Objective: This study compares unregulated open-source (OS) automated insulin delivery (AID) systems and commercial-AID (C-AID) systems regarding glucose management, patient-reported outcomes (PROs), and safety among adults with type 1 diabetes (T1D). Methods: We conducted a 12-week, prospective, observational, noninferiority, comparative, real-world study involving 78 adults with T1D and having used an AID system for ≥3 months (26 OS-AID and 52 C-AID users). A total of 4-week data from a blinded continuous glucose monitor was used to assess the effectiveness in glucose management (primary outcome: 24 h time in range [TIR%] for 4 weeks, with a noninferiority margin of 5%). Results: Our study suggested that OS-AIDs were noninferior to C-AIDs regarding the 24 h TIR% (78.3% [standard deviation or SD 11.0] vs. 71.2% [SD 10.9], mean difference 7.2% [95.08% confidence interval or CI: 1.9% to 12.5%], P < 0.001), even after adjusting for various confounding factors. OS-AIDs spent more time in hypoglycemia (<3.9 mmol/L) than C-AIDs (3.9% [SD 3.1] vs. 1.8% [SD 1.3], P < 0.001) yet within the recommended range. OS-AID users reported less fear of hypoglycemia, while other PRO measures (diabetes distress, hypoglycemia awareness, sleep, fear of hypoglycemia, treatment satisfaction, and overall quality of life) were not different between groups. No severe hypoglycemia or diabetic ketoacidosis was reported in either group, with a similar occurrence rate of technical issues during the 12-week study period. Conclusions: OS-AIDs are safe and noninferior to C-AIDs for TIR% among adults with T1D in real-world settings. Both OS-AID and C-AID systems can be considered for T1D management.
Keywords: automated insulin delivery system; glucose management; open-source; patient-reported outcome measures; type 1 diabetes.