- Federal regulators have OK’d an mHealth device that may soon greatly improve how Type 1 diabetics manage their disease.
The U.S. Food and Drug Administration this week approved Medtronic’s MiniMid 670G artificial pancreas, which includes a wearable insulin pump, embedded sensor that measures a body’s blood glucose levels, and an infusion patch with a catheter that delivers a basal dose of insulin when the sensor indicates low insulin levels. The cellphone-sized Hybrid Closed Loop insulin delivery system uses a SmartGuard HCL analytics platform to measure blood glucose and determine insulin needs.
“This approval is a significant milestone in the history of diabetes management, and a culmination of many years of dedicated work,” Hooman Hakami, executive vice president and group president of Medtronic Diabetes, said in a blog. “With this approval, we are one step closer to delivering a fully automated closed loop system.”
The news was greeted warmly at the American Diabetes Association’s Fall Forum, taking place this week in New Orleans.
The FDA is now asking Medtronic to launch a post-market study “to better understand how the device performs in real-world settings.” As the MiniMed was approved for those age 14 and over, the company is also engaged in clinical studies evaluating its effectiveness in children age 7-13.
The artificial pancreas has long been a dream for type 1 diabetics and their caregivers – a means of replacing an organ that has basically died in the body. Type 1 diabetics test their blood sugar levels several times a day, usually by pricking their fingers and using a mobile blood-glucose sensor, and self-administer shots of insulin often to maintain a safe blood-glucose balance.
The MiniMed 670G would do much of that work for them. Roughly 1.5 million Americans have Type 1 diabetes, according to the American Diabetes Association. That’s about 5 percent of the estimated 29.1 million Americans, or 9.3 percent of the population, diagnosed with either Type 1 or Type 2 diabetes, the ADA says.
"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 E. Shuren, MD, JD, Director of the FDA’s Center for Devices and Radiological Health, said in an FDA press release.
“With SmartGuard HCL, the ability to automate basal insulin dosing 24 hours a day is a much-anticipated advancement in the diabetes community for the profound impact it may have on managing diabetes – particularly for minimizing glucose variability and maximizing time in the target range,” Richard M. Bergenstal, MD, executive director of the Park Nicollet International Diabetes Center in Minneapolis and a principal investigator in the study, said in a release issued by Medtronic.
“This significant milestone represents an important step forward in the management of type 1 diabetes and will improve the quality of life for those living with this chronic disease,” added Derek Rapp, president and CEO of the Juvenile Diabetes Research Foundation. “We are very encouraged by the speed in which this groundbreaking technology was approved by the FDA.”
Ireland-based Medtronic has been one of several companies leading the way in integrating mHealth with diabetes care management, most recently partnering with IBM’s Watson Health to add machine-learning capabilities to the decision support platform.
Others in the field include Glooko, Livongo (a company founded by former Allscripts CEO Glenn Tullman), Omada Health, Telcare, WellDoc, DexCom, Entra Health Systems and Agametrix, to name just a few.
Medtronic officials say the MiniMed 670G will be commercially available in the U.S. in early 2017 and outside the country later in the year, pending approvals in Europe and elsewhere.