학술논문
Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes.
Document Type
article
Author
Russell, Steven; Beck, Roy; Damiano, Edward; El-Khatib, Firas; Ruedy, Katrina; Balliro, Courtney; Li, Zoey; Calhoun, Peter; Wadwa, R; Buckingham, Bruce; Zhou, Keren; Daniels, Mark; Raskin, Philip; White, Perrin; Lynch, Jane; Pettus, Jeremy; Hirsch, Irl; Goland, Robin; Buse, John; Kruger, Davida; Mauras, Nelly; Muir, Andrew; McGill, Janet; Cogen, Fran; Weissberg-Benchell, Jill; Sherwood, Jordan; Castellanos, Luz; Hillard, Mallory; Tuffaha, Marwa; Putman, Melissa; Sands, Mollie; Forlenza, Gregory; Slover, Robert; Messer, Laurel; Cobry, Erin; Shah, Viral; Polsky, Sarit; Lal, Rayhan; Ekhlaspour, Laya; Hughes, Michael; Basina, Marina; Hatipoglu, Betul; Olansky, Leann; Bhangoo, Amrit; Forghani, Nikta; Kashmiri, Himala; Sutton, Francoise; Choudhary, Abha; Penn, Jimmy; Jafri, Rabab; Rayas, Maria; Escaname, Elia; Kerr, Catherine; Favela-Prezas, Ruby; Trikudanathan, Subbulaxmi; Williams, Kristen; Leibel, Natasha; Kirkman, M; Bergamo, Kate; Klein, Klara; Dostou, Jean; Machineni, Sriram; Young, Laura; Diner, Jamie; Bhan, Arti; Jones, J; Benson, Matthew; Bird, Keisha; Englert, Kimberly; Permuy, Joe; Cossen, Kristina; Felner, Eric; Salam, Maamoun; Silverstein, Julie; Adamson, Samantha; Cedeno, Andrea; Meighan, Seema; Dauber, Andrew; Boeder, Schafer
Source
The New England Journal of Medicine. 387(13)
Subject
Language
Abstract
BACKGROUND: Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS: In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS: A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P