Positive Impact of the Bionic Pancreas on Diabetes Control in Youth 6–17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial

Abstract

<b><i>Objective:</i></b> To evaluate the insulin-only configuration of the iLet^® bionic pancreas (BP) in youth 6-17 years old with type 1 diabetes (T1D). <b><i>Research Design and Methods:</i></b> In this multicenter, randomized, controlled trial, 165 youth with T1D (6-17 years old; baseline HbA1c 5.8%-12.2%; 35% using multiple daily injections, 36% using an insulin pump without automation, 4% using an insulin pump with low glucose suspend, and 25% using a hybrid closed-loop system before the study) were randomly assigned 2:1 to use BP (<i>n</i> = 112) with insulin aspart or insulin lispro (BP group) or to a control group (<i>n</i> = 53) using their personal standard care insulin delivery (SC group) plus real-time continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. <b><i>Results:</i></b> Mean HbA1c decreased from 8.1% ± 1.2% at baseline to 7.5% ± 0.7% at 13 weeks with BP versus 7.8% ± 1.1% at both baseline and 13 weeks with SC (adjusted difference = -0.5%, 95% CI -0.7% to -0.2%, <i>P</i> < 0.001). Participants with baseline HbA1c ≥9.0% (<i>n</i> = 34) decreased mean HbA1c from 9.7% ± 0.8% to 7.9% ± 0.6% after 13 weeks with BP compared with 9.7% ± 0.5% to 9.8% ± 0.8% with SC. Over 13 weeks, mean time in range (TIR) 70-180 mg/dL increased by 10% (2.4 h per day) and mean CGM glucose was reduced by 15 mg/dL with BP compared with SC (<i>P</i> < 0.001). Analyses of time >180 mg/dL, time >250 mg/dL, and standard deviation of CGM glucose favored BP (<i>P</i> < 0.001). Time <54 mg/dL was low at baseline (median 0.2%) and not significantly different between groups over 13 weeks (<i>P</i> = 0.24). A severe hypoglycemia event occurred in 3 (2.7%) participants in the BP group and in 1 (1.9%) in the SC group. <b><i>Conclusions:</i></b> In youth 6-17 years old with T1D, use of insulin-only configuration of BP improved HbA1c, TIR, and hyperglycemic metrics without increasing CGM-measured hypoglycemia compared with standard of care. Improvement in glycemic metrics was most pronounced in participants with high baseline HbA1c levels. <b><i>Clinical Trial Registry:</i></b> clinicaltrials.gov; NCT04200313.