Efficacy of Automated Insulin Delivery Systems in Pediatric Type 1 Diabetes: A Systematic Review of Randomized Controlled Trials

Abstract

Automated insulin delivery (AID) systems couple continuous glucose monitoring with an algorithm that modulates subcutaneous insulin in real time. The efficacy of these systems in children and adolescents-whose management is complicated by variable insulin requirements, unpredictable food intake, and caregiver dependence-warrants dedicated synthesis. We systematically searched PubMed/MEDLINE, Embase, Cochrane CENTRAL, Web of Science, and ClinicalTrials.gov to June 30, 2026, for randomized controlled trials comparing AID with non-automated insulin therapy in participants aged 18 years or younger with type 1 diabetes. The protocol specified that, if more than 10 eligible trials were identified, inclusion would be restricted to reports published on or after January 1, 2020; this criterion was subsequently applied. Two reviewers independently screened records, extracted data, and assessed risk of bias using the Cochrane RoB 2 tool. Findings were synthesized narratively without meta-analysis. Ten trials involving 888 children and adolescents aged 1-18 years met the inclusion criteria. Where time in range was the primary endpoint, AID conferred between-group increases of 8.7 to 12.4 percentage points, equivalent to roughly two to three additional hours in target range daily, with the largest effect observed in children aged 2 to under 6 years. Where HbA1c was the primary endpoint, reductions of 0.32% to 0.5% favored AID, with the greatest absolute benefit among participants furthest from target. Hypoglycemia exposure was not increased. Larger glycemic effects were observed in trials reporting higher device engagement, although this was a between-study observation that was not formally tested. Two trials found no evidence that AID preserved residual beta-cell function, whereas one pilot trial reported more neurotypical brain development with closed-loop therapy. Seven trials were at low risk of bias overall, and three raised some concerns. AID consistently improves glycemic control without increasing hypoglycemia across the pediatric age spectrum, including preschool children. Sustained engagement, equitable access, and longer-term outcomes remain the principal unresolved issues.