Sept. 28 (UPI) — The U.S. Food and Drug Administration Wednesday approved the first continuous glucose monitor that can be used by adults without calibration via a fingerstick.
The FreeStyle Libre Flash Glucose Monitoring System uses a small sensor wire inserted below the skin’s surface that continuously monitors blood glucose levels, with users waving a mobile reader above the sensor wire to determine glucose levels and trends for patients with diabetes.
“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,” 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, said in a press release.
Current CGM systems require blood glucose calibration using a fingerstick prior to using a CGM, meaning the new device could make life a little less painful for some of the 29 million people in the United States who have been diagnosed with diabetes.
The FDA analyzed data from a clinical study of adults with diabetes and compared blood glucose readings by the FreeStyle Libre Flash and readings obtained by standard laboratory methods used for analyzing blood glucose levels.
The agency has approved the device for use in adults 18 and older who have diabetes, and can be worn for up to 10 days after a 12-hour start-up period.
“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.”