Efficacy and safety of hybrid closed-loop systems in children aged < 7 years with type 1 diabetes: a systematic review and meta-analysis of randomized controlled trials.

Abstract

This study aimed to evaluate the clinical efficacy and safety of hybrid closed-loop systems for glycemic control in children aged &lt; 7 years with Type 1 diabetes. Relevant studies published up to July 30, 2025 were electronically retrieved from the PubMed, Cochrane Library, Embase, and Web of Science databases. Two investigators independently screened the literature, extracted valid data, and assessed the risk of bias of included studies, with a meta-analysis conducted via RevMan 5.4 software. Three randomized controlled trials, with 274 children enrolled, were incorporated into the analysis. The results indicated that 3 months of using the hybrid closed-loop system significantly increased the percentage of time in range (mean difference [MD] = 9.95%, 95% confidence interval [CI] [7.8, 12.09], <i>p</i> &lt; 0.00001) and reduced glycated hemoglobin (MD = -0.51%, 95% CI [-0.64, -0.37], <i>p</i> &lt; 0.00001). However, no significant difference was noted in the percentage of time below range between the two groups (MD = 0.56%, 95% CI [-0.13, 1.25], <i>p</i> = 0.11). A comparison of serious adverse events showed no statistically significant differences in the risk of diabetic ketoacidosis (<i>p</i> = 0.50) and severe hypoglycemia (<i>p</i> = 0.64) between the hybrid closed-loop system group and the conventional therapy group. The hybrid closed-loop system can effectively improve glycemic control in children under 7 years old with Type 1 diabetes without increasing the risk of adverse events. Further high-quality, large-sample clinical studies are still required to verify and supplement the present conclusions.