A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults with Type 1 Diabetes
- Principal Investigator
- Martyn-Nemeth, Pamela
- Start Date
- End Date
- Funding Source
- National Institute of Diabetes, Digestive & Kidney Disorders
In persons with type 1 diabetes (T1DM), 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 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 compared to other age groups with T1DM. In our preliminary work, we found that 77% of young adults with T1DM reported FOH; FOH resulted in increased glycemic variability, with greater glycemic variability occurring after FOH. Glycemic variability (GV) is the minute-to-minute fluctuation in blood glucose that can be missed if looking only at A1C. Increased GV is dangerous because it is associated with cardiovascular events and diabetes complications. Cardiovascular disease remains the primary cause of mortality in T1DM, therefore strategies to reduce it are necessary. A major gap exists in how to manage FOH as a component of diabetes self-management. Our overall objective is to reduce FOH and improve diabetes self-management, glycemic control, and GV in young adults with T1DM to reduce or delay diabetes complications and improve quality of life. We 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 CBT-based intervention on the outcomes: FOH, self-management behavior, glycemic control, and GV. To achieve these aims, we propose a randomized controlled trial in 50 young adults aged 18 to 30 years with T1DM. Participants will be screened for FOH levels. Eligible subjects will be randomized to the intervention program (Fear Reduction Efficacy Evaluation [FREE]) or attention control group. A one-week run-in phase is planned, with baseline measures of FOH, self-management behavior 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 individual 1-hour sessions using a CBT and exposure treatment for specific fears. RT-CGM and a daily FOH diary will be used as feedback cues as part of the FREE program. The attention control group will participate in eight weekly individual 1-hour diabetes self-management education (DSME) sessions and wear a 24-hour RT-CGM device (to measure GV only) during the same eight-week period. At completion, FOH will be measured, and RT-CGM recordings will be analyzed to determine differences between the intervention and control group. 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 glycemic variability. This program of research promises to reduce the development of diabetes complications and improve quality of life for young adults with T1DM.