One-Year Real-World Effectiveness of a Tubeless Automated Insulin Delivery System in Young Adults with Type 1 Diabetes
Giordano Spacco, Silvia Marcenaro, Benedetta Caporotondi, Chiara Rosmino, Barbara Vanorio, Giulia Siri, Maria Grazia Calevo, Alberto Gaiero, Mohamad Maghnie, Nicola Minuto, Marta BassiBackground/Objectives: Omnipod 5 is a tubeless automated insulin delivery system integrating continuous glucose monitoring (CGM) with algorithm-driven insulin delivery. Clinical trials and real-world studies have shown improved glycemic control and reduced hypoglycemia in people with type 1 diabetes (T1D) previously treated with multiple daily injections (MDI) or non-automated sensor-augmented pump (SAP) therapy. However, long-term real-world data in young adults remain limited. Methods: We conducted a retrospective, single-centre observational study including adults with T1D who started therapy with a tubeless automated insulin delivery system (Omnipod 5). Participants were previously treated with MDI or SAP therapy. Glycemic outcomes were assessed using CGM metrics at baseline, 1, 3, and 12 months after starting the system. The primary outcome was change in time in range of 70–180 mg/dL (TIR) at 12 months. Secondary outcomes included additional CGM metrics, insulin therapy parameters, and the occurrence of diabetic ketoacidosis (DKA) and severe hypoglycaemia (SH) episodes. Results: Fifty-two patients were included (mean age 23.0 ± 4.3 years; diabetes duration 13.8 ± 5.9 years); 51 completed 12-month follow-up. At 12 months, TIR increased from 56.1 ± 11.4% to 67.4 ± 11.0% (+11.3%; p < 0.001), while time in tight range of 70–140 mg/dL (TITR) increased from 34.5 ± 10.9% to 44.8 ± 8.7% (+10.3%; p < 0.001). Time in hypoglycemia also decreased, with no episodes of DKA or SH reported during the study period. Glycemic improvements were evident at 1 month and maintained at 12 months. The proportion of patients achieving recommended targets improved at 12 months, including TIR > 70% (13.5% to 43.1%). Total daily insulin requirements remained unchanged, while basal insulin proportion increased, and daily boluses decreased (both p < 0.001). Conclusions: In this real-world study, Omnipod 5 therapy was associated with improved glycemic control and reduced hypoglycemia over 12 months in young adults with T1D, without increasing insulin requirements.