FDA clears freeStyle Libre 3 system for use by people aged 4 years and older living with diabetes

ABBOTT PARK, Ill: The US FDA has granted clearance clearance to FreeStyle Libre 3 system from Abbott for use by people aged 4 years and older living with diabetes.

The FreeStyle Libre 3 is expected to be available later this year at participating pharmacies and will be available at the same price as previous versions of the system according to a statement by Abbott.

"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."

FreeStyle Libre 3 System Features:

Greatest accuracy-with a 7.9% overall mean absolute relative difference (MARD), the FreeStyle Libre 3 system is the most accurate 14-day continuous glucose monitor (CGM) with readings sent directly to a smartphone every minute.6 It's the first CGM to demonstrate a sub-8% MARD1,6-which is the standard way to measure continuous glucose accuracy-the lower percentage, the better.

Smallest and thinnest-at the size of two stacked U.S. pennies (worn inconspicuously on the back of one's upper arm), it's the smallest and thinnest4,7 CGM sensor in the world.

Even easier to use-with a one-piece applicator the sensor is uncomplicated to apply.4

Strongest Bluetooth® integration with a range of up to 33 feet-50% further range than other CGMs.4,8

Priced for Access and Affordability

Abbott will price the FreeStyle Libre 3 system the same as previous versions9 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.10 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.10

"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."

Digital Health Tools

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.11

The mobile app integrates with the FreeStyle Libre digital ecosystem, including LibreView and LibreLinkUp,12,13,14 enabling caregivers and healthcare professionals to remotely monitor loved ones and patients as needed.

Availability

The FreeStyle Libre 3 sensor will be available at participating pharmacies later this year.15

Recognized Health Tech Innovator

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

1. Consumer Technology Association's 2022 Consumer Electronics Show (CES) Best Health & Wellness Innovation

2. The Edison 2022 Gold Award for Science & Medical, Technology & Tools

3. Business Intelligence Group's 2022 Healthcare Innovation Award

4. Medical Device and Diagnostic Industry's 2022 Medical Design Excellence Bronze Award for Digital Health Products and Mobile Medical Apps; and

5. Lucintel's 2021 Product Innovation Award in the Biosensors Market

The FreeStyle Libre portfolio is the most widely used continuous glucose monitoring system in the U.S. and worldwide and has changed the lives of approximately four million people across more than 60 countries.17 Abbott has secured partial or full reimbursement for the FreeStyle Libre system in over 40 countries, including Canada, France, Germany, Japan, the United Kingdom, and the U.S.5 For more information visit FreeStyleLibre.com.

Indications and Important Safety Information

Failure to use FreeStyle Libre 3 system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us safety info.