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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Fear of Hypoglycemia; Type1diabetes

Treatments: Behavioral: Fear of Hypoglycemia; Other: Treatment As Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03039933

16-0645

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

Fear of Hypoglycemia Intervention

Active Comparator group

Description:

Cognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks.

Treatment:

Behavioral: Fear of Hypoglycemia

Treatment As Usual

Other group

Description:

Control group completes questionnaires but does not receive any study intervention. Receives medical care as usual.

Treatment:

Other: Treatment As Usual