FreeStyle Libre 3 System Receives CE Mark

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Published 2020-09-28
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.

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). 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.

All Comments (21)
  • @TypeOneTalks
    Great to hear all these exciting news! Can’t wait to make a video about Libre 3! Thank you!
  • I have tried their new sensor and it was fantastic. I don't feel like I'm wearing a sensor. Your engineers did a perfect job. I measured it and the weight of the sensor is only 1 gram. Thank you for your work!
  • Congratulations to the Abbott team working to make it happen. This is great!!!
  • Newly diagnosed T2 here in America; I hope this stuff comes around sometime early next year. I’ll be using the 2 for now. Thanks for all you do!
  • @user-nr7rd9rd6u
    Great news! I hope the app will be available without region restrictions for us that are buying it from abroad.
  • Wha?! We’re still only awaiting the libre 2 in Canada 🇨🇦 🤦🏻‍♀️
  • @robintravis4268
    Fantastic, really excited. Looking forward to getting one in Sweden!
  • @carte3527
    when it will be available in Croatia?
  • @granolasoos
    Would love to see: - Up and down alerts - always on smart watch widget - available to all regions when bought online
  • @Nenea2a
    Please allow me to give some suggestions - If the sensor uses a battery, please allow us to change the battery ... so that we don't have to change the sensor every time the battery runs out, so it can cost us less. - Allow to sensor to transmit information at a greater distance (1-5 meters) - Also, if the sensor contains, together with the needle that enters the body, the battery and an electronic part, not to be needed to throw that electronic part together with the battery, but only to change the needle and then attach the electronic part with the battery. So the costs will be much lower and they will allow more people to use your product... That mean to buy only needle when is time to change... which can be attached to electronic part and battery. - Or made two tipe of sensors... a smaller one that changes completely... and which, of course, costs more... and a larger one that only allows the change the needle, with lower costs... leaving it to everyone to choose the one they can allow. - Allow the reading to be personalized in 5, 10, 15, 20, 25, 30 minutes... - To have an alarm under 75 mg/dl and over 180 mg/dl. - The software used by the phone allows the transmission of reading data over the Internet to other phones that have the consent (such as a mother, who is at work, to be able to monitor her child, who could be at home and sleep). And don't be upset that you don't earn much if we change only needle and not the sensor completely, but you can put a monthly fee of 3-5 euros on the software, just to allow various options such as monthly and annual graphs of the glucose situation or if your blood sugar is rising or falling when you read... some graphic personalisations etc... Otherwise, leave the software free only for direct reading and transmission of direct blood glucose reading. Thank you. And please allow us to know when FreeStyle Libre 3 will come. :)
  • @mojacukrzyca
    Great message. We are waiting for Libre 2 and Libre 3 in Poland!
  • @ThePATITALINDA
    Yo les quiero agradecer por este medidor, es espectacular el 1,2 y me imagino que el 3 igual. Ya llegará a Chile para conocerlo. Saludos desde Chile 🌷🇨🇱🌷
  • Been waiting YEARS for libre 2 in the UK (you know where its made?) Its been so long that you have a whole new device haha. I wonder when that will be ready? waits for generic copy/paste response