Abstract

To evaluate the insulin-only configuration of the iLet® bionic pancreas (BP) in youth 6-17 years old with type 1 diabetes (T1D).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 prior to the study) were randomly assigned 2:1 to use the BP (N=112) with insulin aspart or insulin lispro (BP group) or to a control group (N=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.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%, P<0.001). Participants with baseline HbA1c =9.0% (N=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 70-180 mg/dL (TIR) increased by 10% (2.4 hours per day) and mean CGM glucose was reduced by 15 mg/dL with BP compared with SC (P<0.001). Analyses of time >180 mg/dL, time >250 mg/dL, and standard deviation of CGM glucose all favored BP (P<0.001). Time <54 mg/dL was low at baseline (median 0.2%) and not significantly different between groups over 13 weeks (P=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.In youth 6-17 years old with T1D, use of the insulin-only configuration of the 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.

View details for DOI 10.1089/dia.2022.0201

View details for PubMedID 35763327