The Food and Drug Administration has given its clearance to the first continuous glucose monitoring system that can be used to make diabetes treatment decisions in adult patients without calibration using a blood sample from a traditional fingerstick test.
The FreeStyle Libre Flash Glucose Monitoring System, made by Abbott Diabetes Care, uses a small sensor wire inserted below the skin’s surface to measure blood sugar levels. A mobile reader above the sensor wire enables users to determine if these levels are too high or too low.
“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,” added St. Pierre.
The reader stores 90 days of glucose data, displaying the user’s current reading, the latest eight hours of continuous glucose data, as well as a trend arrow showing if glucose levels are going up, down or changing slowly.
According to the FDA, in making its decision the regulatory agency evaluated data from a clinical study of diabetic patients age 18 and older and reviewed the device’s performance by comparing readings from the FreeStyle Libre Glucose Monitoring System with those obtained by an established laboratory method used for analysis of blood sugar. The device can be worn for as long as 10 days, following a 12-hour start-up period.
Nonetheless, the agency warns that the “risks associated with use of the system may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate and used to make treatment decisions, as well as mild skin irritations around the insertion site.”
In addition, the FDA reveals that the FreeStyle Libre Glucose Monitoring System “does not provide real-time alerts or alarms in the absence of a user-initiated action; for example, it cannot alert users to low blood glucose levels while they are asleep.”
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