Efficacy and safety of automated insulin delivery system in very young children with type 1 diabetes: A systematic review and meta‐analysis of randomized controlled trials

Abstract Aim 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 10 October 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 haemoglobin (HbA1c), other CGM metrics, and insulin dose. Safety endpoints included severe hypoglycaemia (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 study duration ranged from 8 to 16 weeks. Compared with SC, AID significantly improved TIR by mean difference (MD) +9.29% (95% confidence interval [CI]: 7.27–11.30, I 2 = 70%, p < 0.001) accompanied by a favourable 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). A favourable decrease in time‐above‐range (TAR, >180 mg/dL; >250 mg/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 hypoglycaemia, insulin dose, and risk of SH and DKA (all p > 0.05). Conclusion AID systems may outperform SC in improving short‐term glycaemic control (TIR, HbA1c, TAR) in very young children with T1D, without increasing time in hypoglycaemia, insulin dose, or risk of SH and DKA. These preliminary findings support the clinical potential of AID systems and highlight the need for longer term studies.