FREE: A randomized controlled feasibility trial of a cognitive behavioral therapy and technology-assisted intervention to reduce fear of hypoglycemia in young adults with type 1 diabetes brief heading: CBT intervention (FREE) to reduce fear of hypoglycemia

Objective The purpose of this study was to test the preliminary effectiveness of a cognitive behavioral therapy intervention (Fear Reduction Efficacy Evaluation [FREE]) designed to reduce fear of hypoglycemia in young adults with type 1 diabetes. The primary outcome was fear of hypoglycemia, secondary outcomes were A1C, and glycemic variability. Methods A randomized clinical trial was used to test an 8-week intervention (FREE) compared to an attention control (diabetes education) in 50 young adults with type 1 diabetes who experienced fear of hypoglycemia at baseline. All participants wore a continuous glucose monitor for the 8-week study period. Self-reported fear of hypoglycemia point-of-care A1C testing, continuous glucose monitor-derived glucose variability were measured at baseline, Week 8, and Week 12 (post-program). Results Compared to controls, those participating in the FREE intervention experienced a reduction in fear of hypoglycemia (SMD B = −8.52, p = 0.021), change in A1C (SMD B = 0.04, p = 0.841) and glycemic variability (glucose standard deviation SMD B = −2.5, p = 0.545) by the end of the intervention. This represented an 8.52% greater reduction in fear of hypoglycemia. Conclusion A cognitive behavioral therapy intervention (FREE) resulted in improvements in fear of hypoglycemia.Clinicaltrials.gov NCT03549104