The US Food and Drug Administration (FDA) has granted clearance to Abbott’s next-generation FreeStyle Libre 3 system for use by diabetic patients aged four years and above.
The new device, which includes a continuous glucose monitoring (CGM) sensor, recorded a 7.9% overall mean absolute relative difference (MARD) and is claimed to be the most accurate 14-day CGM system.
FreeStyle Libre 3 sends glucose readings directly from the glucose sensor, which is said to be the smallest and thinnest in the world, to a smartphone every minute.
The CGM system also has strong Bluetooth integration, with a range of up to 33ft, which represents a 50% increase on other CGMs.
Abbott stated that the new device will be priced the same as previous versions of the system, in an effort to allow more diabetes patients to benefit from the new technology.
The FreeStyle Libre 3 system enables real-time glucose level viewing, glucose history tracking and optional alarms, as well as notifications for serious medical events, such as hypoglycemia.
It has been approved to pair with the FreeStyle Libre 3 iOS and Android mobile apps.
Abbott diabetes care business senior vice-president Jared Watkin said: “The FreeStyle Libre 3 system is a direct result of listening to our customers – and giving them the innovation and sensing technology they’ve been looking for.
“It’s a game-changer for the millions of people living with diabetes. They’ll be able to manage their health minute-by-minute with the world’s smallest and thinnest sensor and most accurate 14-day CGM system.”
The company stated that the mobile app integrates with the FreeStyle Libre digital ecosystem, including LibreView and LibreLinkUp, to allow caregivers and healthcare professionals to monitor users remotely.
Abbott intends to make the FreeStyle Libre 3 sensor available at participating pharmacies later in the year.