Boston University announced that the 11-day multi-center home study (n=39) of the bihormonal Bionic Pancreas was published in the prestigious medical journal, The Lancet, on Monday: “Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial.” The article has an impressive 30 authors from the study’s four sites (MGH/BU, UMass, UNC, Stanford), including Drs. Firas El-Khatib, David Harlan, Trang Ly, Bruce Buckingham, John Buse, Ed Damiano, and Steven Russell. Drs. Damiano and Russell have presented these impressive results several times, beginning with GTCBio 2015 last April and more recently at ADA 2016. The study was the team’s first true home-use study, comparing 11 days of Bionic Pancreas to 11 days of conventional pump therapy. Patients wore the iPhone 4S-based research platform with two Tandem t:slim pumps and a Dexcom G4 CGM at home during normal daily activities (including exercise and driving). Mean CGM glucose improved from 162 mg/dl on usual care to 141 mg/dl on the Bionic Pancreas, projecting an A1c improvement of 0.8% (baseline: 7.3%). Simultaneously, time <60 dropped by two-thirds (from 1.9% to 0.6%), while time >180 declined from 34% to just 20%. This is very impressive composite efficacy, particularly given the strong control group. The conclusion emphasizes the device’s ability to start up with just body weight at initialization (a huge training advantage), plus no need for carb counting and optional meal announcements. We’re glad to see this study made it into the Lancet, showing continued big-time journal publications for the closed-loop field (this year also included the MiniMed 670G pivotal in a JAMA research letter and a Cambridge closed-loop in pregnancy/labor study in NEJM). Upcoming Bionic Pancreas studies will focus on moving to a fully integrated device, the iLet: home-use bridging studies for both the insulin-only and bihormonal systems are expected in mid-2017; a pivotal of the insulin-only iLet is expected to start in 2H17; and a pivotal of the bihormonal iLet is expected to start in 2H18.
-- by Brian Levine, Adam Brown, and Kelly Close