A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With Type 1 Diabetes
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

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.
    

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.
    

Intervention name(s): FREE
Intervention type(s): Behavioral
Intervention description(s): Cognitive behavioral therapy with real-time continuous glucose monitoring.
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Other
Keywords: fear of hypoglycemia; self-management; glycemic control; glycemic variability