Real-World Clinical Outcomes Following Initiation of the iLet® Bionic Pancreas in Youth with Type 1 Diabetes

Background: The iLet ® Bionic Pancreas replaces carbohydrate counting and manual bolus calculations with simplified qualitative meal announcements. Its performance among diverse patients with high baseline glycated hemoglobin (HbA1c) is not well characterized. Methods: Retrospective, single-center cohort study of 71 patients aged 6–21 years with type 1 diabetes (T1D) who initiated the iLet Bionic Pancreas (2023–2025). Primary outcomes were changes in HbA1c and time in range (TIR; 70–180 mg/dL [3.9–10.0 mmol/L]) from baseline to 3 months. Secondary outcomes included glycemic metrics through 12 months, hypoglycemia, and meal-announcement behavior. Results: Mean age was 13.2 ± 3.5 years; 40.8% Black and 38.0% Medicaid-insured. Baseline HbA1c was 9.4 ± 2.1% (79 ± 23 mmol/mol) and TIR was 30.1 ± 19.0%. At 3 months, HbA1c decreased by 1.8 ± 1.7% (−20 ± 19 mmol/mol) and TIR increased by 22.4 ± 22.5 percentage points (both P < 0.0001) without increased hypoglycemia. Improvements were greatest among participants with baseline HbA1c ≥ 9.5% (≥80 mmol/mol) (ΔHbA1c = −3.0% [−32 mmol/mol]; ΔTIR = +31.2 percentage points). Among participants with paired 12-month data, HbA1c decreased from 9.6%–7.6% and TIR increased from 27.7 to 55.8% (both P < 0.0001). Mean meal announcements were 2.9/d at 3 months and 2.1/d at 12 months ( P = 0.722) and were not associated with HbA1c or TIR at 3 months. Conclusions: In this real-world pediatric cohort, iLet initiation was associated with substantial glycemic improvement without increased hypoglycemia, particularly among participants with high baseline HbA1c. Favorable outcomes were observed among participants contributing paired 12-month data.