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A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes

NCT03549104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-06-06

Study results available
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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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BEHAVIORAL

Fear Reduction Intervention

FREE

BEHAVIORAL

Attention Control

DSMES

Sponsors & Collaborators

  • Loyola University Chicago

    collaborator OTHER

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Pamela Martyn-Nemeth, PhD · University of Illinois at Chic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03549104 on ClinicalTrials.gov