A Randomized Study of the Glunovo Real-time CGM Effectiveness in Individuals With Poorly Controlled Type 2 Diabetes

Objective: We aim to evaluate the effectiveness of the novel real-time continuous glucose monitoring (rtCGM) system “Glunovo” in improving glycemic control and patient outcomes in individuals with poorly controlled type 2 diabetes (T2D). Research Design and Methods: This prospective, open-label, randomized controlled trial included 172 patients with T2D from the Fatebenefratelli-Sacco Hospital in Milan. Participants were randomized into 2 groups: 86 patients received the Glunovo rtCGM system (case group), whereas 86 continued standard self-monitoring blood glucose with glucometers (control group). The primary outcome was the change in hemoglobin A1c levels after 6 months. Secondary outcomes included glucose metrics and patient well-being assessed by the World Health Organization-5 Well-Being Scale. Results: After 6 months, the Glunovo group showed a significantly higher reduction in hemoglobin A1c levels (Δ = -1.4%) compared to the control group (Δ = -0.6%). Time in range significantly increased in the rtCGM group (Δ = +18.4%). Time above range and glucose management indicator showed a greater reduction in the rtCGM group, with no changes in the time below range. Patient satisfaction increased significantly over the study period with the rtCGM system. Conclusion: The use of the Glunovo rtCGM system significantly improved glycemic control and patient satisfaction compared to self-monitoring blood glucose. These findings suggest that the Glunovo rtCGM is an effective tool for managing poorly controlled T2D.