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FDA OKs FreeStyle Libre 2 with Real-Time Glucose Alerts

A long-awaited upgrade of the FreeStyle Libre Flash Glucose Monitoring system from Abbott Diabetes has finally gotten the green light from regulators. The next-generation FreeStyle Libre 2 version features built-in Bluetooth to allow for optional real-time alerts for both low and high glucose levels, without the need to manually scan the sensor to trigger those alarms.

Previous versions of Libre did not include alarms, but only gave precise readings and trend arrows when users scanned the sensor worn on the arm. Now with Libre 2, users can be alerted automatically by the system if they are “out of range” (too high or too low). But to get a precise numerical reading, they still need to pick up the receiver and perform a scan.

The alarms add an important safety feature that helps put the Libre 2 more on par with other continuous glucose monitoring (CGM) products that alert users immediately if they are out of glucose range.

This much-anticipated announcement of Food and Drug Administration (FDA) approval came on Monday, June 15, during the American Diabetes Association’s 80th Scientific Sessions, held for the first time ever as a fully virtual conference due to the COVID-19 pandemic.

Our Diabetes Community has been eager for this news, since the Libre 2 first became available internationally in Fall 2018. It follows the original 10-day Libre sensor’s U.S. debut in 2017, the longer 14-day wear in mid-2018, and then the smartphone app scanning capability launched later that same year.

Abbott first filed the Libre 2 for approval in early 2019 and it’s taken more than a year to get through the regulatory review process. Here is a look at the new Libre 2, which FDA documents show was officially approved on June 12, 2020:

Scannable sensor: The sensor is a little white disc about the size and thickness of two stacked quarters that sticks onto your arm. Users just wave the handheld reader over the sensor to scan it and get readings. It’s currently approved for wear only on the upper arm, attached to the skin using an easy-push inserter device. That form factor and basic operation doesn’t change with Libre 2. With a one-second scan using a handheld reader, users can see their glucose reading, trend arrow, and eight-hour history. Like the previous version, Libre 2 has a one-hour “warmup” where it’s getting used to the person’s body before it starts generating glucose data.

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Share on PinterestThe Libre 2 sensor is stuck onto the upper arm for easy 14-day wear and scanning

Handheld receiver: Yes, a separate handheld receiver device is required. The Libre 2 receiver is blue rather than the traditional black (perhaps a nod to the built-in Bluetooth Low Energy?). Unlike the existing 14-day wear Libre that allows the use of a smartphone app for scanning, this new Libre 2 does not yet have that option. Abbott says it’s working to bring a mobile scanning app to the U.S. market ASAP.

New optional real-term alerts: If Libre 2 users have the real-time…

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