New FDA-Approved Diabetes Device Means Less Fingerstick Tests

Here’s a bit of good news for diabetics: the fingerstick test could be a thing of the past.

The U.S. Food and Drug Administration recently decided that the Dexcom G5 continuous monitoring system can help replace the finger-stick method in determining insulin dosages.

Previously, the monitoring system was used as a complement to fingersticking for diabetes treatment. The Dexcom G5 is the first FDA-approved continuous monitoring system that can be used without fingersticking.

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“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.

The system, however, still requires calibration with two fingersticks each day, Gutierrez adds. But it does eliminate the need for fingerstick testing to make treatment decisions.

“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,” Guiterrez said.

Using a small sensor wire, which is inserted just below the skin, glucose levels are measured throughout the day through fluid under the skin. Real-time results are sent wirelessly to an app on a mobile device  – such as a smartphone or tablet.

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Patients then have the option of setting custom alerts and alarms for times when glucose levels are low or high.

Before its decision to approve the monitoring system, the FDA analyzed two studies including 130 adults and children with diabetes. There were no adverse affects during the studies.

With more than 29 million people living with diabetes in the U.S., the new monitoring system is sure to bring more accuracy to insulin dosages and meal management through the day.