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

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.

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