Efficacy and safety of a tubeless open‐source hybrid automated insulin delivery use at home among adults with type 1 diabetes mellitus: Results from a 26‐week, free‐living, randomized crossover trial

Abstract Aim This study aims to evaluate the efficacy and safety of a tubeless open‐source hybrid automated insulin delivery (OS‐AID) in managing adults with type 1 diabetes mellitus (T1DM) in China, where commercial AID systems are not accessible. Methods In this open‐label randomized crossover study, adults with T1DM aged 18–75 years, glycated haemoglobin (HbA1c) 7%–11% (53‐97 mmol/mol) and who have never used AID previously, were assigned to either Android‐version hybrid OS‐AID (AAPS) or sensor‐augmented insulin pump (SAP) therapy for three months, followed by a crossover to the alternative treatment for an additional three months. The primary endpoint was the percentage of time in range (TIR, 70‐180 mg/dL [3.9–10.0 mmol/L]) during the final two weeks of each treatment phase. Results A total of 28 adults with T1DM, with a mean age of 33.6 ± 10.4 years and a T1DM duration of 12.6 ± 7.0 years, were enrolled in this study. The percentage of TIR (70‐180 mg/dL [3.9–10.0 mmol/L]) during the AAPS phase was 75.6 ± 10.3%, significantly higher than the 60.4 ± 15.1% observed during the SAP phase ( p < 0.01). AAPS was notably more effective in managing nocturnal glucose levels compared to diurnal glucose levels (80.9 ± 13.6% vs. 73.8 ± 10.2%, p < 0.01). No significant differences in time below range were observed between the two phases. No severe hypoglycaemia or serious adverse events occurred in either treatment phase. Conclusion In this 26‐week trial involving adults with T1DM who had never previously used AID, the tubeless AAPS use at home resulted in a significantly higher percentage of time in the target glucose range without increasing hypoglycaemia risk compared to SAP therapy.