{Editor's note: This article was distributed by Chris Gray on the ACB leadership list and is edited. Chris writes:
"This is a huge step forward in the treatment of diabetes, currently only for type 1 diabetics but I'm sure that will change over time. Of course, no word
about price or its accessibility to a blind user.}
Medtronic Plc will bring to market the world's first artificial pancreas, after US regulators cleared the device for diabetics to automatically monitor
blood sugar and supply insulin, replicating what a healthy version of the organ does on its own.
The Food and Drug Administration cleared the product, called MiniMed 670G, for patients with Type 1 diabetes who are at least 14 years old. It will let
some diabetics turn over part of their daily routine of fingerprick tests and insulin injections to an automatic system. Along with lessening the burden
of a condition that requires constant attention, it also offers hope that better blood sugar control at inconvenient times, such as at night, will ultimately
improve long-term health.
"This first-of-its-kind technology can provide people with Type 1 diabetes greater freedom to live their lives without having to consistently and manually
monitor baseline glucose levels and administer insulin," Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement.
The FDA approved Medtronic's product months sooner than investors expected, and without going before a panel of outside advisers that often precedes the
introduction of innovative products. In doing so, the agency also moved faster than European regulators, who are often first to clear medical devices.
How It Works
The MiniMed 670G, which is about the size of a smartphone, wirelessly connects an insulin pump and a glucose monitor. Blood sugar levels are monitored
every five minutes by a sensor that reads just under the skin, the FDA said. A computer algorithm then ensures patients have the right amount of insulin,
a hormone that's needed to turn blood sugar into energy. Medtronic expects the device to win approval outside the US next summer. Medtronic said it wouldn't
be ready to introduce the 670G until the spring of 2017.
Type 1 Diabetes
About 1.25 million people in the US have Type 1 diabetes, where the pancreas fails to produce any insulin, according to the Juvenile Diabetes Research
Foundation. The condition typically presents in childhood, and patients walk a fine line, since too much or too little insulin can be life-threatening.
Lax blood sugar control can lead to a host of additional health problems, including heart disease, stroke, kidney and nerve damage and blindness. Type
2, which is more common, is tied to obesity and typically develops gradually. The Medtronic's device takes on the responsibilities of the human pancreas,
which is tasked by the body with producing insulin in precise quantities. While Medtronic previously released a system that could shut off if glucose levels
fell too low, it didn't automatically deliver the hormone when blood sugar climbed.
