Abbott has received Food and Drug Administration (FDA) approval for the FreeStyle Libre Flash Glucose Monitoring system, making this the first continuous glucose monitoring system approved for use in the U.S. that helps adult patients make diabetes treatment decisions without calibration using a fingerprick blood sample. The system reduces the need for fingerprick testing by inserting a small sensor wire below the skin’s surface that continuously measures and monitors glucose levels. Users then determine glucose levels by waving a mobile reader above the sensor wire. After a 12-hour startup period, the device can be worn for up to 10 days.
To evaluate the FreeStyle Libre Flash, FDA examined data from a clinical study of diabetes patients aged 18 and older, and reviewed the device’s performance by comparing its readings to those obtained by an established laboratory method used for analysis of blood glucose.