frame>Day 0 and Day 180</time_frame>
    <description>(Final A1c measure)-(Initial A1c measure)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weekly Average of Estimated Glucose Values (EGV) (Average)</measure>
    <time_frame>up to six months</time_frame>
    <description>(Sum of EGV for one week)/(Total number of EGV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Medication Dosage (mg/Day; U/Day)</measure>
    <time_frame>up to six 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 three 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 six months</time_frame>
    <description>(Sum of age of patients who complete)/(Total number who complete)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Race of Participants Who Start the Trial (n)</measure>
    <time_frame>up to three months</time_frame>
    <description>Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ethnicity of Participants Who Start the Trial (n)</measure>
    <time_frame>up to three months</time_frame>
    <description>Sum of Hispanic or Latino and Sum of Not Hispanic or Latino</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Texting With Coaches (Daily Average of Text Messages)</measure>
    <time_frame>up to six months</time_frame>
    <description>(Sum of all text messages)/(Total number of days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coaching Participation Rate</measure>
    <time_frame>up to six months</time_frame>
    <description>(Sum of weekly coaching calls completed)/(Total number of weeks)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">52</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;
          -  Currently take a DPP4 inhibitor, SGLT2 inhibitor, GLP-1 agonist, and/or basal insulin&#xD;
&#xD;
          -  Be able to read and understand English&#xD;
&#xD;
          -  Have access to a telephone&#xD;
&#xD;
          -  Have a Medicare health plan&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Blind&#xD;
&#xD;
          -  Deaf&#xD;
&#xD;
          -  Currently receiving chemotherapy or radiation therapy to treat cancer&#xD;
&#xD;
          -  Addicted to 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>Rogelio Machuca, MD Family Medicine, PLLC</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <results_first_submitted>October 2, 2018</results_first_submitted>
  <results_first_submitted_qc>April 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 1, 2019</results_first_posted>
  <last_update_submitted>May 22, 2019</last_update_submitted>
  <last_update_submitted_qc>May 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2019</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</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>October 23, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03252964/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03252964/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>364 candidates were contacted. Of those, 52 enrolled.</recruitment_details>
      <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="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
              </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="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Program Enrollment Rate (%)</title>
        <description>(Number of patients who signed a consent form)/(Number of patients invited to enroll)</description>
        <time_frame>up to three months</time_frame>
        <population>52 participants enrolled in the study. Hence, 52 participants analyzed. However, enrollment rate is the number of participants enrolled (52) divided by the number of candidates contacted (364). This explains why the Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow.</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 signed a consent form)/(Number of patients invited to enroll)</description>
          <population>52 participants enrolled in the study. Hence, 52 participants analyzed. However, enrollment rate is the number of participants enrolled (52) divided by the number of candidates contacted (364). This explains why the Overall Number of Participants Analyzed is greater than the number Started in the Participant Flow.</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="364"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </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 49 days of CGM use) / (Number of patients who signed the consent form)</description>
        <time_frame>up to six 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>Program Completion Rate (%)</title>
          <description>(Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)</description>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in A1c Measurement (%)</title>
        <description>(Final A1c measure)-(Initial A1c measure)</description>
        <time_frame>Day 0 and Day 180</time_frame>
        <population>Lack of study resources to collect sufficient information on this variable.</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 A1c Measurement (%)</title>
          <description>(Final A1c measure)-(Initial A1c measure)</description>
          <population>Lack of study resources to collect sufficient information on this variable.</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>Weekly Average of Estimated Glucose Values (EGV) (Average)</title>
        <description>(Sum of EGV for one week)/(Total number of EGV)</description>
        <time_frame>up to six months</time_frame>
        <population>Lack of study resources to collect sufficient information on this variable.</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) (Average)</title>
          <description>(Sum of EGV for one week)/(Total number of EGV)</description>
          <population>Lack of study resources to collect sufficient information on this variable.</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>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 six months</time_frame>
        <population>Lack of study resources to collect adequate information on this variable.</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>Lack of study resources to collect adequate information on this variable.</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 three months</time_frame>
        <population>Lack of study resources to collect adequate information on this variable.</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>Lack of study resources to collect adequate information on this variable.</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 Complete Trial (Yrs)</title>
        <description>(Sum of age of patients who complete)/(Total number who complete)</description>
        <time_frame>up to six months</time_frame>
        <population>Lack of study resources to collect sufficient data on outcome variable.</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>Lack of study resources to collect sufficient data on outcome variable.</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>Race of Participants Who Start the Trial (n)</title>
        <description>Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White</description>
        <time_frame>up to three months</time_frame>
        <population>Lack of study resources to collect sufficient data on outcome variable.</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>Race of Participants Who Start the Trial (n)</title>
          <description>Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White</description>
          <population>Lack of study resources to collect sufficient data on outcome variable.</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>Ethnicity of Participants Who Start the Trial (n)</title>
        <description>Sum of Hispanic or Latino and Sum of Not Hispanic or Latino</description>
        <time_frame>up to three months</time_frame>
        <population>Lack of study resources to collect sufficient data on outcome variable.</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>Ethnicity of Participants Who Start the Trial (n)</title>
          <description>Sum of Hispanic or Latino and Sum of Not Hispanic or Latino</description>
          <population>Lack of study resources to collect sufficient data on outcome variable.</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>Texting With Coaches (Daily Average of Text Messages)</title>
        <description>(Sum of all text messages)/(Total number of days)</description>
        <time_frame>up to six months</time_frame>
        <population>Lack of study resources to collect sufficient data on outcome variable.</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>Texting With Coaches (Daily Average of Text Messages)</title>
          <description>(Sum of all text messages)/(Total number of days)</description>
          <population>Lack of study resources to collect sufficient data on outcome variable.</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>Coaching Participation Rate</title>
        <description>(Sum of weekly coaching calls completed)/(Total number of weeks)</description>
        <time_frame>up to six months</time_frame>
        <population>Lack of study resources to collect sufficient data on outcome variable.</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>Coaching Participation Rate</title>
          <description>(Sum of weekly coaching calls completed)/(Total number of weeks)</description>
          <population>Lack of study resources to collect sufficient data on outcome variable.</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_list>

    <reported_events>
      <time_frame>Up to 8 months</time_frame>
      <desc>AE and SAE were monitored in three ways:&#xD;
Participants were instructed to call the study doctor's clinical research coordinator (CRC) to report all AE and SAE related to the study devices.&#xD;
Study coaches listened for any reports of AE or SAE in their communications with participants and connected reporting patients with the CRC.&#xD;
Reports of AE or SAE received by Dexcom's Customer Care and Technical Support representatives were documented and reported to the Sponsor and CRC.</desc>
      <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>
        <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="52"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding</sub_title>
                <description>Bleeding at CGM sensor insertion site.</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <description>Pain at CGM sensor insertion site</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="52"/>
              </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, PhD</name_or_title>
      <organization>Savvysherpa, Inc.</organization>
      <phone>7635493540 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/NCT03252964
org study id: Pro00021722
nct id: NCT03252964
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 three months
description: (Number of patients who signed a consent form)/(Number of patients invited to enroll)
measure: Program Completion Rate (%)
time frame: up to six months
description: (Number of patients who complete 49 days of CGM use) / (Number of patients who signed the consent form)
measure: Change in A1c Measurement (%)
time frame: Day 0 and Day 180
description: (Final A1c measure)-(Initial A1c measure)
measure: Weekly Average of Estimated Glucose Values (EGV) (Average)
time frame: up to six months
description: (Sum of EGV for one week)/(Total number of EGV)
measure: Change in Medication Dosage (mg/Day; U/Day)
time frame: up to six 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 three 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 six months
description: (Sum of age of patients who complete)/(Total number who complete)
measure: Race of Participants Who Start the Trial (n)
time frame: up to three months
description: Sum of American Indian or Alaska Native, Sum of Asian, Sum of Black or African American, Sum of Native Hawaiian or Other Pacific Islander, Sum of White
measure: Ethnicity of Participants Who Start the Trial (n)
time frame: up to three months
description: Sum of Hispanic or Latino and Sum of Not Hispanic or Latino
measure: Texting With Coaches (Daily Average of Text Messages)
time frame: up to six months
description: (Sum of all text messages)/(Total number of days)
measure: Coaching Participation Rate
time frame: up to six months
description: (Sum of weekly coaching calls completed)/(Total number of 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: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 