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 TITR50%. 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)
NI et al. (Fri,) studied this question.