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

Primary Purpose

Type1diabetes, Fear of Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fear of Hypoglycemia
Treatment As Usual
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type1diabetes

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • University of Colorado, Denver

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Fear of Hypoglycemia Intervention

Treatment As Usual

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2016
Last Updated
September 8, 2021
Sponsor
University of Colorado, Denver
Collaborators
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT03039933
Brief Title
Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
Official Title
Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes, Fear of Hypoglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fear of Hypoglycemia Intervention
Arm Type
Active Comparator
Arm Description
Cognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks.
Arm Title
Treatment As Usual
Arm Type
Other
Arm Description
Control group completes questionnaires but does not receive any study intervention. Receives medical care as usual.
Intervention Type
Behavioral
Intervention Name(s)
Fear of Hypoglycemia
Intervention Description
Participants will receive exposure and response prevention and/or hypoglycemia awareness training.
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Other Intervention Name(s)
Standard of Care
Intervention Description
Treatment As Usual
Primary Outcome Measure Information:
Title
Decrease in scores on the Hypoglycemia Fear Survey
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Driscoll, Ph.D.
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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