The Food and Drug Administration on Wednesday approved the first so-called artificial pancreas, an out-of-body device expected to lift the burden for some diabetics on the daily grind they must go through to keep their blood sugar levels stable. It will be available next spring for patients with type 1 diabetes who are over age 14.
The device, which looks like a smartphone, is designed to automatically monitor and administer the delivery of insulin for type 1 diabetes patients, whose ability to provide insulin naturally is impaired. It wirelessly links up an insulin pump and glucose monitor, allowing patients to partly turn over the process of testing and adjusting their blood sugar levels. It’s not unlike cruise control: Patients still have to manually control their glucose levels before they eat.
In the diabetes community, optimism about the new device is tempered by fears that it will command a high price tag that could put it out of reach for patients already grappling with the soaring cost of insulin. Medtronic (MDT), which developed the “MiniMed 670G,” has yet to announce how much it plans to charge. But spokeswoman Leslie Bryant said the company expects to offer it “at currently offered Medtronic pump system pricing” and is talking with health plans to “enable patient access.”
Medtronic’s application was approved on the back of a study that tested how 123 type 1 diabetes patients fared on the device. No patients reported developing complications like excess blood acids or low glucose levels that can result from poor monitoring of the disease.
Medtronic is also testing the device on pediatric patients. One such patient, 13-year-old Jonathan Platt of the Los Angeles area, is still using his device after the completion of the trial. “For our family, it’s been life-changing,” his mother, Angie Platt, said. She said that after an initial adjustment period, blood sugar imbalances that prompt middle-of-the-night trips to Jonathan’s room have been reduced from several times a night to half a dozen times a month.
The device’s approval brought cheers from JDRF, the world’s largest charitable funder of type 1 diabetes research. Over the past decade, the group, formerly known as the Juvenile Diabetes Research Foundation, has aggressively pushed to get such a device to market by funding research and pressing the federal government.
“I’m very excited about the fact that there is a system that will help people lead fuller, safer, higher quality lives,” said Derek Rapp, JDRF’s president and CEO.
Rapp said it’s important that people are able to afford and purchase not only the basic device but also disposable products like a catheter, tubing, and tape that go along with it.
“Medtronic is already aware of our belief that that is an important item to address,” he said.