Abbott’s Freestyle Libre 3 Receives FDA Approval

On May 31, 2022, Abbott received FDA approval for its next-generation continuous glucose monitor (CGM), the Freestyle Libre 3. The device has been available in Europe since September 2020 but was delayed in the U.S. due to the COVID-19 pandemic. 

Affordability

The Freestyle Libre 3 has many of the same benefits as its predecessor, the Libre 2, with added features and improvements. However, Abbott maintains that it will not sacrifice its pricing model for the enhancements. The FreeStyle Libre 2 system is currently priced 70 percent below the list price of other CGM systems. Users can expect similar costs at the pharmacy counter or with their direct medical suppliers if the Freestyle Libre 3 matches this pricing model.

Abbott notes that most commercially insured users pay between $0 to $60 per month for FreeStyle Libre 2 sensors and no more than $65 for a FreeStyle Libre 2 reader. Without insurance, the Libre 2 may cost you anywhere from $120.46 to $148, according to GoodRX.org. Costs also depend on the availability of coupons or other discount programs. 

However, it is unclear whether the Libre 3 will be eligible for the MyFreestyle Program, which currently allows people with diabetes to try the FreeStyle Libre 2 for free for the first 14 days.

“​​We continue to disrupt the notion that CGMs have to sacrifice quality or accuracy for affordability. Access to breakthrough diabetes technologies should not be out of reach for the people who can benefit most from them,” said Jared Watkin, senior vice president of Abbott’s diabetes care business.

Benefits

Like the Libre 2, the Libre 3 offers 14 days of continuous wear for people with diabetes aged four and up. Unlike Abbott’s Freestyle Libre 2, it doesn’t need to be scanned every eight hours. The device was cleared for use with the Freestyle Libre 3 app for iOS and Android users. This next-generation model is compatible with Libre LinkUp and LibreView. 

Real-time alerts are also available for users to turn on or off as they like. You can opt to be alerted if your blood sugar is high, low, falling, or rising. Like its predecessor, the Freestyle Libre 3 is calibrated at the factory level.

The Libre 3 is easy to apply with a one-piece applicator. It is being called the world’s smallest, thinnest glucose sensor. For reference, it’s about the size of two stacked U.S. pennies. Abbott notes a 41 percent reduction in plastic use and a 43 percent decrease in carton paper. This size reduction also reduces the Libre 3’s environmental impact.

It also offers the strongest Bluetooth integration among other CGMs available today, with a range of up to 33 feet—50 percent further range than others.

Results

When measured for accuracy in clinical studies, the Libre 3 had a mean absolute relative difference (MARD) of 9.2 percent in adults and 7.9 percent overall. MARD measures the absolute error between all CGM values and matched reference values (like comparing your CGM reading to your blood glucose meter reading). 

In general, lower MARD scores indicate higher device accuracy.

With cases of diabetes rising across the world and the International Diabetes Federation’s prediction that 700 million people will have a form of diabetes by 2045, Abbott remains dedicated to “continuous innovation.” 

The Freestyle Libre 3 reflects that mission.

Editor’s note: As of Oct. 6, 2022, Freestyle Libre 3 is available at retail pharmacies across the U.S.