A Multicenter Randomized Trial Evaluating Fast-Acting Insulin Aspart in the Bionic Pancreas in Adults with Type 1 Diabetes

作者：Roy W. Beck, Steven J. Russell, Edward R. Damiano, Firas H. El-Khatib, Katrina J. Ruedy, COURTNEY A. BALLIRO, Zoey Li, Peter Calhoun · 发表于：Diabetes Technology & Therapeutics · 年份：2022 · DOI：10.1089/dia.2022.0167 · 被引用次数：40 · 研究领域：Diabetes Management and Research、Pancreatic function and diabetes、Diabetes Treatment and Management

Objective: To evaluate the insulin-only configuration of the iLet ® bionic pancreas (BP) using fast-acting insulin aspart (Fiasp ® ) in adults with type 1 diabetes (T1D). Research Design and Methods: In this multicenter, randomized trial, 275 adults with T1D (18–83 years old, baseline HbA1c 5.3%–14.9%) were randomly assigned 2:2:1 to use the BP with fast-acting insulin aspart (BP-F group, N = 114), BP with aspart or lispro (BP-A/L group, N = 107), or a control group using their standard-care insulin delivery (SC group, N = 54) plus real-time continuous glucose monitoring (CGM). The primary outcome was HbA1c at 13 weeks. The BP-F versus SC comparison was considered primary and BP-F versus BP-A/L secondary. Results: Mean ± standard deviation (SD) HbA1c decreased from 7.8% ± 1.2% at baseline to 7.1% ± 0.6% at 13 weeks with BP-F versus 7.6% ± 1.2% to 7.5% ± 0.9% with SC (adjusted difference = −0.5%, 95% CI −0.7 to −0.3, P < 0.001). CGM-measured percent time <54 mg/dL over 13 weeks with BP-F was noninferior to SC (adjusted difference = 0.00%, 95% CI −0.07 to 0.05, P < 0.001 for noninferiority based on a prespecified noninferiority limit of 1%). Over 13 weeks, mean time in range 70–180 mg/dL (TIR) increased by 14% (3.4 h/day) and mean CGM glucose was reduced by 18 mg/dL with BP-F compared with SC ( P < 0.001). Analyses of time >180 mg/dL, time >250 mg/dL, and the SD of CGM glucose all favored BP-F compared with SC ( P < 0.001). Differences between BP-F and BP-A...