1878-P: Real-World Effectiveness and Safety of an Open-Source Automated Insulin Delivery System in Very Young Children with Type 1 Diabetes

Introduction and Objective: Open-source automated insulin delivery (OS-AID) systems offer an effective alternative in areas with limited access to AID systems, yet evidence regarding their safety and effectiveness in very young children with type 1 diabetes (T1D) remains scarce. This study evaluated the real-world safety and effectiveness of Android artificial pancreas (AAPS), a widely used OS-AID system, in Chinese children with T1D aged under 7 years. Methods: Demographic and glycemic data from T1D children aged <7 years who had utilized AAPS for at least 3 months were collected between January 2023 and December 2025. Intensive Telehealth Support was provided during the first month. Follow-up assessments were conducted at 3, 6, and 12 months. Glycemic outcomes were analyzed at baseline and longitudinally for up to 12 months. Results: Sixty children were included into analysis (age: 5.5 ± 2.0 years; diabetes duration: 3.2 [0.9, 21.2] months). Available data showed that 73.5% of primary caregivers were mothers, 79.4% held a university degree or higher, and 81.8% reported the annual household income > $4,100. At month 1, time in automation was 90.0 (79.9, 94.3) %. Time in range (70-180 mg/dL, TIR) and time in tight range (70-140 mg/dL, TITR) was 80.4 ± 10.4% and 60.5 ± 13.6%, with 88.3% and 78.3% achieving TIR >70% and TITR>50%. Time above range (TAR) was reported at 14.9 ± 9.3%, while time below range (TBR) was reported at 0.6 ± 0.8% for TBR <54 mg/dL and 4.7 ± 3.3% for TBR <70 mg/dL. Over 3, 6, and 12 months, time in automation and glycemic outcomes remained stable among available data, with no significant differences in TIR (M3: 79.6%, M6: 79.4%, M12: 79.1%), TITR (M3: 61.0%, M6: 59.6%, M12: 58.1%), or TBR70 (M3: 5.2%, M6: 5.3%, M12: 4.1%) between month 1 and month 12 (all P > 0.05). Conclusion: OS-AID system demonstrated reassuring safety and high effectiveness in very young children with T1D. It effectively optimized glycemic control while minimizing hypoglycemia, underscoring it as a therapeutic option to bridge gaps in diabetes technology access. Disclosure Y. Ni: None. Y. Zhou: None. Z. Lin: None. Q. Lin: None. D. Yang: None. H. Deng: None. X. Yang: None. W. Xu: None. J. Yan: None. Funding Noncommunicable Chronic Diseases-National Science and Technology Major Project (2023ZD0508200, 2023ZD0508203)