FreeStyle Libre 2 Authorized for Use in the U.S.

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On June 15, 2020, Abbott announced that the FDA has authorized the FreeStyle Libre 2 System. The Libre 2 gained its CE Mark clearance in Europe late 2018 and is now authorized for adults and children 4 and up in the United States. The FreeStyle Libre 2 is a 14 day continuous glucose monitor (CGM) system that transmits data every minute and now includes customizable high and low alerts without the need to scan the device. The Abbott announcement says it will be “a third of the cost of other CGMs.”

Also notable with this clearance is the FDA’s decision to permit the marketing of the FreeStyle Libre 2 as an integrated CGM (iCGM). This allows the CGM to be part of an interoperable system and work with other medical devices like insulin pumps, blood glucose monitors and other devices. This makes the FreeStyle Libre 2 only the second CGM on the market to receive this designation.

This also marks the first time a FreeStyle Libre CGM has been approved for pediatrics in the United States, widening the scope of potential users.

According to Abbott, the Libre 2 adds easy-to-use, customizable alarms for high and low glucose levels using Bluetooth. Users can also receive notifications should the sensor and reader fail to link up to ensure that a dropped connection does not go unnoticed. Alerts come in the form of sounds or vibrations, according to preference. Libre 2 users can still scan their sensor as often as desired to see current blood glucose levels, trends and patterns and a graph of the last eight hours.

“Another iCGM provides people with diabetes more choice to improve diabetes outcomes,” says Campbell Hutton, Vice President, Regulatory and Health Policy, Advocacy at JDRF, “and also will facilitate diabetes device interoperability.”

Content from this article was sourced from Beyond Type 1, and is reprinted here as part of the JDRF–Beyond Type 1 Alliance.

By Alexandra Mulvey