Artificial Pancreas Approved by FDA Marks a Global FirstBy and
Medtronic device measures blood sugar and supplies insulin
DexCom, maker of glucose monitors, falls after approval
Medtronic Plc will bring to market the world’s first artificial pancreas, after U.S. 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 Wednesday.
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 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 U.S. next summer.
The agency’s decision sent shares of rival DexCom Inc. down 4.1 percent to $89.84 at the close in New York, the biggest one-day decline since February. DexCom makes continuous glucose monitoring systems used by diabetics, which could be displaced by Medtronic’s device.
Medtronic said it wouldn’t be ready to introduce the MiniMed 670G until the spring of 2017. Its shares were little changed at $86.73.
Type 1 Diabetes
About 1.25 million people in the U.S. 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.
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.
It works without limited human involvement with the exception of mealtime, when patients need to manually control the dose of insulin before eating. Patients also need to periodically calibrate the system. The FDA is requiring Dublin-based Medtronic to conduct additional studies on how the system will perform in routine daily life. It carries risks including blood sugar levels that fall too low or rise too high, as well as skin irritation around the infusion patch.
The 670G was approved based on a study involving 123 patients who safely used the device for three months. It’s specifically designated as unsafe for children age 6 and younger, though Medtronic is testing the system in patients aged seven to 13.