What type of study is this?

This is a Systematic Review study.

May 13, 2026

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

Puntos clave

This research evaluates the effectiveness and safety of automated insulin delivery systems in very young children with type 1 diabetes.
Performed a systematic review and meta-analysis of randomized controlled trials (RCTs).
Included studies on children under 7 years with type 1 diabetes comparing automated insulin delivery (AID) to standard care (SC).
Searched PubMed, Embase, Scopus, and Web of Science until October 10, 2025.
AID systems improved time-in-range (TIR) and lowered time-above-range (TAR) metrics compared to standard care.
No significant increases in hypoglycaemia risk, insulin dose, or incidents of diabetic ketoacidosis (DKA) were observed.
Primary efficacy endpoint of TIR was more favorable in the AID group, with significant statistical results (p < 0.05).

Resumen

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: = 82%, p 180 mg/dL; >250 mg/dL) and mean blood glucose were also observed in AID over SC (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.

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