- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03039933
Intervention to Reduce Fear of Hypoglycemia and Optimize Type 1 Diabetes Outcomes
September 8, 2021 updated by: University of Colorado, Denver
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- University of Colorado, Denver
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Fear of Hypoglycemia Intervention
Cognitive behavioral therapy based psychological intervention occurring every other week for 12 weeks.
|
Participants will receive exposure and response prevention and/or hypoglycemia awareness training.
|
Other: Treatment As Usual
Control group completes questionnaires but does not receive any study intervention.
Receives medical care as usual.
|
Treatment As Usual
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decrease in scores on the Hypoglycemia Fear Survey
Time Frame: Baseline, 3 and 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kimberly Driscoll, Ph.D., University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
August 1, 2020
Study Completion (Actual)
August 1, 2020
Study Registration Dates
First Submitted
December 19, 2016
First Submitted That Met QC Criteria
January 31, 2017
First Posted (Estimate)
February 1, 2017
Study Record Updates
Last Update Posted (Actual)
September 16, 2021
Last Update Submitted That Met QC Criteria
September 8, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-0645
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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