Dexcom G4 Platinum Continuous Glucose Monitor Approved by FDA

Continuous glucose monitors (CGMs) are devices for people with diabetes that provide continuous, “real-time” readings and the trend of their blood sugar levels. This can allow people with diabetes to understand both their current blood sugar level and whether it is rising or falling, providing better information to intervene by eating food or taking insulin to prevent it from going too high or too low. To date, CGMs from three companies have been approved by the FDA, and a major clinical trial funded by JDRF has found that people with T1D who use a CGM experience significant improvements in blood sugar control. In October 2012, the U.S. Food and Drug Administration approved a new CGM system, called the Dexcom G4™ PLATINUM. Clinical trials report up to a 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the previous generation, Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (when blood sugar is less than 70 mg/dl). The additional features include customizable alerts with specific tones, “hypo alert” setting at 55 mg/dl, and up to a 20-foot transmission range.

Ramifications for Individuals with T1D:

CGM devices have been shown to help people with diabetes achieve better glucose control. This device improves on currently available technology, providing more accuracy, a better form-factor and a longer transmission distance. These features should provide a better user experience with the CGM. With more accurate blood sugar level information, especially in the hypoglycemic range, individuals with T1D will be able to achieve better control of their T1D.

JDRF Involvement:

JDRF was not involved with the development of Dexcom G4 CGM system but remains committed to improving the accuracy of CGM systems.

Investigators and Institutions:

Dexcom, Inc., San Diego, California

Reference:

U.S. Food and Drug Administration website, Device Approvals and Clearances, Dexcom G4 PLATINUM Continuous Glucose Monitoring System – P120005