<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/NCT03297762</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-36423</org_study_id>
    <nct_id>NCT03297762</nct_id>
  </id_info>
  <brief_title>Increasing Use of Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes</brief_title>
  <official_title>Improving Adherence to Continuous Glucose Monitors in Publicly-insured Youth With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To use an enhanced continuous glucose monitor (CGM) experience, including an automated&#xD;
      CGM-electronic health record (EHR) data integration system, proactive interventions, and&#xD;
      gamification techniques, to increase CGM use among publicly-insured youth with type 1&#xD;
      diabetes (T1D).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will use an automated data integration system to monitor hours per week the&#xD;
      CGM is worn and target interventions/troubleshooting techniques as needed. The investigators&#xD;
      will use gamification techniques (i.e. ability to gain points and achieve small rewards) to&#xD;
      help encourage CGM use and potentially improve glycemic control in this at-risk population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Enrollment challenges&#xD;
  </why_stopped>
  <start_date type="Actual">May 7, 2018</start_date>
  <completion_date type="Actual">June 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CGM use</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>amount of time per week CGM is used</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hgb A1c</measure>
    <time_frame>baseline to 6 months</time_frame>
    <description>glycemic control as measured by Hgb A1c</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Type1diabetes</condition>
  <arm_group>
    <arm_group_label>Gamification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of continuous glucose monitor (Dexcom G5) per usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>gamification</intervention_name>
    <description>incentives/rewards and contact between standard visits</description>
    <arm_group_label>Gamification</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Use of Dexcom G5</intervention_name>
    <description>Dexcom G5 continuous glucose monitor</description>
    <arm_group_label>Gamification</arm_group_label>
    <arm_group_label>Standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  type 1 diabetes for more than 6 months&#xD;
&#xD;
          -  on insulin pump or multiple daily injections without plans to change modality in next&#xD;
             6 months&#xD;
&#xD;
          -  insured by CCS or Medi-Cal&#xD;
&#xD;
          -  receiving care at Lucile Packard Children's Hospital or Stanford Children's Health&#xD;
             outpatient clinics&#xD;
&#xD;
          -  English or Spanish-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major illness or condition that may alter glucose control or ability to complete the&#xD;
             study including pregnancy, cystic fibrosis, cancer, liver disease, history of&#xD;
             transplant, or hemoglobinopathy&#xD;
&#xD;
          -  current oral glucocorticoid use&#xD;
&#xD;
          -  prior use of a CGM system&#xD;
&#xD;
          -  hemoglobin A1C &lt;7.5% or &gt;12%&#xD;
&#xD;
          -  no wireless internet access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria Chang, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Children's</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>April 16, 2020</last_update_submitted>
  <last_update_submitted_qc>April 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Darrell M Wilson</investigator_full_name>
    <investigator_title>Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03297762
org study id: IRB-36423
nct id: NCT03297762
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
To use an enhanced continuous glucose monitor (CGM) experience, including an automated
      CGM-electronic health record (EHR) data integration system, proactive interventions, and
      gamification techniques, to increase CGM use among publicly-insured youth with type 1
      diabetes (T1D).
The investigators will use an automated data integration system to monitor hours per week the
      CGM is worn and target interventions/troubleshooting techniques as needed. The investigators
      will use gamification techniques (i.e. ability to gain points and achieve small rewards) to
      help encourage CGM use and potentially improve glycemic control in this at-risk population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: CGM use
time frame: baseline to 6 months
description: amount of time per week CGM is used
measure: Hgb A1c
time frame: baseline to 6 months
description: glycemic control as measured by Hgb A1c
arm group label: Gamification
arm group type: Experimental
description: Use of continuous glucose monitor (Dexcom G5) with proactive intervention and incentives for time in use.
arm group label: Standard care
arm group type: Active Comparator
description: Use of continuous glucose monitor (Dexcom G5) per usual care.
intervention type: Behavioral
intervention name: gamification
description: incentives/rewards and contact between standard visits
arm group label: Gamification
intervention type: Behavioral
intervention name: Use of Dexcom G5
description: Dexcom G5 continuous glucose monitor
arm group label: Gamification
arm group label: Standard care
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
healthy volunteers: No
last name: Maria Chang, MD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Darrell M Wilson
investigator title: Professor of Pediatrics
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No