Cost‐effectiveness analysis of real‐time continuous monitoring glucose compared to self‐monitoring of blood glucose for diabetes mellitus in Spain.

Abstract: Rationale, aims and objectives: Self‐monitoring of blood glucose (SMBG) is recommended to monitor glycaemic levels. The recent development of real‐time continuous glucose monitoring (RT‐CGM) enables continuous display of glucose concentration alerting patients in the event of relevant glucose fluctuations, potentially avoiding hypoglycaemic events and reducing long‐term complications related to glycosylated haemoglobin (HbA1c) levels. This paper aims to evaluate the cost‐effectiveness of RT‐CGM compared to SMBG in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) which should support decision‐making on public funding of RT‐CGM in Spain. Methods: We performed a systematic review and meta‐analyses on the effectiveness of RT‐CGM in the reduction of HbA1c levels and severe hypoglycaemic events. A cost‐effectiveness analysis was conducted using a Markov model which simulates the costs and health outcomes of individuals treated under these alternatives for a lifetime horizon from the perspective of the Spanish Health Service. The effectiveness measure was quality‐adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis. Results: Real‐time continuous glucose monitoring provides a significant reduction of HbA1c for T1DM (13 studies; weighted mean difference (WMD) = −0.23%, 95% CI: −0.35, −0.11) and T2DM (5 studies; WMD = −0.48%, 95% CI: −0.79, −0.17). There were no statistically significant differences in the rate of severe hypoglycaemic events in T1DM (9 studies; OR = 1.16, 95% CI: 0.78, 1.72) or T2DM (no severe hypoglycaemic events were reported in any study). In the base case analysis, RT‐CGM led to higher QALYs and health care costs with an estimated incremental cost‐effectiveness ratio of €2 554 723 and €180 553 per QALY for T1DM and T2DM patients respectively. Sensitivity analyses revealed that the study results were robust. Conclusions: Real‐time continuous glucose monitoring is not a cost‐effective technology when compared to SMBG in Spain. [ABSTRACT FROM AUTHOR]