MASSDEVICE ON CALL — Medtronic (NYSE:MDT) is gearing up for a pivotal clinical trial of a smartphone-enabled continuous glucose monitor it’s developed, according to MobiHealthNews.

The smartphone CGM is designed to connect Medtronic’s Guardian glucose monitor with an iOS app for iPhones, Medtronic global program marketing manager Samantha Katz revealed at Health 2.0 in Santa Clara, Calif. the website reported.

"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. "Introducing Guardian mobile, Medtronic’s first CGM system enabled by Bluetooth LE that communicates directly with the user’s smartphone."

Global technology vice president Said Bolorforosh told the site via email that the FDA sets a high accuracy bar for CGM devices.

"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." 

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