FreeStyle Libre 3 gets FDA clearance opening up the US market for the world's smallest and most-accurate 14-day continuous glucose monitor
Abbott’s FreeStyle Libre 3 CGM has been available for use in the UK for a few months now, but it has only just received FDA clearance that will open up the US market for the tiny monitor. The company’s official press release for the CGM claims that it is the “world’s smallest, thinnest and most accurate 14-day glucose sensor”. Abbott is hoping to keep costs for the FreeStyle Libre 3 down, stating that the new device will be priced at the same level as previous iterations. The FreeStyle Libre 2 apparently costs around US$2,300 a year before insurance is considered.
Apart from being both very small and thin (see image comparison with the pennies below), the FreeStyle Libre 3 offers the kind of accuracy that is vital for people with diabetes to avoid hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar) episodes. The mean absolute relative difference (MARD) is reportedly 7.9%, with a lower figure indicating higher accuracy. The FreeStyle Libre 3 sends information to a connected smartphone every minute, giving users the continuous glucose monitoring that is required for effective diabetes management.
Although replacing the sensor does involve relatively painless invasiveness, with some bruising or bleeding possible when attaching the FreeStyle Libre 3 to the back of the upper arm with the applicator, the CGM then offers 14 days of freedom from finger-sticking (often required for calibration). Application is a quick and simple process, with the discreet continuous glucose monitor offering a useful water-resistance level for up to 30 minutes. Availability of the Abbott FreeStyle Libre 3 CGM in the US is expected to begin later this year.
Abbott's FreeStyle Libre® 3 Receives U.S. FDA Clearance - Features World's Smallest, Thinnest and Most Accurate 14-Day Glucose Sensor
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May 31, 2022, 08:00 ET
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The FreeStyle Libre 3 system is the most accurate 14-day continuous glucose monitor1, with readings sent directly to a smartphone every minute.2
Designed for access and affordability, the FreeStyle Libre 3 system will be available at the same price as previous versions, which is one-third the cost of other competing continuous glucose monitoring systems available today.3,4
ABBOTT PARK, Ill., May 31, 2022 /PRNewswire/ -- Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) cleared its next-generation FreeStyle Libre 3 system for use by people four years and older6 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."
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.
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:
Consumer Technology Association's 2022 Consumer Electronics Show (CES) 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
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.
About Abbott Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.