Real-world effectiveness of a tubeless AID system in children and adolescents with T1D in Italy: preliminary results of a multicenter study

Introduction: AID systems are currently the most effective therapy for patients with T1D. Real-world studies on the use of tubeless AID systems are still limited in Italy. Objectives: To assess the effectiveness, safety, and user settings of a tubeless automated insulin delivery (AID) system in pediatric patients aged 2–18 years with type 1 diabetes (T1D) previously treated with multiple daily injections (MDI) or sensor-augmented pump (SAP). Methods: This multicenter, prospective, observational study was conducted by the ISPED Diabetes Study Group with a planned 12-month follow-up. Preliminary data analysis was conducted on clinical and glycemic data collected at initiation (T0), and after 1 (T1) and 3 months (T2). A total of 214 patients from 12 Italian centers were included; 180 completed the 1-month and 124 the 3-month visit. Continuous variables were described as mean (SD) or median (IQR); categorical variables as frequencies and percentages. Differences were tested using Wilcoxon signed-rank test; p<0.05 was considered significant. Results: Mean age of participant included in the study was 13.65±3.41 years; 50.5% were female and 95.3% were Caucasian. At baseline, 40.8% were on MDI and 59.2% on SAP. 1-month after the system initiation glycemic control improved significantly, with TIR increasing from 55.87% to 70.79% (+14.92%, p<0.001), TITR from 35.28% to 45.99% (+10.71%, p<0.001), and TBR decreasing from 3.46% to 2.25% (p<0.001). These results were substantially maintained at 3 months (TIR 70.77%±9.7, TITR 46.71%±10.68, TBR 2.03%±2.39), together with a significant reduction in HbA1c (-0.36%, from 7.20±0.75% to 6.84±0.68%, p<0.001) and no significant change in total daily insulin requirement. A single glucose target was set in 84.6% of patients, most frequently 110 mg/dL (61.7%). Conclusions: Preliminary real-world data show that this tubeless AID system is effective and safe, achieving rapid and sustained improvements in glycemic control in Italian pediatric patients with T1D during the first three months of use.