The FDA has approved the first continuous glucose monitoring system that will allow adults to make diabetes treatment decisions without taking a blood sample from the fingertip, often called a “fingerstick.”
The FreeStyle Libre Flash Glucose Monitoring System (Abbott Diabetes Care Inc.) reduces the need for fingerstick testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire to determine if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), and how glucose levels are changing. It is intended for use in people 18 years of age and older with diabetes; after a 12-hour start-up period, it can be worn for up to 10 days.
“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,” 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.
People with diabetes must regularly test and monitor their blood sugar to make sure it is at an appropriate level; they often do so multiple times per day.
The FDA evaluated data from a clinical study of individuals 18 years of age and older with diabetes, and reviewed the device’s performance by comparing readings obtained by the FreeStyle Libre Glucose Monitoring System to those obtained by an established laboratory method used for analysis of blood glucose.
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. It 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.
Source: FDA; September 27, 2017.