<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/NCT03039933</url>
  </required_header>
  <id_info>
    <org_study_id>16-0645</org_study_id>
    <nct_id>NCT03039933</nct_id>
  </id_info>
  <brief_title>Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes</brief_title>
  <official_title>Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03)&#xD;
      is to address the critical need of identifying and decreasing fear of hypoglycemia, which&#xD;
      will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy&#xD;
      of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in&#xD;
      adolescents with Type 1 Diabetes (T1D) and their parents.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">August 2020</completion_date>
  <primary_completion_date type="Actual">August 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease in scores on the Hypoglycemia Fear Survey</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>To address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by evaluating the efficacy of Blood Glucose Awareness Training as compared to treatment as usual.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Type1diabetes</condition>
  <condition>Fear of Hypoglycemia</condition>
  <arm_group>
    <arm_group_label>Fear of Hypoglycemia Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment As Usual</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control group completes questionnaires but does not receive any study intervention. Receives medical care as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fear of Hypoglycemia</intervention_name>
    <description>Participants will receive exposure and response prevention and/or hypoglycemia awareness training.</description>
    <arm_group_label>Fear of Hypoglycemia Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment As Usual</intervention_name>
    <description>Treatment As Usual</description>
    <arm_group_label>Treatment As Usual</arm_group_label>
    <other_name>Standard of Care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adolescents aged 10-17 years and their parent(s) or legal guardian;&#xD;
&#xD;
          -  T1D duration &gt;1 year;&#xD;
&#xD;
          -  insulin pump use &gt;6 months;&#xD;
&#xD;
          -  agreement of both parent and adolescent to participate in intervention sessions;&#xD;
&#xD;
          -  elevated scores on the Parent Hypoglycemia Fear Survey - Behavior Subscale.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  developmental disability or reading disorder that prevents understanding of the&#xD;
             intervention materials; and&#xD;
&#xD;
          -  non-English speaking adolescents and parents.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly Driscoll, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado, Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 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</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    <mesh_term>Hypoglycemia</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/NCT03039933
org study id: 16-0645
nct id: NCT03039933
lead sponsor: 
collaborator: 
has dmc: No
The overall objective and Primary Aim of this Limited Competition: Small Grant Program (R03)
      is to address the critical need of identifying and decreasing fear of hypoglycemia, which
      will be accomplished by conducting a pilot randomized clinical trial to evaluate the efficacy
      of Blood Glucose Awareness Training, which has been adapted for, but never evaluated in
      adolescents with Type 1 Diabetes (T1D) and their parents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Decrease in scores on the Hypoglycemia Fear Survey
time frame: Baseline, 3 and 6 months
description: To address the critical need of identifying and decreasing fear of hypoglycemia, which will be accomplished by evaluating the efficacy of Blood Glucose Awareness Training as compared to treatment as usual.
arm group label: Fear of Hypoglycemia Intervention
arm group type: Active Comparator
description: Cognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks.
arm group label: Treatment As Usual
arm group type: Other
description: Control group completes questionnaires but does not receive any study intervention. Receives medical care as usual.
intervention type: Behavioral
intervention name: Fear of Hypoglycemia
description: Participants will receive exposure and response prevention and/or hypoglycemia awareness training.
arm group label: Fear of Hypoglycemia Intervention
intervention type: Other
intervention name: Treatment As Usual
description: Treatment As Usual
arm group label: Treatment As Usual
other name: Standard of Care
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Kimberly Driscoll, Ph.D.
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
mesh term: Hypoglycemia
sharing ipd: No