The U.S. Food and Drug Administration (FDA) recently approved the first continuous glucose monitoring system able to substitute for traditional fingerstick blood glucose (sugar) testing in diabetic patients over age 2, from Silver Spring, Maryland.
Until now, the G5 Mobile Continuous Glucose Monitoring System manufactured by San Diego-based Dexcom was authorized to supplement fingerstick testing without actually replacing it.
Dexcom’s G5 system works by using a small wire sensor inserted just underneath the skin to monitor glucose levels continuously. Real-time data is conveyed regularly to a mobile application, with built-in alerts for levels that vary too widely from the user’s baseline.
While effective usage still requires two fingerstick tests daily, this eliminates the need for extra sticks.
Alberto Gutierrez, who directs the FDA’s Office of In Vitro Diagnostics and Radiological Health in Maryland, clarified that -- while the product will help reduce repeated rounds of fingerstick testing -- it will not replace it entirely.
“(It) eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” Gutierrez said. “This may allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their health care providers about the use of real-time continuous glucose monitoring in diabetes management.”
