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. “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. 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. 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. 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. 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”). A disposable inserter that comes with each sensor makes placing thesensor quick and painless aįda Approves First Continuous Glucose Monitoring System For Adults Not Requiring Blood Sample Calibration Literature from Abbott tells us it must be worn on the back of theupper arm. Sensor/Transmitter: By comparison to the existing CGMsensors on the market, this one is ultra-flat and about the size of aquarter. The Libre systemconsists of a combined sensor/transmitter, and a handheld receiver that Abbottcalls a reader. Letsbackup to offer a bit of background, for starters. Here aremy initial impressions of the Libre system, after using it for a couple weeks. The FDA approved this new system in September and launched it the week of Thanksgiving, and Abbott offered us at the 'Mine a test-drive along with some others in the Diabetes Online Community. And for once,this economic juggernaut would also benefit the vast majority of people withdiabetes, especially those living with type 2. Pricedright, and covered by insurance, I knew in a flash that Abbott was poised tomake a fortune and to re-write the rules of glucose monitoring. But withinminutes of booting up one of two sample sensors provided for review, I knew Abbott had a potential game-changer on their hands. Thisso-called Flash Glucose Monitoring seemedlike a waste of modern D-tech to me. You'd have to wave the monitor over the sensor to get that poof! And like magic it would tell you your blood sugar. It was billed as sort of a magicwand that used a sensor stuck onto your body like a regular CGM (continuous glucose monitor) but less powerful. I confess:When I first heard about the new FreeStyle Libre from Abbott, before ever using it,I thought it sounded like a stupid product. However, your feedback is important to us. We are unable to collect your feedback at this time. Diabetes Product Review: Abbott Freestyle Libre
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