N/A
Completed N=50
A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes
Source: ClinicalTrials.gov NCT03549104 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: Fear of Hypoglycemia — 54.3; 58.7; 35.29; 49.0 units on a scale
Summary
All persons with type 1 diabetes are at risk for developing hypoglycemia (low blood sugar). This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life. Fear of hypoglycemia results in glucose fluctuations (from high to low glucose levels). Young adults are particularly at risk because they report high levels of fear of hypoglycemia and poor glucose control. Currently, no diabetes self-management programs specifically address how to cope with fear of hypoglycemia. The investigators propose to pilot test a fear reduction intervention (Fear Reduction Efficacy Evaluation [FREE]) and its effects on fear of hypoglycemia, diabetes self-management, glucose control, and glucose variability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fear of Hypoglycemia |
54.3; 58.7; 35.29; 49.0 | — |
| SECONDARY Glycemic Control |
7.25; 7.07; 6.68; 6.69 | — |
| SECONDARY Glycemic Variability |
57.8; 56.2; 54.9; 55.5 | — |
Eligibility Criteria
Inclusion Criteria
Diagnosis of T1DM ≥ 1 year, receive medical care from an endocrinologist, use insulin pump therapy or multiple daily injection (MDI), have fear of hypoglycemia (screening questionnaire), and attended a basic diabetes educational program
Exclusion Criteria
Pregnant or breastfeeding, have received therapy specifically for fear of hypoglycemia, have a co-existing chronic illness
Data sourced from ClinicalTrials.gov (NCT03549104). 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. Informational only — not medical advice.