By Robert Preidt
The FreeStyle Libre Flash Glucose Monitoring System features a small sensor wire that's placed below the skin's surface and continuously monitors blood sugar (glucose) levels. People with diabetes can wave a mobile reader above the sensor wire to check their glucose levels.
The system is approved for use in people with diabetes aged 18 and older. After a 12-hour start-up period, it can be worn for up to 10 days, the FDA said.
"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," Donald St. Pierre said in an FDA news release. He is deputy director of new product evaluation in the FDA's Center for Devices and Radiological Health.
Approval of the system, made by Abbott Diabetes Care, was based on a clinical trial of diabetes patients aged 18 and older.
The system does not provide real-time alerts on its own, the FDA noted. For example, it cannot warn patients about low blood glucose levels while they're sleeping.
Potential risks associated with the system include low or high blood sugar if data it provides is inaccurate and used to make treatment decisions, the FDA said. Some patients may also have mild skin irritation around the area where the sensor wire is inserted.
More than 29 million people in the United States have diabetes, according to the U.S. Centers for Disease Control and Prevention.
People with diabetes either don't make enough insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes). When the body doesn't have enough insulin or can't use it effectively, sugar builds up in the blood. High blood sugar levels can lead to heart disease; stroke; blindness; kidney failure; and amputation of toes, feet or leg, according to background information in the FDA news release.