FDA Gives Nod to FreeStyle Libre Glucose Monitoring System

The US Food and Drug Administration announced the approval of the first continuous glucose monitoring system that can be used by adult patients to make decisions about treatments without calibration from a fingertip blood sample.

The FreeStyle Libre Flash Glucose Monitoring System, produced by Abbott Diabetes Care Inc, reduces the requirement of “fingerstick” testing, where diabetics would be required to prick their fingers to gather a blood glucose sample. The system uses a small sensor wire that is inserted below the surface of the skin and continuously monitors and measures levels.

“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 statement. “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.”

Patients using the device can determine their glucose levels by waving a mobile reader above the sensor wire to identify times of hyperglycemia and hypoglycemia, as well as how the levels are changing. It can be worn for up to 10 days after a 12-hour start-up period. It is intended to be used only by adults aged 18 and older.

The device was approved based on data from a clinical study of adults over the age of 18 with diabetes and compared the readings obtained by the FreeStyle Libre Glucose Monitoring System to those gathered by the current laboratory method for blood glucose analysis.

The risks associated with the system include hypo- and hyperglycemia in cases where the device is inaccurate and treatment decisions are made, as well as irritation of the skin around the insertion site. The device also does not alert users of low blood glucose levels while they are asleep, according to the FDA.

According to data from the Centers for Disease Control and Prevention (CDC), more than 29 million diabetics currently live in the United States.