Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2020

Interventions

  • Behavioral: Fear of Hypoglycemia
    • Participants will receive exposure and response prevention and/or hypoglycemia awareness training.
  • Other: Treatment As Usual
    • Treatment As Usual

Arms, Groups and Cohorts

  • Active Comparator: Fear of Hypoglycemia Intervention
    • Cognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks.
  • Other: Treatment As Usual
    • Control group completes questionnaires but does not receive any study intervention. Receives medical care as usual.

Clinical Trial Outcome Measures

Primary Measures

  • Decrease in scores on the Hypoglycemia Fear Survey
    • Time Frame: Baseline, 3 and 6 months
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • adolescents aged 10-17 years and their parent(s) or legal guardian; – T1D duration >1 year; – insulin pump use >6 months; – agreement of both parent and adolescent to participate in intervention sessions; – elevated scores on the Parent Hypoglycemia Fear Survey – Behavior Subscale. Exclusion Criteria:

  • developmental disability or reading disorder that prevents understanding of the intervention materials; and – non-English speaking adolescents and parents.

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Collaborator
    • University of Virginia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kimberly Driscoll, Ph.D., Principal Investigator, University of Colorado, Denver

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