N/A
N=10
A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes
Type1diabetes
Bottom Line
View on ClinicalTrials.gov: NCT03165786 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Hypoglycemia Fear Scale Score (HFS_2) — 21.4; 38.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FREE (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hypoglycemia Fear Scale Score (HFS_2) |
21.4; 38.6 | — |
| SECONDARY Diabetes Self-Management Questionnaire Scale Score (DSMQ) |
58.7; 50.6 | — |
| SECONDARY Glycemic Control, the Average Blood Glucose Over a 2-3 Month Period of Time. |
6.94; 7.66 | — |
| SECONDARY Glycemic Variability |
73.0; 73.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- type 1 diabetes ≥ 1 year
- receive medical care from an endocrinologist
- use insulin pump therapy
- have self-reported fear of hypoglycemia (FOH;screening questionnaire)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03165786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.