One-year effectiveness and safety in young children aged 2-6 years with type 1 diabetes using an automated insulin delivery system: A real-world prospective cohort study.

AIMS: This study evaluated 1-year real-world changes in glycaemic management, parent-reported outcomes and safety with an automated insulin delivery (AID) system in young children with type 1 diabetes (T1D). MATERIALS AND METHODS: Children aged 2-6 years whose parents agreed to initiate the Medtronic MiniMed™ 780G were enrolled at 15 centres between October 2022 and December 2023. Data were collected quarterly over 1 year during routine follow-up. Parent-reported outcomes were assessed using questionnaires (HAPPI-D [part of the HAPPI-D Protocol; Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes] and Hypoglycaemia Fear Survey [HFS]-Parent). The primary endpoint was the evolution of time in range (TIR, 70-180 mg/dL) from start to 12 months after start. Data are reported as mean ± SD or least-squares mean (95% confidence interval). RESULTS: A total of 149 children were included (mean age 4.2 ± 1.4 years; 56.4% girls). Mean T1D duration was 22.0 ± 13.0 months and 75.2% used an insulin pump before. After 1 year, TIR increased from 56.8% (54.4-59.2) to 66.6% (64.7-68.5) and haemoglobin A1c decreased from 7.6% (7.4-7.8) to 7.2% (7.1-7.4) (all p < 0.001). Time <70 mg/dL remained stable (5.0% [4.2-5.8] at start vs. 4.6% [3.9-5.3] at 12 months, p = 0.172). Parents reported less diabetes burden on the HAPPI-D (22.9 points [21.7-24.0] at start vs. 21.7 points [20.5-22.8] at 12 months, p = 0.001), while scores on the HFS-Parent did not change significantly. There were no hospitalisations for severe hypoglycaemic events and one for diabetic ketoacidosis due to infusion set occlusion. CONCLUSIONS: One-year use of an AID system in young children with T1D was safe and associated with improved glycaemic management and reduced parental burden, with limited impact on time in hypoglycaemia and related parental fear.