A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes
FREE
1 other identifier
interventional
10
1 country
1
Brief Summary
This study is being conducted to determine the feasibility of a cognitive behavioral therapy intervention to reduce fear of hypoglycemia and improve glucose levels in young adults with type 1 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2016
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
October 26, 2016
CompletedFirst Submitted
Initial submission to the registry
May 22, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2018
CompletedResults Posted
Study results publicly available
February 3, 2025
CompletedFebruary 3, 2025
January 1, 2025
1.2 years
May 22, 2017
September 13, 2024
January 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypoglycemia Fear Scale Score (HFS_2)
A reliable and valid psychological scale. It is a 5-point Likert scale \[0-4\], that is summed for a single total continuous scale score. Scores may range from 0-72. Higher numbers indicate greater fear of hypoglycemia.
12 weeks
Secondary Outcomes (3)
Diabetes Self-Management Questionnaire Scale Score (DSMQ)
12 weeks
Glycemic Control, the Average Blood Glucose Over a 2-3 Month Period of Time.
12 weeks
Glycemic Variability
8 weeks
Study Arms (2)
FREE Group
EXPERIMENTALCognitive behavioral therapy intervention with real-time continuous glucose monitoring.
Control Group
NO INTERVENTIONReal-time continuous glucose monitoring
Interventions
Cognitive behavioral therapy with real-time continuous glucose monitoring.
Eligibility Criteria
You may qualify if:
- type 1 diabetes ≥ 1 year
- receive medical care from an endocrinologist
- use insulin pump therapy
- have self-reported fear of hypoglycemia (FOH;screening questionnaire)
You may not qualify if:
- pregnant or breastfeeding
- actively treated for a mental health condition
- have a co-existing chronic illness or taking medications (excluding insulin) that may influence diabetes self-management or glycemic variability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Results Point of Contact
- Title
- Pamela Martyn-Nemeth, Professor
- Organization
- University of Illinois Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Pamela Martyn-Nemeth, PhD
Assistant Professor
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 22, 2017
First Posted
May 24, 2017
Study Start
October 26, 2016
Primary Completion
January 16, 2018
Study Completion
January 16, 2018
Last Updated
February 3, 2025
Results First Posted
February 3, 2025
Record last verified: 2025-01