Objective: Real-time continuous glucose monitoring (RT-CGM) provides detailed information on glucose patterns and trends, thus allowing the patients to manage their diabetes more effectively. Design: The aim of this study was to explore the potential beneficial effects of the use of RT-CGM on diabetes management compared with self blood glucose measurement (SBGM) in patients with type 1 diabetes mellitus (T1DM), by means of a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: MEDLINE, EMBASE, and the Cochrane Library were searched through by two independent investigators for RCTs concerning the use of RT-CGM in patients with T1DM. Only studies with a similar insulin regimen in the experimental and control groups were included in the analysis. Results: Seven RCTs (nZ948) met the inclusion criteria. Combined data from all studies showed better HbA1c reduction in subjects using RT-CGM compared with those using SBGM (mean difference (MD) K0.25; 95% confidence interval (95% CI): from K0.34 to K0.17; P!0.001). Patients treated with insulin pump and RT-CGM had a lower HbA1c level compared with subjects managed with insulin pump and SBGM (four RCTs, nZ497; MD K0.26; 95% CI: from K0.43 to K0.10; PZ0.002). The benefits of applying RT-CGM were not associated with an increasing rate of major hypoglycemic episodes. The use of RT-CGM for over 60-70% of time was associated with a significant lowering of HbA1c. Conclusions: RT-CGM is more beneficial than SBGM in reducing HbA1c in patients with type 1 diabetes. Further studies are needed to evaluate the efficacy of this system in the pediatric population, especially in very young children.