Roche launches FDA-cleared diabetes app with insulin calculator in US

By Jonah Comstock
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ROche Bolus AdvisorLast month, Roche quietly launched its Accu-Chek Connect app, a diabetes management app which contains, among other things, an unprecented feature: a prescription insulin bolus calculator called Bolus Advisor. Roche has been selling the app in other countries for a little while, even issuing a brief recall in April in some of those countries. It received FDA clearance for the Android version of the app in mid-March and finally received clearance for the iOS version in early June, using the Android clearance as the predicate device.

The app gives people with diabetes a choice of reports to help identify trends and patterns in blood sugar levels and lets them share their data with their caregiver or healthcare team via connected online accounts, email or text message. It receives data from the Accu-Chek Aviva Connect Bluetooth-enabled meter. As of June 27, the app is now available in the United States for both iOS and Android devices. 

“The development of the Accu-Chek Connect system underscores Roche Diabetes Care’s commitment to advancing technology that empowers people with diabetes to focus on the daily wins of managing diabetes and living life as normally and actively as possible,” a Roche spokesperson told MobiHealthNews in an email when the app received clearance. “Long-term diabetes management success isn’t achieved with one sweeping action, but is realized through a series of small victories that help improve overall patient adherence, clinical outcomes and quality of living.”

The Bolus Advisor feature provides "Bolus insulin advice based on blood glucose and carbohydrates for those using bolus/basal insulin therapy," the company says in the app store description. Furthermore, Roche says the feature "must be activated by your healthcare professional with appropriate information needed for setup and use." Although most of the app was cleared for over-the-counter use, the Bolus Advisor was cleared for prescription use only in Roche's recent FDA clearance.

In addition to the Bolus Advisor, the app allows users to log meals (size, carbs, or calories), insulin, exercise, medications, blood pressure, weight and health state. They can also add notes and photos to the record, which users can optionally share with their healthcare team through connected accounts, email, or SMS.