Abbott’s FreeStyle Libre 3 approved by FDA

The Food and Drug Administration has given Abbott approval for its next-generation FreeStyle Libre 3 system for use by people aged 4 years old and older who are living with diabetes.

"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," said Jared Watkin, senior vice president of Abbott's diabetes care business. "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 continuous glucose monitoring system."

Abbott noted that the FreeStyle Libre 3 System features a 7.9% overall mean absolute relative difference. "The FreeStyle Libre 3 system is the most accurate 14-day continuous glucose monitor with readings sent directly to a smartphone every minute. It's the first CGM to demonstrate a sub-8% MARD – which is the standard way to measure continuous glucose accuracy — the lower percentage, the better." the company said.

Furthermore, Abbott said the system has the strongest Bluetooth integration with a range of up to 33-ft. — 50% further range than other CGMs."

"At the size of two stacked U.S. pennies (worn inconspicuously on the back of one's upper arm), it's the smallest and thinnest CGM sensor in the world. It's even easier to use — with a one-piece applicator the sensor is uncomplicated to apply," Abbott said.

[Read more: The future of diabetes care: Partnering with pharmacies to address the critical needs of people with diabetes]

Abbott will price the FreeStyle Libre 3 system the same as previous versions with the goal of enabling the greatest number of people living with diabetes to benefit from the next-generation technology. 

"We continue to disrupt the notion that CGMs have to sacrifice quality or accuracy for affordability," said Watkin. "Access to breakthrough diabetes technologies should not be out of reach for the people who can benefit most from them. Innovation for access and affordability is a core pillar in Abbott's business and sustainability strategy." 

There is a vast and growing need for new innovations in diabetes care. There are now more than 133 million Americans living with diabetes or prediabetes (nearly half of the U.S. population), according to the American Diabetes Association. The organization also notes that diabetes is the most common underlying chronic condition in the U.S. and 1.4 million Americans aged 18 years or older are newly diagnosed with diabetes each year, which equates to one every 23 seconds, the company said. 

"I have seen real-world evidence that diabetes technologies like CGMs have helped my patients safely achieve improved glycemic control," said Dr. Eugene E. Wright, Jr., consulting associate at Duke University's department of medicine.  "I applaud Abbott for making their CGM system the most affordable and addressing disparities in care so patients living with diabetes can avoid complications and optimize their quality of life."

[Read more: CVS Health, ADA join forces to support diabetes prevention/management]

The FreeStyle Libre 3 system was cleared for use with the FreeStyle Libre 3 iOS and Android mobile apps, which enable users to view their glucose levels in real time, track their glucose history and trends and set up optional alarms plus notifications to help them be alerted of serious medical events like hypoglycemia.

The mobile app integrates with the FreeStyle Libre digital ecosystem, including LibreView and LibreLinkUp, enabling caregivers and healthcare professionals to remotely monitor loved ones and patients as needed.

The FreeStyle Libre 3 sensor will be available at participating pharmacies later this year.

Over the last year, the FreeStyle Libre 3 system has been recognized multiple times16 as a top health tech innovation by:

• Consumer Technology Association's 2022 Consumer Electronics Show Best Health & Wellness Innovation;
• The Edison 2022 Gold Award for Science & Medical, Technology & Tools;
• Business Intelligence Group's 2022 Healthcare Innovation Award;
• Medical Device and Diagnostic Industry's 2022 Medical Design Excellence Bronze Award for Digital Health Products and Mobile Medical Apps; and
• Lucintel's 2021 Product Innovation Award in the Biosensors Market