A Cognitive Behavioral Therapy (CBT) Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

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.
    

Intervention name(s): Fear Reduction Intervention; Attention Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): FREE; DSMES
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fear of hypoglycemia; glycemic control; glycemic variability; self-management behavior