2108-P: Efficacy and Safety of Automated Insulin Delivery System in Very Young Children with Type 1 Diabetes: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Introduction and Objective: To evaluate the efficacy and safety of automated insulin delivery (AID) systems in very young children with Type 1 Diabetes (T1D). Methods: PubMed, Embase, Scopus and Web of Science were searched until October 10th, 2025. Inclusion criteria were randomized controlled trials (RCTs); T1D populations under 7 years old; comparing AID systems with standard care (SC). Primary efficacy endpoint was the percentage of time-in-range of 70-180 mg/dL (TIR) derived from continuous glucose monitoring (CGM), secondary outcomes included glycated hemoglobin (HbA1c), other CGM metrics, and insulin dose. Safety endpoints included severe hypoglycemia (SH) and diabetic ketoacidosis (DKA). Results: Four RCTs involving 292 participants were included. The mean age was 4.70 years, with a mean T1D duration of 1.96 years. The studies duration ranged from 8 to 16 weeks. Compared to SC, AID significantly improved TIR by mean difference(MD) +9.29% (95% confidence interval[CI]: 7.27 to 11.30, I 2 =70%, P<0.001) accompanied by a favorable effect on HbA1c by MD -4 mmol/mol (-0.39%) (95% CI: [-6 to -2] (-0.57 to -0.21), I 2 =82%, P<0.001). Favorable decrease in time-above-range (TAR, >180mg/dL; >250mg/dL) and mean blood glucose were also observed in AID over SC (all P<0.05). No significant differences were observed between AID and SC groups in time in hypoglycemia, insulin dose, and risk of SH and DKA (all P>0.05). Conclusion: AID systems outperformed SC in improving overall glucose control represented by TIR, HbA1c and TAR in very young children with T1D, without increasing time in hypoglycemia, insulin dose and risk of SH and DKA. Disclosure Q. Lin: None. Y. Zhou: None. M. Lei: None. P. Ling: None. Y. Ni: None. Z. Lin: None. D. Yang: None. W. Xu: None. H. Deng: None. J. Yan: None. Funding Noncommunicable Chronic Diseases-National Science and Technology Major Project (2023ZD0508200, 2023ZD0508203), National Natural Science Foundation of China (82501081)