FDA expands approval for CGM system

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Friday, December 23, 2016

SAN DIEGO – Dexcom has received expanded approval from the U.S. Food and Drug Administration for the G5 mobile continuous glucose monitoring system.

This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation from a traditional fingerstick test. The system was previously approved to complement, not replace, fingerstick testing for diabetes 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,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in a statement.

The G5 uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels. Real-time results are sent wirelessly every five minutes to a dedicated receiver and a mobile app. Alarms and alerts indicate glucose levels above or below user-set thresholds.

The system must be calibrated at least two times daily using blood obtained from fingerstick tests; however, additional daily fingerstick blood tests are no longer necessary.

The FDA evaluated data from two clinical studies of the G5 system, including 130 adults and children age 2 and older with diabetes. All studies included a seven-day period where system readings were compared to blood glucose meter values, as well as to a laboratory test method that measures glucose values. No serious adverse events were reported during the studies.