FDA Approves First Continuous Glucose Monitoring System for Insulin-Dosing Decisions

Lauren Santye, Assistant Editor
Published Online: Thursday, December 22nd, 2016
The FDA has approved the sole use of the Dexcom G5 continuous glucose monitoring system (CGM) to make insulin-dosing decisions without the need for additional finger-stick tests.

Patients with diabetes who use the Dexcom G5 CGM will be spared at least 3 to 4 finger sticks per day, according to the Chicago Tribune. Furthermore, they’ll only need 2 finger sticks per day (once every 12 hours) to ensure that the Dexcom CGM device is properly calibrated and providing accurate readings.

The device measures blood glucose levels by relying on a small sensor wire inserted below the skin to continuously monitor levels, and uses a transmitter worn on the skin to send information about blood glucose levels to a dedicated receiver and a compatible mobile device, such as a smartphone or a tablet, the Chicago Tribune reported.

If the blood glucose levels are too high or too low, the receiver and the mobile device will sound an alarm to alert patients.

“Although this system still requires calibration with 2 daily finger sticks, it eliminates the need for an additional finger-stick blood glucose testing in order to make treatment decisions,” said Alberto Gutierrez, director of the Office 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.”

The approval of the Dexcom G5 CGM to make treatment decisions was a result of 2 clinical trials that included 130 children with diabetes who were 2 years or older. There were no adverse events reported in either study.

“The FDA works hard to help ensure that novel technologies, which can reduce the burden of daily disease management, are safe and accurate,” Gutierrez said.

The Dexcom G5 is the first continuous glucose monitoring system to receive FDA approval for insulin-dosing decisions, according to the Chicago Tribune.

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