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

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ClinicalTrials.gov Identifier: NCT03549104
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : July 17, 2019
Sponsor:
Collaborators:
Loyola University Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Pamela Martyn-Nemeth, University of Illinois at Chicago

Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Fear Reduction Intervention Behavioral: Attention Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With T1DM
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Fear of Hypoglycemia [ Time Frame: Assessing change between two time points: from baseline to week 8 of intervention. ]
    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.


Secondary Outcome Measures :
  1. Glycemic Control [ Time Frame: Assessing change between two time points: from baseline to week 8 of intervention. ]
    Change in HemoglobinA1c (A1C)

  2. Glycemic Variability [ Time Frame: Assessing change between two time points: from baseline to week 8 of intervention ]
    Change in glucose variability (continuous glucose monitor-derived)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549104


Contacts
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Contact: Pamela Martyn-Nemeth, PhD 312-996-7903 pmartyn@uic.edu
Contact: Laurie Quinn, PhD 312-996-7906 lquinn1@uic.edu

Locations
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United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Pamela Martyn-Nemeth, PhD    312-996-7903    pmartyn@uic.edu   
Contact: Laurie Quinn, PhD    13129967906    lquinn1@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago
Loyola University Chicago
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Pamela Martyn-Nemeth, PhD University of Illinois at Chic

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Responsible Party: Pamela Martyn-Nemeth, Assistant Professor Biobehavioral Health Science College of Nursing, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03549104     History of Changes
Other Study ID Numbers: 2018-0382
R21DK116146 ( U.S. NIH Grant/Contract )
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pamela Martyn-Nemeth, University of Illinois at Chicago:
fear of hypoglycemia
glycemic control
glycemic variability
self-management behavior

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases