Dexcom G4 Platinum CGM Approved

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On October 5, the US Food and Drug Administration (FDA) announced the approval of the Dexcom G4 Platinum continuous glucose monitor (CGM), a fourth-generation device that builds on the technology of Dexcom’s previous CGMs.

The Dexcom G4 Platinum is composed of a sensor, a transmitter, and a monitor. The sensor, which is approximately the diameter of a human hair, is inserted under the skin of the abdomen, where it continuously monitors the glucose level of the interstitial fluid (the fluid between cells). These values are sent to the monitor via the transmitter every five minutes for up to seven consecutive days.

New features available on the Dexcom G4 Platinum include a sensor diameter that is 60% smaller, a 19% improvement in overall accuracy and a 30% improvement in accuracy when glucose levels are in the low range (less than 70 mg/dl), an option to set hypoglycemia (low blood glucose) alerts as low as 55 mg/dl, a sensor transmission range of up to 20 feet (compared to 5 feet in the previous CGM), customizable alerts with different tones, and a color LCD screen.

The LCD display screen shows a real-time graph of glucose patterns, including arrows indicating whether glucose levels are trending up or down and how fast they are changing.

“Improved accuracy in the critical hypoglycemic range is most important from a life-saving point of view. The Dexcom G4 PLATINUM fulfills the promise of CGM for people with diabetes by providing accurate and reliable real-time performance,” according to Dexcom CEO Terrance H. Gregg.

As noted in the Dexcom press release, the device is “covered by most insurance plans for people taking insulin.” The Dexcom G5 Platinum, which is available for order immediately, costs $1,198 for a starter kit before insurance, and a four-pack of sensors will cost $349. People who need assistance navigating the purchasing process can contact Dexcom at (888) 738-3646 for more information.

According to an article on Diabetes Mine, people who purchased a Dexcom CGM between September 1, 2012, and October 5, 2012, will be eligible for a free upgrade to the new device. Those who purchase a Dexcom CGM before August 31, 2012, that is still under warranty is eligible to upgrade for a one-time payment of $399.

To learn more about the Dexcom G4 Platinum continuous glucose monitor, read the FDA’s overview or see the Dexcom Web site (which includes a downloadable video tutorial illustrating how the device works).

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