<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/NCT03228004</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201700818</org_study_id>
    <nct_id>NCT03228004</nct_id>
  </id_info>
  <brief_title>Type 1 Diabetes Data Acquisition and Transfer Adherence Study</brief_title>
  <acronym>T1D-DATA</acronym>
  <official_title>Type 1 Diabetes Data Acquisition and Transfer Adherence Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this pilot study is to determine if training and support, combined with&#xD;
      reminders to facilitate glucose data sharing with the diabetes care team in between clinic&#xD;
      visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have&#xD;
      HbA1c levels above target.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Actual">April 8, 2019</completion_date>
  <primary_completion_date type="Actual">April 24, 2018</primary_completion_date>
  <phase>Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improved glycemic control</measure>
    <time_frame>16 weeks</time_frame>
    <description>HbA1c</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Frequency of data upload</measure>
    <time_frame>16 weeks</time_frame>
    <description>The number of times glucose data is uploaded between clinic visits</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be provided with training on how to upload glucose data via GLOOKO and will receive reminders to upload glucose data on a biweekly basis between clinic visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Glooko MeterSync</intervention_name>
    <description>The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis with T1D at least 6 months before consent is obtained&#xD;
&#xD;
          -  Aged ≥ 2 years and ≤17 years at time of enrollment&#xD;
&#xD;
          -  Must have access to a smartphone, tablet or computer at home with wireless&#xD;
             connectivity&#xD;
&#xD;
          -  Last HbA1c of ≥7.6% and ≤11%&#xD;
&#xD;
          -  Using fixed doses, multiple daily injections or an insulin pump as primary diabetes&#xD;
             management regimen&#xD;
&#xD;
          -  Ability to read and speak English&#xD;
&#xD;
          -  Patient at UF Health Pediatric Diabetes Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant medical comorbidity in the child or adolescent that could, in the opinion&#xD;
             of the PI, affect participant's capacity to complete study follow up&#xD;
&#xD;
          -  Inability to read and speak English&#xD;
&#xD;
          -  Not using insulin therapy&#xD;
&#xD;
          -  Lack of access to mobile device or computer with wireless internet connectivity&#xD;
&#xD;
          -  Unwilling or unable to use clinic's software (Glooko) to facilitate glucose data&#xD;
             upload&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anastasia Albanese-O'Neill, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>April 10, 2019</last_update_submitted>
  <last_update_submitted_qc>April 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 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</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <!-- 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/NCT03228004
org study id: IRB201700818
nct id: NCT03228004
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this pilot study is to determine if training and support, combined with
      reminders to facilitate glucose data sharing with the diabetes care team in between clinic
      visits, can improve glycemic outcomes for patients ages 10-17 with type 1 diabetes who have
      HbA1c levels above target.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improved glycemic control
time frame: 16 weeks
description: HbA1c
measure: Frequency of data upload
time frame: 16 weeks
description: The number of times glucose data is uploaded between clinic visits
arm group label: Intervention Group
arm group type: Experimental
description: Participants will be provided with training on how to upload glucose data via GLOOKO and will receive reminders to upload glucose data on a biweekly basis between clinic visits.
intervention type: Behavioral
intervention name: Glooko MeterSync
description: The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Anastasia Albanese-O'Neill, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1