FDA Approves Abbott FreeStyle Libre Flash, a CGM That Requires No Blood Sample Calibration

September 29th, 2017 Medgadget Editors Medicine, Pediatrics

Abbott won the first FDA approval for a continuous glucose monitor that does not need to be calibrated. What this really means is that many diabetes patients can now say goodbye to having to prick their fingers on a regular basis, being able to replace blood draws completely with the new FreeStyle Libre Flash Glucose Monitoring System. Previously, existing continuous glucose monitors required at least two daily finger blood draws in order to calibrate them.

Indicated for adults only at this time, the FreeStyle Libre Flash is stuck to the back of the upper arm and then worn uninterrupted for up to ten days, even during showering and swimming. Readings obtained through the system are considered as accurate as using a traditional finger prick glucometer, and physicians can use them to make decisions on how to treat their patients.

The disposable, round sensor the system relies on is about the size of a U.S. quarter coin in diameter and that communicates wirelessly with a hand-held reader. The reader device is simply placed over the sensor and in about one second the blood glucose level is registered. Clothing that’s not too thick will not impede the transfer of data, so you won’t have to take your top off just to find out how much sugar is in your blood. In two clinical trials and in a review of users in the real-world showed that people using the FreeStyle Libre averaged 15 glucose checks, a pretty impressive amount of data that is often difficult to get patients relying on finger pricks to obtain. Moreover, they were able to avoid hypoglycemia and hyperglycemia at impressive rates while maintaining healthy glucose levels.

One interesting feature of the FreeStyle Libre Flash is that its glucose readings are not skewed much by acetaminophen, which tends to increase the measured glucose in some continuous glucose monitors.

Abbott plans to make the system available to U.S. customers by the end of the year.