A RANDOMIZED STUDY OF THE GLUNOVO REAL-TIME CGM EFFECTIVENESS ON METABOLIC CONTROL IN PATIENTS WITH T2D

Objective: This study aimed to evaluate the effectiveness of the real-time continuous glucose monitoring (RT-CGM) system, Glunovo, in improving glycemic control and patient outcomes in individuals with poorly controlled type 2 diabetes (T2D) compared to traditional self-monitoring of blood glucose (SMBG). Research Design and Methods: This prospective, open-label, randomized controlled trial included 178 patients with T2D from the Fatebenefratelli-Sacco Hospital in Milan. Participants were randomized into 2 groups: 89 patients received the Glunovo RT-CGM (case group), while 89 continued SMBG with standard glucometers (control group). The primary outcome was the change in HbA1c levels after 6 months. Secondary outcomes included time in range (TIR), time above range (TAR), time below range (TBR), mean glucose levels, Glucose Management Indicator GMI and patient satisfaction and well-being assessed by a numeric scale and the WHO-5 Well-Being Scale. Results: After 6 months, the RT-CGM group showed a significant reduction in HbA1c levels (Δ -1.4%, p<0.001), compared to the control group (Δ -0.6% p<0.001). TIR significantly increased in the RT-CGM group (Δ +18.4%, p<0.001). TAR significantly decreased in the RT-CGM group (Δ -17.2%, p<0.001). There was no significant change in TBR in RT-CMG group. The GMI in the RT-CGM group dropped by 1.4% (p<0.001). Satisfaction with the RT-CGM significantly increased (p<0.001), but no significant improvements were observed in the well-being (WHO-5 index). Conclusions: The use of the Glunovo RT-CGM system significantly improved glycemic control and patient satisfaction compared to SMBG. These findings suggest that Glunovo RT-CGM is an effective tool for managing poorly controlled T2D, providing a valuable option for enhancing both glucose regulation and patient self-management through improved dietary awareness and optimized therapy adherence.