There were major advancements in automated insulin delivery this year, and also a large debate over the name for such a system. We will look back at 2016 as the year that the artificial pancreas went from the theoretical to the practical, as the FDA approved at least one artificial pancreas system, at least in air quotes.
Below, we sum up the biggest artificial pancreas-themed stories of the year:
1. On September 28th, 2016, the FDA announced it had approved the Medtronic 670G hybrid automated system, a single-chamber integrated pump and CGM system that automatically adjusts basal insulin delivery based on glucose readings. Medtronic announces that commercial sale of the device will begin in spring of 2017.
Read more: Why I Call the 670G an Artificial Pancreas.
2. Almost immediately, debate kicks off in the diabetes community about the 670G. Some of that debate centers on the shortcomings of the system, including that it doesn’t automate bolus insulin injections. Much of the debate, however, focuses on the name, as many feel that the system doesn’t meet the requirements of an artificial pancreas (for its part, Medtronic never labeled the 670G an artificial pancreas). Jeffrey Brewer, founder of Bigfoot Biomedical, another major player in automated insulin delivery, makes a definitive statement that backs away from the term “artificial pancreas” for its device. The two pump makers’ careful avoidance of this term puts its survival in doubt.
3. Speaking of Bigfoot Biomedical, the upstart company continued to prove its seriousness in the automated insulin delivery marketplace (sigh..the term doesn’t have the same ring to it). With an eye toward FDA approval by the end of 2017, the company begins enrolling up to 50 participants in trials (you can read the experience of one trial participant here).
4. Ed Damiano’s dual-hormone bionic pancreas also experienced a name change. Damiano and others formed a company called Beta Bionics, and they dubbed the pump system the iLet. Beta Bionics raised much more than it had initially called for in its first crowdsourced fundraising efforts, and announced plans to undertake the pivotal clinical trials needed for FDA approval in 2017. An initial 11-day trial in a real world setting proved the insulin-and-glucagon system’s safety and effectiveness. (If the iLet gets approved, will it be an artificial pancreas? A debate for another time.)
5. The FDA held a webinar earlier in the year to describe efforts to speed up the process of regulatory approval for automated insulin delivery systems. Regulators are trying to closely collaborate with pump makers to see if there are development steps that can be skipped, and they are attempting to rely on as many existing quality control standards as possible, rather than create new ones. In more good news with the FDA, at the end of the year, Congress forgot to be partisan and overwhelmingly approved the 21st Century Cures Act, which promises to speed up the FDA approval process for, among other things, new medical technology (we will be reporting on this bill soon).
So we began 2016 talking about the promise of the artificial pancreas, and ended the year talking about the to-market reality of automated insulin delivery systems (we’re going to need a shorter name at some point). Whatever you want to call these devices, they represent a big step forward in less-hassle blood sugar management, and we look forward to more progress in 2017.
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