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

Objective: To evaluate the insulin-only configuration of the iLet((R)) bionic pancreas (BP) in youth 6-17 years old with type 1 diabetes (T1D). Research Design and Methods: 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 (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. Results: 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 (TIR) 70-180mg/dL increased by 10% (2.4h per day) and mean CGM glucose was reduced by 15mg/dL with BP compared with SC (P<0.001). Analyses of time >180mg/dL, time >250mg/dL, and standard deviation of CGM glucose favored BP (P<0.001). Time <54mg/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. Conclusions: 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.

Automated summary

In youth with type 1 diabetes aged 6-17, the insulin-only configuration of the iLet bionic pancreas improved HbA1c levels, time in range, and hyperglycemic metrics without increasing the risk of hypoglycemia compared to standard care. The improvements were most pronounced in participants with higher baseline HbA1c levels.