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

A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With T1DM

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Fear Reduction Intervention; Behavioral: Attention Control

Detailed Description

In persons with type 1 diabetes (T1DM), hypoglycemia is the major limiting factor in achieving optimal blood glycemic control. All persons with T1DM are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and accompanied by serious physical and psychological symptoms, resulting in a profound fear of hypoglycemia (FOH) and reduced quality of life. Young adults with T1DM are at greater risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1DM. The investigator's preliminary research identified that 77% of young adults with T1DM reported FOH, and FOH resulted in increased glycemic variability. Glycemic variability (GV) is the minute-to-minute fluctuation in blood glucose that can be missed if looking only at A1C, a longer-term measure. Increased GV is dangerous because it is associated with cardiovascular events and diabetes complications. A major gap exists in how to manage FOH as a component of diabetes self-management. The Investigators specifically aim to: (1) determine the feasibility and acceptability of a fear reduction program in young adults with T1DM, who experience FOH; and (2) determine the impact of an 8-week cognitive behavioral therapy (CBT)-based intervention on the outcomes: FOH, self-management behavior, glycemic control, and GV. To achieve these aims, the investigators propose a randomized controlled trial in 50 young adults aged 18 to 35 years with T1DM. At completion, FOH will be measured and glycemic patterns will be analyzed to determine differences between the FREE and control groups. Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to reduce FOH and improve self-management, glycemic control, and GV. This program of research promises to reduce the development of diabetes complications and improve quality of life for young adults with T1DM.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fear Reduction Efficacy Evaluation (FREE); The FREE intervention group will participate in eight weekly individual one-hour sessions using CBT and exposure treatment for specific fears.	Behavioral: Fear Reduction Intervention; FREE
Active Comparator: Attention Control; The attention control group will participate in eight weekly individual one-hour Diabetes Self-Management Education (DSME) sessions.	Behavioral: Attention Control; DSMES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of Hypoglycemia	Change in Worry Subscale score. Fear of hypoglycemia is measured with the Worry Subscale of the Hypoglycemia Fear Survey II (HFS-II) which is an 18-item, 5-point Likert-style scale with a possible score range from 0-72. A higher score indicates greater fear of hypoglycemia.	Assessing change between two time points: from baseline to week 8 of intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Control	Change in HemoglobinA1c (A1C)	Assessing change between two time points: from baseline to week 8 of intervention.
Glycemic Variability	Change in glucose variability (continuous glucose monitor-derived, glucose (mg/dl) standard deviation. Higher numbers indicate worse glycemic variability.	Assessing change between two time points: from baseline to week 8 of intervention

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Loyola University Chicago
• Investigators: Principal Investigator: Pamela Martyn-Nemeth, PhD, University of Illinois at Chic

Publications and helpful links

General Publications

• Martyn-Nemeth P, Duffecy J, Quinn L, Park C, Mihailescu D, Penckofer S. A cognitive behavioral therapy intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes (FREE): study protocol for a randomized controlled trial. Trials. 2019 Dec 30;20(1):796. doi: 10.1186/s13063-019-3876-4.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: June 5, 2018
• First Posted (Actual): June 7, 2018

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: glycemic variability; glycemic control; fear of hypoglycemia; self-management behavior
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: 2018-0382; R21DK116146 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No