Extended Use of Automated Insulin Delivery in Young People with Type 1 Diabetes and Elevated HbA1c: 52-Week Outcomes of the CO-PILOT Trial.

Abstract

Aims: To assess longer term outcomes of automated insulin delivery (AID) in young people (7-25 years) with type 1 diabetes (T1D) and baseline glycated hemoglobin (HbA1c) ≥ 69 mmol/mol (8.5%).

Methods: This 52-week, multicenter trial followed 74 participants through an initial 13-week randomized controlled trial comparing AID (MiniMed™ 780G [MM780G]) with standard care (multiple daily injections or continuous subcutaneous insulin infusion) and a 39-week continuation phase where all participants used AID. Due to differing AID exposure times, pooled data are presented for 39 weeks, with 52-week data reflecting extended follow-up for the "AID first" group. Outcomes included HbA1c, continuous glucose monitoring metrics, safety, system performance, and psychosocial measures.

Results: Baseline mean (± standard deviation) HbA1c for all participants (n = 74) was 92 ± 20 mmol/mol (10.5 ± 1.9%). At 52 weeks, the mean HbA1c for the "AID first" group (n = 34) was 67 ± 18 mmol/mol (8.3 ± 1.6%), consistent with the 39-week value for all participants (67 ± 12 mmol/mol [8.3 ± 1.1%]). This followed an initial rapid decrease (mean change: -28 [95% confidence interval (CI): -33, -23] mmol/mol or -2.5 [95% CI: -3.0, -2.1] percentage points at 13 weeks post-AID) and stabilized from 26 weeks in the whole sample. Baseline mean time in range (TIR; 3.9-10 mmol/L) for all available participants (n = 68) was 23.1 ± 13.4%. Following substantial improvement and stabilization with AID use, the mean TIR for the "AID first" group (n = 32) was 63.1 ± 13.7% at 52 weeks. Compared with the 52 weeks before the trial, the diabetic ketoacidosis rate decreased substantially (mean difference: -35.7 events per 100 participant-years), and no severe hypoglycemia occurred. Improved treatment satisfaction and reduced fear of hypoglycemia were reported at 52 weeks.

Conclusion: In young people with T1D and markedly elevated glycemia, longer term AID use with MM780G provided substantial, sustained improvements in glycemia without compromising safety. These findings support broader AID adoption in this high-risk population (Australian New Zealand Clinical Trials Registry number ACTRN12622001454763).