Medtronic has developed a Bluetooth-enabled continuous glucose monitoring system for patients with diabetes, that will connect to an iOS app, Medtronic Global Program Marketing Manager Samantha Katz announced from the stage at Health 2.0 in Santa Clara, California.
MobiHealthNews has learned that though the new system is not yet FDA cleared, it will start a “pivotal clinical trial” later this fall.
“We’ve heard from our customers that they don’t like having to carry a separate display device and they feel self-conscious when they use it in public, so we want to address that.” Katz said, referencing Medtronic’s current CGM offering, the Medtronic Guardian, which uses a custom display device. “Introducing Guardian mobile, Medtronic’s first CGM system enabled by Bluetooth LE that communicates directly with the user’s smartphone.”
Although a number of noncontinuous fingerstick glucometers are smartphone-connected, the race to an app-connected CGM is still in the early stages. Notably, Dexcom filed a patent in January for such a device and Maryland-based Senseonics raised $20 million this summer with an eye on smartphone-connected CGM. And CGMs have connected to smartphones in research contexts, especially around efforts to develop an “artificial pancreas” by linking CGMs up to insulin pumps.
Said Bolorforosh, vice president of global technology at Medtronic, told MobiHealthNews in an email that regulation is a hold up, as is the high standard of accuracy CGMs need to meet for their patients.
“With a product like Guardian Mobile, the stakes are higher than your average mobile app because we’re talking about personal health,” he wrote. “And we’re talking about information related to diabetes, which is a very challenging disease to manage. So, from the technical side, it’s important that we make sure that the data is safe and secure and that changes made to the phone (software updates, new app installations etc.) don’t impact the integrity of the CGM data or how it’s displayed. Communication to a device we completely control is easier, but we want to make managing diabetes more convenient for people with diabetes who don’t want additional devices to carry around.” Keep reading>>