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Trial record 10 of 872 for:    hypoglycemia | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT03165786
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Pamela Martyn-Nemeth, University of Illinois at Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type1diabetes Behavioral: FREE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes
Actual Study Start Date : October 26, 2016
Actual Primary Completion Date : January 16, 2018
Actual Study Completion Date : January 16, 2018

Resource links provided by the National Library of Medicine


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 Name: CBT

No Intervention: Control Group
Real-time continuous glucose monitoring



Primary Outcome Measures :
  1. Hypoglycemia Fear Scale Score (HFS_2) [ Time Frame: 12 weeks ]
    reliable and valid psychological scale, provides single scale score


Secondary Outcome Measures :
  1. Diabetes Self-Management Questionnaire Scale Score (DSMQ) [ Time Frame: 12 weeks ]
    reliable and valid behavioral scale, provides single scale score

  2. Glycemic control [ Time Frame: 12 weeks ]
    Hemoglobin A1c

  3. Glycemic variability [ Time Frame: 9 weeks ]
    twenty-four hour fluctuations in glucose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03165786


Locations
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United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Principal Investigator: Pamela Martyn-Nemeth, PhD Assistant Professor

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Responsible Party: Pamela Martyn-Nemeth, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT03165786     History of Changes
Other Study ID Numbers: 2016-0206
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

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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
self-management
glycemic control
glycemic variability

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