Clinical trial NCT03549104: A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes
Official title: A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With T1DM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: fear of hypoglycemia
glycemic control
glycemic variability
self-management behavior
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Loyola University Chicago
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-06-07
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Fear of Hypoglycemia
timeFrame: Assessing change between two time points: from baseline to week 8 of intervention.
Secondary outcomes:
measure: Glycemic Control
timeFrame: Assessing change between two time points: from baseline to week 8 of intervention.
measure: Glycemic Variability
timeFrame: Assessing change between two time points: from baseline to week 8 of intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chic
name: Pamela Martyn-Nemeth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.