FreeStyle Libre 3 Cleared in Europe – Smaller, Thinner, and No More Scanning!
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. It is currently available in Germany and the Netherlands and it was announced in 2022 that it would be available on the UK.
Freestyle Libre 3 Features
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.
Where is the Freestyle Libre 3 worn?
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.
How much does the Freestyle Libre 3 cost?
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.
Where is the Freestyle Libre 3 available?
The FreeStyle Libre 3 launched initially in Germany, with limited availability in the Netherlands. In March 2022, Abbott announced that the FreeStyle Libre 3 would be made available in the UK via the NHS Supply Chain Framework. It appears that the NHS will cover this CGM for everyone with type 1 diabetes and people with type 2 diabetes who are at risk for severe hypoglycemia or who have "unstable blood sugar."
When will the Freestyle Libre 3 become available in the US?
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!