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

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039933
• Other study ID #: 16-0645
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2020

Study information

• Verified date: September 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Fear of Hypoglycemia
• Hypoglycemia
• Type1diabetes

Intervention

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

Other:
• Treatment As Usual
Treatment As Usual

Locations

Country	Name	City	State
United States	University of Colorado, Denver	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in scores on the Hypoglycemia Fear Survey	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.	Baseline, 3 and 6 months