More than a year after getting the FDA nod for its CGM FreeStyle Libre 2, Abbott landed FDA clearance for the system’s iOS companion app. 

This new designation allows FreeStyle Libre 2 users to access their glucose reading on their iPhone without needing a reader. Users can scan their FreeStyle Libre app over their glucose sensor in order to see their glucose reading, as well as a trends arrow. 

The new app is cleared for use in children over 4 and adults who are living with diabetes. Caregivers are also able to get updates and alerts through the LibreLinkUP app. 

The FreeStyle Libre system currently includes a small wearable sensor that can last for 14 days and is able to continuously transmit glucose data every minute. 

When Abbott rolled out the FreeStyle Libre 2 last year, the system was able to transmit data to a handheld device so users could see their glucose readings and trends. However, at the time of the announcement the company said the system was developed to eventually be used with a smartphone device. 

WHY IT MATTERS

Currently there are 34.2 million adults in the U.S. who have diabetes, according to the CDC. The bulk of cases are Type 2 diabetes, which is typically diagnosed in adults. Patients with the disease can manage their condition with diet, exercise and medications. 

The company is pitching this as a way to help ease the disease burden for individuals living with diabetes. 

"The demands of living with diabetes can be overwhelming, and there's a critical need to improve the way people with diabetes manage their condition – easily, affordably, accurately – and in a way that seamlessly fits into their everyday lives," Jared Watkin, senior vice president for diabetes care at Abbott, said in a statement.

"The FreeStyle Libre 2 iOS app streamlines how people manage their diabetes on their iPhones – empowering users with the information they need 24/7 while improving their health on the go." 

THE LARGER TREND 

Abbott’s work in CGM tech goes back to 2017, when FreeStyle Libre became the first CGM to be FDA cleared for use without fingersticks. In June of 2020, the company landed clearance for its FreeStyle Libre 2 in the U.S. Then in December, the system got clearance in Canada for adults and children with diabetes. 

The company is already rolling out its latest version in Europe. In September of 2020, the company earned an EU CE mark for its FreeStyle Libre 3. This version is smaller than its previous sensors.

However, Abbott isn’t the only CGM on the market. Dexcom and Medtronic are among the other big names in the industry in the U.S.