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

• DOI: 10.1089/dia.2022.0201.pub
• Publication Date: 2022-09-29T09:09:40Z
• Authors: Laurel H. Messer; Bruce A. Buckingham; Fran Cogen; Mark Daniels; Greg Forlenza; Rabab Z. Jafri; Nelly Mauras; Andrew Muir; R. Paul Wadwa; Perrin C. White; Steven J. Russell; Edward R. Damiano; Firas H. El-Khatib; Katrina J. Ruedy; Courtney A. Balliro; Zoey Li; Martin Chase Marak; Peter Calhoun; Roy W. Beck
• Keywords: Insulin pump; Insulin aspart; Artificial Pancreas; Clinical endpoint

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