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

Not Applicable

Completed

• Conditions: Type1diabetes; Fear of Hypoglycemia
• Interventions: Behavioral: Fear of Hypoglycemia; Other: Treatment As Usual

• Registration Number: NCT03039933
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-01
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Decrease in scores on the Hypoglycemia Fear Survey	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.

Trial Locations

Locations (1)

University of Colorado, Denver; 🇺🇸 Aurora, Colorado, United States