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."

On the app, which will work with a future generation of Medtronic's existing sensor, users will be able to set their own custom ranges and be alerted by a push notification or an alarm when their glucose goes over or under a certain level. Medtronic is also looking into ways for users to share that data with physicians or care teams via the cloud.

"Guardian Mobile is usable as a logbook, so users can enter events that could affect their diabetes," Katz said. "For example if I tap on the blue insulin vial on the top, it gives me information about insulin that I’ve taken, and I tap on the yellow fork and knife icon it gives me information about carbs that I’ve had to eat."

The benefits to smartphone-connected CGM are myriad. It could allow multiple stakeholders -- think parents of children with diabetes -- to get readouts from the same continuous monitor. It allows users more freedom to interact with their current and historical glucose data, as Katz showed in her demo at Health 2.0. And, of course, it brings the data into a location where it can be linked to other data the user might be tracking on his or her smartphone.

"We know that glucose information is just one piece of the puzzle and users want a holistic view of their health, which means incorporating glucose data with other data such as diet, fitness, sleep etc.," Katz said. "We’re really excited about the apps we’ve seen that aggregate data in one place, and Guardian Mobile is the first step in that direction, where it integrates glucose information with all the events that can affect your diabetes."

Bolorforosh clarified that an Apple HealthKit integration isn't on the table for the initial launch of the system, nor is connection to electronic health records. But he strongly hinted both were possibilities for the future.