WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration Tuesday expanded the approved use of Dexcom's G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes.
This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test.
The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions.
'The FDA works hard to help ensure that novel technologies, which can reduce the burden of daily disease management, are safe and accurate,' said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.
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