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

Abstract 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. Clinical trial registration NCT07089979