Continuous GlucoSe Monitor And SmaRT Insulin Pen SysteM: A Real WorlD LIfe Analysis of Cohort Study

Background: Diabetes affects over 460 million people worldwide and poses a growing public health challenge, driven largely by dietary and lifestyle factors. While type 2 diabetes (T2D) is more prevalent, type 1 diabetes (T1D) presents unique therapeutic challenges, particularly in younger individuals. Advances in diabetes management, such as continuous glucose monitoring (CGM), insulin pumps (IP), and, more recently, smart multiple dose injection (MDI) pens, have significantly enhanced glycemic control and improved patients' quality of life. Aim: This study aims to evaluate the baseline characteristics of patients switching from MDI therapy to the Medtronic Smart MDI system [composed by a smart insulin pen (InPenTM) and a connected CGM Medtronic SimpleraTM sensor] and to assess its impact on glycemic outcomes over different time periods (14, 30, and 90 days). Methods: A retrospective observational study was conducted among adults with T1D who initiated Medtronic Smart MDI therapy. Participants were enrolled voluntarily at the Diabetes and Nutrition Clinic in Ast Fermo, Marche Region, Italy. Glycemic parameters were monitored using CGM data and analyzed with descriptive statistics, including mean, standard deviation (SD), and interquartile range (IQR). Comparisons across time periods were performed using the Wilcoxon signed-rank test, with statistical significance set at p < 0.05. Results: This study involved 21 subjects with a mean age of 51.5 years, a mean BMI of 24.7, and a T1D duration of 21.9 years. After switching from MDI to Medtronic Smart MDI, significant improvements were noted: mean sensor glucose (SG) decreased from 171.0 to 153.5 mg/dL (p = 0.035), Time in Range (TIR) increased from 58.0% to 64.4% (p = 0.005), and a mean Time Above Range (TAR) (>180mg/dL) decreased from 39.0% to 34.2% (p = 0.015). No significant differences were found in Time Below Range (TBR). Conclusion: Transitioning to Medtronic Smart MDI in T1D patients significantly improves glycemic control, notably by reducing average glucose levels and increasing TIR. This integrated approach enhances overall disease management, reducing hyperglycemia while maintaining stable hypoglycemia risk. Further studies are needed to optimize its use in daily practice and long-term care.