A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes (FREE)

March 27, 2019 updated by: Pamela Martyn-Nemeth, University of Illinois at Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In persons with type 1 diabetes (T1DM), iatrogenic hypoglycemia is the major limiting factor in achieving optimal blood glucose control. All persons with T1DM are at risk for hypoglycemia (blood glucose level < 70 mg/dl), which is life-threatening and has serious physical symptoms and psychological sequelae that lead to profound fear of future hypoglycemic events. This fear results in greater glucose variability (the intra-day fluctuations in blood glucose), due to under- or overcompensation of food intake, insulin dosing, or physical activity, as well as anxiety, depression, and reduced quality of life. Greater glycemic variability (GV) is associated with a higher risk of hypoglycemia and diabetes complications. Young adults are particularly at risk because they report greater FOH and have poorer glycemic control. A major gap exists in how to manage FOH as a crucial component of diabetes self-care. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and variability in young adults with T1DM. We specifically aim to: (1) Determine the feasibility of an 8-week CBT-based intervention to reduce FOH and (2) obtain means and standard deviations of group differences from baseline to program completion on the outcomes of FOH, self-management, glycemic control and glycemic variability in young adults with T1DM who experience FOH. To achieve these aims, we propose a randomized control pilot trial in 10 young adults aged 18 to 30 years with T1DM. Participants will be screened for FOH levels. Eligible subjects will be randomized to the intervention (Fear Reduction Efficacy Evaluation [FREE]) program or attention control group. A 1-week run-in phase is planned, with baseline measures of FOH and 24-hour real-time continuous glucose monitoring recordings (RT-CGM) to calculate GV for both groups. The intervention group will participate in eight weekly one-hour sessions using a cognitive behavioral therapy (CBT) and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues. The control group will wear a 24-hour RT-CGM device during the same 8-week period and return for weekly RT-CGM site changes by study staff. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine within-group and between-group differences. The findings from this proposed study will serve as the foundation for a larger clinical trial to reduce FOH and improve self-management, glycemic control, and variability. Meeting these goals will have important clinical implications to reduce diabetes complications and improve quality of life in young adults with T1DM.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FREE Group
Cognitive behavioral therapy intervention with real-time continuous glucose monitoring.
Behavioral: FREE
Cognitive behavioral therapy with real-time continuous glucose monitoring.
Other Names:
  • CBT
No Intervention: Control Group
Real-time continuous glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemia Fear Scale Score (HFS_2)
Time Frame: 12 weeks
reliable and valid psychological scale, provides single scale score
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diabetes Self-Management Questionnaire Scale Score (DSMQ)
Time Frame: 12 weeks
reliable and valid behavioral scale, provides single scale score
12 weeks
Glycemic control
Time Frame: 12 weeks
Hemoglobin A1c
12 weeks
Glycemic variability
Time Frame: 9 weeks
twenty-four hour fluctuations in glucose
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Pamela Martyn-Nemeth, PhD, Assistant professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2016

Primary Completion (Actual)

January 16, 2018

Study Completion (Actual)

January 16, 2018

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (Actual)

May 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-0206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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