Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
1 other identifier
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 19, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedSeptember 16, 2021
September 1, 2021
4 years
December 19, 2016
September 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Fear of Hypoglycemia Intervention
ACTIVE COMPARATORCognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks.
Treatment As Usual
OTHERControl group completes questionnaires but does not receive any study intervention. Receives medical care as usual.
Interventions
Participants will receive exposure and response prevention and/or hypoglycemia awareness training.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- developmental disability or reading disorder that prevents understanding of the intervention materials; and
- non-English speaking adolescents and parents.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- University of Virginiacollaborator
Study Sites (1)
University of Colorado, Denver
Aurora, Colorado, 80045, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly Driscoll, Ph.D.
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2016
First Posted
February 1, 2017
Study Start
August 1, 2016
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
September 16, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share