Freestyle Libre 2: Next-Gen CGM is Here

Abbott's world-leading glucose technology primed for expansion with U.S. clearance of FreeStyle Libre 2 system.

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Strategy and Strength | June 15, 2020

Where does the revolutionary system that’s quickly risen from launch to the world’s leader1 in helping people live with diabetes go from here?

To even more people in more places.

The U.S. Food and Drug Administration cleared FreeStyle Libre 2 system as an integrated CGM (iCGM), adding a pediatric designation (now for children 4 and older with diabetes) and offering more features, including optional real-time alarms to alert you when glucose levels get too high or low.2

“Diabetes growth momentum clearly continues to ramp with Libre,” wrote SVB Leerink analyst Danielle Antalffy.

The FreeStyle Libre 2 system lets users check their glucose levels as often as they like without having to fingerstick,3 a life-changing innovation that lets people live better and gain deeper understanding of their glucose levels. 

A Market Standout

The global marketplace for glucose monitoring remains vast and growing with 463 million adults living with diabetes, according to the International Diabetes Federation (IDF). This number is projected to balloon 51% to 700 million people by 2045, IDF data show.

The market for high-tech diabetes devices, which includes CGMs and insulin pumps, is approximately $7 billion, making it the fastest growing medtech market over $1 billion, according to Raymond James Financial analyst Jayson Bedford.

FreeStyle Libre 2 is a standout in this market, here’s why:

  • Unsurpassed 14-day5 accuracy — The FreeStyle Libre 2 system has a combined mean absolute relative difference (MARD), a measurement of performance for CGMs, of 9.3% (9.2% for adults and 9.7% for pediatrics), making it the only iCGM sensor sustaining a high level of accuracy over 14 days.
  • Minute-by-minute glucose readings — FreeStyle Libre 2 system is the only iCGM system that measures glucose every minute. That’s five times more glucose readings than competitors.1,6
  • Longest lasting self-applied sensor — At 14 days, the next-gen FreeStyle Libre 2 system is the longest lasting iCGM sensor available.
  • Fewer false alarms — FreeStyle Libre 2 has one third fewer false alarms for children than Dexcom’s G6.7,8
  • Accessible and affordable — Compared to other CGMs, FreeStyle Libre 2 will be a third of the cost in the U.S.9 Overall, there are more than 2 million users of FreeStyle Libre family of products worldwide,1 and Abbott has secured partial or full reimbursement for the FreeStyle Libre portfolio in 36 countries including Canada, Japan, the United Kingdom and the U.S. 

Learn more about the U.S. approval of FreeStyle Libre 2.

1Data on file. Abbott Diabetes Care.
2When alarms are turned off, notification will not be received during low or high glucose.
3Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first 12 hours.
4Raymond James Financial, Diabetes Deep-Dive: The Continued Evolution (and Acceptance) of New Diabetes Tech, February 2020.
5FreeStyle Libre 2 User Manual.
6Dexcom G6 CGM User Guide.
7Not based on head-to-head study.
8FreeStyle Libre 2 system user manual. Dexcom G6 CGM User Guide. Based on low glucose alarms set at 70 mg/dl for pediatrics.
9Based on a comparison of list prices of the FreeStyle Libre 14 day system versus competitors' CGM systems. FreeStyle Libre 2 system will be list priced the same rate as FreeStyle Libre 14 day system. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.

Indications and Important Safety Information

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.

WARNINGS/LIMITATIONS*:

The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit * www.freestylelibre.us for detailed indications for use and safety information.

*Please refer to www.freestylelibre.us for the indications and important safety information.