Cost-Effectiveness of Stepped Care compared to Continuous Glucose Monitoring in Hypoglycemia-Prone Individuals with Type 1 Diabetes

Aims To assess the cost-effectiveness of stepped care (education program plus continuous glucose monitoring (CGM) as needed), compared to immediate CGM use. Methods Analyses were conducted from a societal perspective over a 12-month horizon. Data were used from the Ecspect-Hypo randomized clinical trial, including 52 individuals with type 1 diabetes (T1D) and impaired hypoglycemia-awareness or a history of recent severe hypoglycemic events (SHEs) (mean age 53 years; 56% female). Outcomes included self-reported SHEs, quality-adjusted life years (QALYs) based on the EuroQol questionnaire, and costs were assessed using Tic-P questionnaires. Incremental cost-effectiveness ratios (ICERs) were calculated and cost-effectiveness acceptability curves were estimated. Results After 12 months, stepped care resulted in more SHEs (mean difference 0.33, 95%CI 0.056;0.60), less QALYs (mean difference -0.12, 95%CI -0.23;-0.0045), and lower societal costs (mean difference €-252, 95%CI -921;656) compared to CGM. The ICER per prevented SHE was €769, and per QALY gained €5518. The probability that stepped care was cost-effective compared to CGM use was 0.73 at a willingness to pay (WTP) of €0/SHE prevented and per individual with restored hypoglycemia-awareness, and 0.14 at €20,000/QALY gained. Conclusions Over 12 months, at a WTP threshold of €20,000/QALY, stepped care was not cost-effective compared to immediate CGM use in hypoglycemia-prone individuals with T1D.