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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.