FDA clears LifeScan's long-awaited iPhone diabetes app

By Brian Dolan
03:35 am

OneTouch Verio SyncAfter almost exactly four years, Johnson & Johnson company LifeScan has announced the launch of a Bluetooth-enabled glucose meter and companion iPhone app similar to the one the company showed off on-stage at an Apple World Wide Developer's Conference in 2009 for the launch of iPhone 3.0. As MobiHealthNews exclusively reported following the Apple presentation, the LifeScan demonstration was really just a prototype at the time and no product launch was imminent. At the beginning of March the FDA cleared LifeScan's OneTouch Reveal Diabetes Application with a 510(k). The company cited WellDoc's DiabetesManager as its predicate device.

The new LifeScan app works with the OneTouch Verio Sync Meter and similar software is embedded in the OneTouch Verio IQ meter, according to the 510(k) summary document. The Verio Sync meter sends blood sugar test results directly to the app, which works with and Apple mobile devices running iOS 4+ operating systems, including iPhones, iPod touch devices, and iPads.

The app can store up to 2,500 blood glucose results and events and up to one year of results and events. The app synchronizes its time with the meter; makes it easy to tag meals and add notes; alerts the user of one or more patterns found in results once downloaded; enables user to manually enter data like results, carbs, activity, or medication; and allows user to share blood glucose results via text message or email.

LifeScan also tested the app with 168 trial users, including about two dozen children, at two different sites, according to its FDA clearance document. The studies were just to determine the app's usability, and user feedback was overwhelmingly positive. (Read more in the PDF document over at FDA's database here.)

At least one person from the original LifeScan team that helped put together that Apple presentation in 2009 is no longer with the company: Anita Mathew, the Lifescan executive demonstrating the meter at the Apple event, co-founded her own mobile diabetes startup, Glooko, in late 2011. Glooko developed a cable and companion app that connects a number of the most popular meters to Apple's devices.

Of course, the most high profile iPhone-enabled glucose meter to have launched since the LifeScan demo in 2009, was Sanofi's iBGStar, which AgaMatrix helped them develop. In December 2011 the FDA cleared the iBGStar, a tiny glucose meter that plugs directly into the the iPhone 3GS and iPhone 4+ devices' connector port, and feeds data into an app on the device.

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Dr. Garth Graham at an event in 2016. Photo by D Dipasupil/Getty Images for Harlem EatUp!

Dr. Garth Graham at an event in 2016. (Photo by D Dipasupil/Getty Images for Harlem EatUp!)



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