The Food and Drug Administration (FDA) has approved the FreeStyle Libre Flash Glucose Monitoring System, a continuous glucose monitoring (CGM) device indicated for the management of diabetes in patients 18 years of age and older. The device, which requires a prescription, is designed to replace blood glucose testing for diabetes treatment decisions and is intended for single patient use.

“The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health. “This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes—with a wave of the mobile reader.”

The FreeStyle Libre system reads glucose levels through a sensor that is worn on the back of the upper arm for up to 10 days. By waving a hand-held reader above the sensor, patients are able to capture real-time glucose readings; this can done through clothing. The sensor is also water-resistant and doesn’t require removal for bathing or swimming.

Studies have shown (Ong, WM et al. 2014) that many individuals using traditional blood glucose monitors don’t test as often as they should during the day. A trial (Dunn T et al. 2017) of ≥50,000 diabetes patients, that lasted 18 months, found that FreeStyle Libre users checked their glucose on average 16 times a day, 3 times more than the minimum recommended testing with traditional fingerstick testing. 

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“What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise and specific medications on their glucose levels due to availability of the data,” said Maria Tulpan MD, Lenox Hill Hospital, NY.

The FreeStyle Libre system will be available via prescription before the end of the year in the U.S. 

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