FreeStyle Libre 3 System Receives CE Mark

FreeStyle Libre 3 System Receives CE Mark

Monday, September 28, 2020 - 8:30am

CONTENT: Multimedia with summary

The much-anticipated FreeStyle Libre 3 system — featuring the world’s smallest, thinnest¹ glucose sensor (about the size of two stacked U.S. pennies) — has received CE mark for people with diabetes in Europe. This next-gen system provides the same benefits of FreeStyle Libre 2, including unsurpassed 14-day² accuracy and optional glucose alarms, but also evolves the portfolio with new features, such as continuous real-time glucose readings automatically delivered to a person’s smartphone every minute, and a sensor that’s easy to apply with a one-piece applicator.

The FreeStyle Libre 3 system is designed to fit seamlessly into people’s lives, enabling users to discreetly check their glucose as often as they like without having to fingerstick.³ This is a life-changing innovation that lets people live better and gain deeper understanding of their glucose levels. Abbott’s FreeStyle Libre 3 is unparalleled in the market, here’s why: 

  • Unsurpassed 14-day accuracy² — The FreeStyle Libre 3 system has a mean absolute relative difference (MARD), a measurement of performance for CGMs, of 9.2% for adults and 9.7% for pediatrics. This latest tech and FreeStyle Libre 2 are the only CGM sensors sustaining a high level of accuracy over 14 days.
  • More environmentally sustainable — Reducing the system’s total volume by more than 70%,5 Abbott designed FreeStyle Libre 3 to be more sustainable for the environment, including a 41% reduction in plastic use and 43% decrease in carton paper.⁴
  • Affordable⁵ — To allow as many people as possible living with diabetes to access and benefit from the tech, Abbott’s FreeStyle Libre 3 system will be priced the same as previous generations of the device, which is a third of the cost of other CGMs available.⁵
  • Market Leader In just four months, Abbott has achieved three key milestones for its sensor-based glucose monitoring tech: FreeStyle Libre 2 was cleared in June by the U.S. Food and Drug Administration for adults and kids ages 4 and up with diabetes; Libre Sense Glucose Sport Biosensor was CE marked in September for athletes ages 16 and up who don’t have diabetes; and now, FreeStyle Libre 3 has received CE mark for ages 4 and up with diabetes. "Abbott won’t stop innovating when there’s room to raise the bar. We’ve done that again with FreeStyle Libre 3, the smallest sensor that delivers life-changing benefits and best-in-class accuracy," said Jared Watkin, senior vice president, Diabetes Care, Abbott. Abbott is launching the FreeStyle Libre 3 system in Europe in the coming months.

Market Leader

In just four months, Abbott has achieved three key milestones for its sensor-based glucose monitoring tech: FreeStyle Libre 2 was cleared in June by the U.S. Food and Drug Administration for adults and kids ages 4 and up with diabetes; Libre Sense Glucose Sport Biosensor was CE marked in September for athletes ages 16 and up who don’t have diabetes; and now, FreeStyle Libre 3 has received CE mark for ages 4 and up with diabetes. "Abbott won’t stop innovating when there’s room to raise the bar. We’ve done that again with FreeStyle Libre 3, the smallest sensor that delivers life-changing benefits and best-in-class accuracy," said Jared Watkin, senior vice president, Diabetes Care, Abbott. Abbott is launching the FreeStyle Libre 3 system in Europe in the coming months.

References

¹ Among patient-applied sensors. Data on file, Abbott Diabetes Care

² Alva, Shridhara, Timothy Bailey, Ronald Brazg, Erwin S. Budiman, Kristin Castorino, Mark P. Christiansen, Gregory Forlenza, Mark Kipnes, David R. Liljenquist, and Hanqing Liu. “Accuracy of a 14-Day Factory-Calibrated Continuous Glucose Monitoring System With Advanced Algorithm in Pediatric and Adult Population With Diabetes.” Journal of Diabetes Science and Technology, (September 2020). https://doi.org/10.1177/1932296820958754.

³ Finger pricks are required if glucose readings do not match symptoms or expectations.

⁴ Compared to other FreeStyle Libre systems; Data on file, Abbott Diabetes Care.

⁵ Based on a comparison of list prices of the FreeStyle Libre portfolio versus competitor CGM systems available worldwide. The actual cost to patients may or may not be lower than other CGM systems, depending on local reimbursement, if any.