FreeStyle Libre 3 Cleared in Europe – Smaller, Thinner, and No More Scanning!
By Matthew Garza and Katie Mahoney
The FreeStyle Libre 3 has been cleared in Europe for anyone ages four and older. The new continuous glucose monitor is as small as two stacked US pennies, provides real-time readings directly to the mobile app via Bluetooth, and has the same low list price
Abbott announced that the new FreeStyle Libre 3 has been cleared in Europe – see 40-second video here. This third-generation continuous glucose monitor (CGM) has many of the same features that make the FreeStyle Libre 2 so popular, including optional alarms, 14-day wear, and high accuracy. The FreeStyle Libre 3 also adds several new features:
Real-time, minute-by-minute readings are sent directly to the FreeStyle Libre 3 app via Bluetooth – moving this CGM from “on-demand” to “always-on,” so there is no need to scan the sensor every eight hours.
It is 70% smaller than previous models, making it the “smallest and thinnest” CGM sensor yet – it’s said to be about the size of two stacked pennies. Importantly, this new model will reduce the amount of plastic and carbon paper used, improving the production of the device significantly from an environmental perspective.
It is cleared for people with diabetes as young as four years old.
It is cleared for use in gestational diabetes and pregnant women with type 1 diabetes. We suggest that everyone who is pregnant and has type 1 diabetes try to get CGM, and that everyone else who is pregnant be tested for gestational diabetes as early on as possible.
It is cleared as an iCGM, meaning it can be used for automated insulin delivery (AID) development in Europe.
The new FreeStyle Libre 3 app, available for both iOS and Android devices, will contain many of the same features as the FreeStyle Libre 2 app (Libre View) including the all-important time in range graphs and ambulatory glucose profile (AGP). You can learn all about the AGP here.
Currently the FreeStyle Libre 3 is cleared for upper-arm wear, though we imagine people may try to use it “off-label” on their abdomen or other spots. There is no separate reader for collecting and monitoring sensor data, so people will use smartphones with the FreeStyle Libre 3 app in order to connect to the sensor.
The FreeStyle Libre 3 will be available at the same price as previous versions of the CGM ($109 for a one-month’s supply, without insurance); Abbott will continue to offer the FreeStyle Libre 2 at the same price for people who prefer the to scan their CGM. The FreeStyle Libre 3 is expected to launch in the coming months in Europe, and though we don’t yet know where it will first launch, we expect it may be Germany, like Abbott’s other CGM launches. In the US, Abbott has not announced any potential timeline for FDA submission or clearance. With the recent Libre Sense clearance in Europe, there is lots happening with this brand – stay tuned for more. Readers in European countries, we’d love to hear your early thoughts once you try the FreeStyle Libre 3!