FDA Approves Continuous GMS for Adults

FDA www.fda.gov recently approved the first continuous glucose monitoring system for adults that does not require blood sample calibration. The “Free Style Libre Flash Glucose Monitoring System” made by Abbott Diabetes Care Inc., https://www.diabeteswcare.abbott will be used by adult patients to make diabetes treatment decisions without using a blood sample from the fingertip.

The system reduces the need for fingerstick testing by inserting a small sensor wire below the skin’s surface able to continuously measure and monitor glucose levels. Users can determine glucose levels by waving a dedicated mobile reader about the sensor wire to determine if glucose levels are too high, too low, or if and how the glucose levels are changing.

“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, for the Office of In Vitro Diagnostics and Radiological Health and Deputy Director of New Product Evaluation in FDA’s Center for Devices and Radiological Health.

The FDA evaluated data from a clinical study of individuals 18 years and older with diabetes, and reviewed the device’s performance by comparing readings obtained by the Free Style Libre Glucose Monitoring System to those obtained by an established laboratory method used to analyze blood glucose.

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