Dexcom G5 Mobile CGM Approved for Insulin Dosing

The U.S. Food and Drug Administration (FDA) recently approved, for the first time, the use of a continuous glucose monitor (CGM) as a replacement for traditional fingerstick monitoring to determine insulin dosing in people two years of age and older with diabetes.

Dexcom’s G5 Mobile Continuous Glucose Monitoring System was previously approved only as a complement to traditional blood sugar monitoring, with the FDA requiring treatment decisions be made based on readings from conventional blood glucose tests. With the expanded indication, users will be able to make their insulin dosing calculations based on the readings provided by the CGM. (Two fingerstick tests will need to be performed each day to calibrate the device.)

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The Dexcom G5 Mobile is composed of a sensor, a transmitter, and either a compatible mobile device, such as a smartphone or tablet, or a receiver. The sensor is inserted under the skin, where it continuously monitors the glucose level of the interstitial fluid (the fluid between cells). These values are sent to the mobile device or receiver via the transmitter every five minutes.

The approval of the Dexcom G5 Mobile for this expanded use follows the advice of an FDA advisory panel, which voted 8 to 2 in July in favor of the new indication. The decision was based on results from two studies including 130 adults and children ages two and up that compared readings from the device to conventional blood glucose readings.

“Although this system still requires calibration with two daily fingersticks, it eliminates the need for any additional fingerstick blood glucose testing in order to make treatment decisions,” notes Alberto Gutierrez, PhD, 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.”

Due to its approval as a “therapeutic” device, or a system off which treatment decisions can be based, the Centers for Medicare & Medicaid Services (CMS) has announced coverage for the Dexcom G5 Mobile, with the procedure to process claims set to begin within the next couple of months.

For more information about using the Dexcom G5 Mobile CGM for treatment decisions, see the article “FDA Okays Use of Dexcom G5 CGM for Insulin Dosing” on Medscape or the press release on the FDA website. And to learn more about the Dexcom G5 Mobile, visit the Dexcom website.

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