The system was originally approved to complement — not replace — fingerstick testing for diabetes treatment decisions. Now, patients can use the device as a replacement for finger prick tests, representing the first FDA-approved glucose monitoring system that can be used to inform diabetes treatment decisions without a confirmation fingerstick test.
The G5 Mobile Continuous Glucose Monitoring System features a small sensor wire — inserted just below the skin — that continuously measures and monitors glucose levels. Real-time data is sent wirelessly to an app on the patient’s cell phone, according to a news release from the FDA.
“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” said Alberto Gutierrez, PhD, director of theOffice of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their healthcare providers about the use of real-time continuous glucose monitoring in diabetes management.”
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