<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/NCT03263494</url>
  </required_header>
  <id_info>
    <org_study_id>CITY</org_study_id>
    <nct_id>NCT03263494</nct_id>
  </id_info>
  <brief_title>CGM Intervention in Teens and Young Adults With Type 1 Diabetes (T1D)</brief_title>
  <acronym>CITY</acronym>
  <official_title>CGM Intervention in Teens and Young Adults With T1D (CITY): A Randomized Clinical Trial to Assess the Efficacy and Safety of Continuous Glucose Monitoring in Young Adults 14-&lt;25 With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jaeb Center for Health Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Leona M. and Harry B. Helmsley Charitable Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jaeb Center for Health Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adolescents and young adults with T1D and poor glycemic control (age 14-&lt; 25 years, T1D&#xD;
      duration &gt;12 months, HbA1c 7.5-&lt;11.0%, using an insulin pump or MDI)) will be randomly&#xD;
      assigned to either CGM or BGM. Sample size will be 150. The primary outcome assessment will&#xD;
      be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group&#xD;
      will wear blinded CGM at 13 and 24 weeks), and quality of life measures. The randomized trial&#xD;
      will be followed by a 6-month extension study during which the RCT control group will&#xD;
      initiate CGM and the RCT CGM group will continue CGM.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2018</start_date>
  <completion_date type="Actual">November 7, 2019</completion_date>
  <primary_completion_date type="Actual">May 8, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in HbA1c from baseline to 26 weeks adjusted for baseline</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>% with HbA1c &lt;7.0%</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% with HbA1c &lt;7.5%</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% with relative reduction ≥ 10%</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% with absolute reduction ≥ 0.5%</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% with absolute reduction ≥ 1%</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% with absolute reduction ≥ 1% or HbA1c &lt; 7.0%</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM % time in range 70-180 mg/dl</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM mean glucose</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM glucose variability measured by coefficient of variation</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM % time &gt; 180 mg/dl</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM % time &gt; 300 mg/dl</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM % time &lt; 54 mg/dl</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM % time &lt; 70 mg/dl</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of CGM measured hypoglycemic episodes (using &lt;54 mg/dL)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGM Self Efficacy Questionnaire Score</measure>
    <time_frame>6 months</time_frame>
    <description>Questionnaire containing 15 questions with possible responses 0-6. Total score is calculated by taking the mean of the non-missing responses. Then multiply by 100 and divide by 6 to put on the scale 0-100. Higher total score indicates higher perceived ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Problem Areas in Diabetes (PAID) Questionnaire Score</measure>
    <time_frame>6 months</time_frame>
    <description>Survey containing 20 questions with possible responses 0-5. Total score is calculated by taking the mean of the non-missing items and multiplying by 20 to put on the scale 0-100. A higher total score indicates more of a problem.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose Monitoring Satisfaction Questionnaire Score</measure>
    <time_frame>6 months</time_frame>
    <description>Survey containing 15 questions. Total score ranges from 0-100. A higher total score indicates more satisfaction with their current glucose monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia Confidence Questionnaire Score</measure>
    <time_frame>6 months</time_frame>
    <description>Survey containing 9 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates more confidence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diabetes Technology Attitudes Questionnaire Score</measure>
    <time_frame>6 months</time_frame>
    <description>Survey containing 5 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates a more positive attitude towards diabetes technology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>6 months</time_frame>
    <description>Survey containing 19 questions. Total score ranges from 0-21. A lower score indicates a healthier sleep quality.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>CGM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BGM</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Continuous Glucose Monitor (CGM)</intervention_name>
    <description>Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.</description>
    <arm_group_label>CGM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of T1D, with either age of T1D diagnosis &lt; 10 years of age OR a&#xD;
             history of positive T1D related antibodies in the medical record&#xD;
&#xD;
          2. Age 14-&lt;25 years&#xD;
&#xD;
          3. Diabetes duration ≥ 1 year&#xD;
&#xD;
          4. Total daily insulin requirement ≥ 0.4 units/kg/day&#xD;
&#xD;
          5. HbA1c 7.5% to &lt;11.0% (Point of care device or local lab measured as part of study at&#xD;
             screening visit)&#xD;
&#xD;
          6. Insulin regimen involves a consistent modality of insulin administration with either&#xD;
             use of an insulin pump or at least 3 multiple daily injections of basal and bolus&#xD;
             (meal time) analogue insulin. Insulin pump must not have been started within 3 months&#xD;
             of consent with no plans to change regimens in the next 6 months&#xD;
&#xD;
          7. Perform at least 2 blood glucose meter checks per day from self-report at screening&#xD;
             and an average of at least 2 checks per day from meter download during blinded CGM run&#xD;
             in&#xD;
&#xD;
          8. Blinded CGM must be used a minimum of 200 hours (equivalent to 8.3 days) with an&#xD;
             average of 1.8 calibrations per day during the blinded CGM screening period.&#xD;
&#xD;
          9. Participant comprehends written and spoken English&#xD;
&#xD;
         10. Participant understands the study protocol and agrees to it (if applicable)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Use of unblinded personal CGM and/or flash CGM, outside of a research study, as part&#xD;
             of real-time diabetes management in the last 3 months&#xD;
&#xD;
          2. Unable to use CGM device for minimum number of hours during blinded pre-randomization&#xD;
             period or skin reaction from adhesive that would preclude participation in the&#xD;
             randomized trial&#xD;
&#xD;
          3. Started on non-insulin medication for blood glucose control within the past 3 months&#xD;
             or plans to begin within the next 6 months&#xD;
&#xD;
          4. The presence of a significant medical disorder that in the judgment of the&#xD;
             investigator will affect the wearing of the sensors (such as a skin condition), or the&#xD;
             completion of any aspect of the protocol.&#xD;
&#xD;
          5. More than 1 episode of DKA in the past 6 months as defined in the adverse events&#xD;
             chapter.&#xD;
&#xD;
          6. The presence of any of the following diseases:&#xD;
&#xD;
               -  Asthma or any condition present in the last 6 months where treatment is a&#xD;
                  systemic or daily inhaled corticosteroid (Intermittent treatment with inhaled&#xD;
                  corticosteroids does not exclude subjects from enrollment)&#xD;
&#xD;
               -  Cystic fibrosis&#xD;
&#xD;
               -  Addison's disease (Adequately treated thyroid disease and celiac disease do not&#xD;
                  exclude subjects from enrollment)&#xD;
&#xD;
          7. Inpatient psychiatric treatment in the past 6 months or daily intensive outpatient&#xD;
             psychiatric day treatment in the past 3 months.&#xD;
&#xD;
          8. Pregnant (positive test confirmed at screening) or planning to become pregnant in the&#xD;
             next 12 months.&#xD;
&#xD;
          9. Need for use of acetaminophen or acetaminophen-containing products on a regular basis&#xD;
             during the 6 months of the trial&#xD;
&#xD;
         10. Participation in a diabetes related intervention study in the past 6 weeks.&#xD;
&#xD;
         11. Any medical, psychological or social situation where per investigator discretion it&#xD;
             may be difficult for participant to participate fully in the intervention&#xD;
&#xD;
         12. Any condition, per investigator assessment, that could impact reliability of the A1C&#xD;
             measurement, such as (but not limited to) hemoglobinopathy, hemolytic anemia, chronic&#xD;
             liver disease; chronic GI blood loss, red blood cell transfusion or erythropoietin&#xD;
             administration within 3 months prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Davis Center--University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Diabetes &amp; Osteoporosis Center</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joslin Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IDC at Park Nicollet</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naomi Berrie Diabetes Center at Columbia University</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>March 2, 2020</last_update_submitted>
  <last_update_submitted_qc>March 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</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</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>April 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03263494/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>August 12, 2020</submitted>
    <returned>August 26, 2020</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03263494
org study id: CITY
nct id: NCT03263494
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Adolescents and young adults with T1D and poor glycemic control (age 14-< 25 years, T1D
      duration >12 months, HbA1c 7.5-<11.0%, using an insulin pump or MDI)) will be randomly
      assigned to either CGM or BGM. Sample size will be 150. The primary outcome assessment will
      be HbA1c after 6 months. Secondary outcomes will include HbA1c, CGM metrics (control group
      will wear blinded CGM at 13 and 24 weeks), and quality of life measures. The randomized trial
      will be followed by a 6-month extension study during which the RCT control group will
      initiate CGM and the RCT CGM group will continue CGM.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in HbA1c from baseline to 26 weeks adjusted for baseline
time frame: 6 months
measure: % with HbA1c <7.0%
time frame: 6 months
measure: % with HbA1c <7.5%
time frame: 6 months
measure: % with relative reduction ≥ 10%
time frame: 6 months
measure: % with absolute reduction ≥ 0.5%
time frame: 6 months
measure: % with absolute reduction ≥ 1%
time frame: 6 months
measure: % with absolute reduction ≥ 1% or HbA1c < 7.0%
time frame: 6 months
measure: CGM % time in range 70-180 mg/dl
time frame: 6 months
measure: CGM mean glucose
time frame: 6 months
measure: CGM glucose variability measured by coefficient of variation
time frame: 6 months
measure: CGM % time > 180 mg/dl
time frame: 6 months
measure: CGM % time > 300 mg/dl
time frame: 6 months
measure: CGM % time < 54 mg/dl
time frame: 6 months
measure: CGM % time < 70 mg/dl
time frame: 6 months
measure: Rate of CGM measured hypoglycemic episodes (using <54 mg/dL)
time frame: 6 months
measure: CGM Self Efficacy Questionnaire Score
time frame: 6 months
description: Questionnaire containing 15 questions with possible responses 0-6. Total score is calculated by taking the mean of the non-missing responses. Then multiply by 100 and divide by 6 to put on the scale 0-100. Higher total score indicates higher perceived ability.
measure: Problem Areas in Diabetes (PAID) Questionnaire Score
time frame: 6 months
description: Survey containing 20 questions with possible responses 0-5. Total score is calculated by taking the mean of the non-missing items and multiplying by 20 to put on the scale 0-100. A higher total score indicates more of a problem.
measure: Glucose Monitoring Satisfaction Questionnaire Score
time frame: 6 months
description: Survey containing 15 questions. Total score ranges from 0-100. A higher total score indicates more satisfaction with their current glucose monitor.
measure: Hypoglycemia Confidence Questionnaire Score
time frame: 6 months
description: Survey containing 9 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates more confidence.
measure: Diabetes Technology Attitudes Questionnaire Score
time frame: 6 months
description: Survey containing 5 questions with possible responses 0-4. Total score is calculated by taking the mean of non-missing responses and multiplying by 25 to put on the scale 0-100. Higher total score indicates a more positive attitude towards diabetes technology.
measure: Pittsburgh Sleep Quality Index
time frame: 6 months
description: Survey containing 19 questions. Total score ranges from 0-21. A lower score indicates a healthier sleep quality.
arm group label: CGM
arm group type: Active Comparator
arm group label: BGM
arm group type: No Intervention
intervention type: Device
intervention name: Continuous Glucose Monitor (CGM)
description: Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
arm group label: CGM
criteria: 
gender: All
minimum age: 14 Years
maximum age: 24 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
provided document: 
submitted: August 12, 2020
returned: August 26, 2020