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

University of Colorado, Denver43 enrolled

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type1diabetes Fear of Hypoglycemia

Interventions

Fear of HypoglycemiaBEHAVIORAL

Participants will receive exposure and response prevention and/or hypoglycemia awareness training.

Treatment As UsualOTHER

Treatment As Usual

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Colorado, Denver

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 3 and 6 months

Data from ClinicalTrials.gov

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