For Immediate Release: September 27, 2017The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”).The system 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.“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.”People with diabetes must regularly test and monitor their blood sugar to make sure it is at an appropriate level, which is often done multiple times per day by taking a fingerstick sample and testing it with a blood glucose meter. Typically patients use results of a traditional fingerstick test to make diabetes treatment decisions; however, fingerstick testing is not needed to inform appropriate care choices or to calibrate glucose levels with this system.According to the Centers for Disease Control and Prevention, more than 29 million people in the U.S.

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Glucose is a very serious matter for diabetics. As a result, there is enormous interest in tools that can be used to make monitoring glucose easier, as shown by the continuing rise of continuous glucose monitors such as FreeStyle Libre. The Abbott FreeStyle Libre has come as an entirely new concept in glucose monitoring by providing much greater data than blood glucose testing whilst being more affordable than continuous glucose monitors (CGM). The FreeStyle Libre provides ‘flash glucose monitoring’ with glucose readings provided by scanning a sensor rather than pricking your finger.

Have diabetes. People with diabetes either do not make enough insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes). When the body doesn’t have enough insulin or cannot use it effectively, sugar builds up in the blood.