Sanofi gets FDA clearance for insulin dose calculator app

By Jonah Comstock
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GoMeals Sanofi-aventis U.S.Following in the footsteps of Eli Lilly and Roche, Sanofi has quietly received FDA clearance for a smartphone app with a built-in insulin dose calculator. According to FDA documents, the app, cleared at the end of March, is called My Dose Coach. A pending trademark application gives a more in-depth description of the app, describing it as "downloadable software in the nature of a mobile application for use by patients with diabetes, for calculating and monitoring insulin dosages". The trademark application also suggests the app will contain some kind of database of diabetes information. We've reached out to Sanofi for comment and will update this story if they reply. 

While there are a number of insulin dosage calculator apps available, not many are FDA-cleared despite clear guidance from the FDA that insulin dosage apps require premarket approval. A 2015 study found 46 such apps on iOS and Android stores and reported that "none of the apps included in this study appear to have completed registration, labeling, or other general controls which are the minimal requirements for products in both regimes".

A few pharma companies have bucked the trend recently though. Eli Lilly recieved FDA 510K clearance in January for a new mobile app called Go Dose, a diabetes management and insulin dosing app for users of Humalog, Lilly's rapid-acting insulin. The clearance is for prescription use, but includes two versions of the app: Go Dose, for patients, and Go Dose Pro, for healthcare providers.

Diabetes management app mySugr offers a bolus calculator to European customers but hasn't introduced it to the US because of the regulatory burden. And Eli Lilly's choice of predicate devices in its January clearance -- desktop and Palm Pilot software -- further suggest very few if any FDA clearances exist for smartphone-based insulin dosage calculators. There is at least one, however: Roche's Accu-Check connect app, which launched in 2015, well ahead of the trend.

Sanofi, for its part is no stranger to app launches, and has in fact had one of the most popular apps for people with diabetes in the app store for years. Food tracking app GoMeals, by Sanofi-Aventis, is designed to help people living with diabetes make healthy food choices, but can be used by anyone who is interested in tracking the nutritional content of their meals. The app includes access to CalorieKing’s nutritional database, which contains more than 25,000 common food items and more than 200 restaurant menus.

Sanofi makes the insulin Lantus, which can be delivered via vial and needle or via an injection pen called SoloStar.