Last week, the Food and Drug Administration approved the first ever “artificial pancreas,” a wireless, out of body device designed to free diabetics from the burden of constantly adjusting insulin levels to keep their blood sugar stable.
About the size and shape of a smartphone, the device wirelessly links to an insulin pump and glucose monitor, measuring glucose levels every five minutes and then, with the help of some algorithmic data crunching, automatically administers or withholds insulin.
It isn’t quite fully automatic—users will still have to adjust their own insulin levels before meals—but the device disproves long-held fears that outsourcing blood glucose regulation to a computer might be a fatal mistake.
Via STAT News:
“Academics had been trying for years to develop algorithms to power a fully automated system for regulating blood glucose, a task that again and again proved unfeasible. Device makers were squeamish about letting a computer control an insulin delivery system that could kill a patient if it malfunctioned at the wrong time. And even if somebody could build an artificial pancreas, no one knew what kind of tests and data the FDA would require to be convinced that it was safe and effective.”
The device, made by Medtronic, was approved after a study that tested 123 type 1 diabetes patients and found they developed no complications, like excess blood acids or low glucose levels. It will be available starting next spring for patients with type 1 diabetes over the age of 14.
There are still concerns that the device will be costly and out of reach to the patients who need it most. But overwhelmingly, the news was received with optimism. As STAT News put it, the artificial pancreas essentially puts managing diabetes into “cruise control.”
Some more good news: While the FDA often lags behind in adopting rules to regulate novel, life-changing technologies, the artificial pancreas was approved in just 103 days. And that, truly, is unprecedented.