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Positive Impact of the Bionic Pancreas on Diabetes Control in Youth 6-17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial. Diabetes technology & therapeutics Messer, L. H., Buckingham, B. A., Cogen, F., Daniels, M., Forlenza, G., Jafri, R. Z., Mauras, N., Muir, A., Wadwa, R. P., White, P. C., Russell, S. J., Damiano, E. R., El-Khatib, F. H., Ruedy, K. J., Balliro, C. A., Li, Z., Marak, M. C., Calhoun, P., Beck, R. W. 2022; 24 (10): 712-725

Abstract

Objective: To evaluate the insulin-only configuration of the iLet® 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?180?mg/dL, time >250?mg/dL, and standard deviation of CGM glucose favored BP (P?

View details for DOI 10.1089/dia.2022.0201.pub

View details for PubMedID 36173237