The U.S. Food and Drug Administration (FDA) cleared Abbott’s 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,” says 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:

  • Improved accuracy: With a 7.9% overall mean absolute relative difference (MARD), the FreeStyle Libre 3 system is a highly 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.
  • Smaller size: 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.
  • Ease of use: With a one-piece applicator, the sensor is uncomplicated to apply.4
  • Bluetooth integration:  It features a range of up to 33 feet – 50% further range than other CGMs.4,8

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,” says 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.”  

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 portfolio is a a widely used continuous glucose monitoring system.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 

References

  1. Data on File, Abbott Diabetes Care. Comparison based on publicly available information.
  2. The FreeStyle Libre 3 app is only compatible with certain mobile devices and operating systems. Please check our website for more information about device compatibility before using the app. Use of the FreeStyle Libre 3 app requires registration with LibreView.
  3. Notifications will only be received when alarms are turned on and the sensor is within 33 feet unobstructed of the reading device. You must enable the appropriate settings on your smartphone to receive alarms and alerts, see the FreeStyle Libre 3 User’s Manual for more information.
  4. Data on file, Abbott Diabetes Care.
  5. Based on a comparison of list prices of FreeStyle Libre 3 system versus competitors’ CGM systems.  The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any. Does not include Medicare, Medicaid, and uninsured patients.  At this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursement, and Medicaid eligibility may vary by state. Abbott provides this information as a courtesy, it is subject to change and interpretation. The customer is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients. Abbott does not guarantee third party coverage or payment for our products or reimburse customers for claims that are denied by third party payers.
  6. FreeStyle Libre 3 User’s Manual.
  7. Among patient-applied sensors.
  8. Based on the signal range in Dexcom G6 CGM User Guide and Medtronic Guardian Connect System User Guide.
  9. Based on a comparison of list prices of the FreeStyle Libre 3 system versus previous generations of FreeStyle Libre Personal CGM systems.
  10. American Diabetes Association, Fast Facts: Data and Statistics about Diabetes, from the National Diabetes Statistics Report, 2022.
  11. Notifications will only be received when alarms are turned on and the sensor is within 33 feet unobstructed of the reading device. You must enable the appropriate settings on your smartphone to receive alarms and alerts, see the FreeStyle Libre 3 User’s Manual for more information.
  12. The user’s device must have internet connectivity for glucose data to automatically upload to LibreView and to transfer to connected LibreLinkUp app users.
  13. LibreView is ISO27001/27018/27701 certified and HITRUST CSF Certified.
  14. The LibreView data management software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management. The LibreView software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
  15. At this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursement, and Medicaid eligibility may vary by state.
  16. CES Innovation Award; Edison Awards; BIG Innovation Awards; Medical Design Excellence Awards; and Lucintel Award of Excellence.
  17. Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre portfolio compared to the number of users for other leading personal use, sensor-based glucose monitoring systems.