FDA Approves Dexcom Software with Artificial Pancreas Algorithm

November 3, 2014

Dexcom announced today that the U.S. Food and Drug Administration (FDA) has approved new software for the Dexcom G4^® PLATINUM CGM. The new Software 505 features the same advanced algorithm as used in artificial pancreas research around the world. The software will impact the performance of the Dexcom G4 PLATINUM, already considered the most accurate CGM system on the market today. The software will be made available free of charge to adult patients using the Dexcom G4 PLATINUM.

“Patients will be able to go online and download the software, or they will receive the software preloaded onto their Dexcom receiver with new orders,” said Terrence Gregg, CEO, Dexcom. “This latest software enhancement to the Dexcom G4 Platinum will make the performance level comparable to episodic blood glucose finger sticks; this is a significant step in the evolution of CGM becoming the standard-of-care over blood glucose meters for people with diabetes.”

Now, Dexcom G4 PLATINUM is the first and only CGM system on the market with a single-digit MARD (Mean Absolute Relative Difference) measurement, below 10 percent. MARD is the standard industry measurement of accuracy, where a lower MARD reflects higher accuracy. With the new software, healthcare providers, patients and caregivers will now have glucose readings from a sensor that are closest yet to lab accuracy. The combination of the new software with the CGM advantages of real-time trends, speed and direction provides a complete picture of the patient’s glucose activity.

Diabetes affects 29.¹ million Americans and is the 7th leading cause of death in the United States.³ With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. It is estimated that approximately 79 million Americans over the age of 20 are at risk for developing diabetes, largely due to obesity, physical inactivity and poor diet.² People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.^4,5

References:

Do not use the Dexcom G4® PLATINUM for treatment decisions
Clarke SF and Foster JR. A history of blood glucose meters and their role in self-monitoring of diabetes mellitus. Br J Biomed Sci. 2012;(3)2:83-93.
Centers for Disease Control and Prevention. National Diabetes Statistics Report: Estimates of Diabetes and Its Burden in the United States, 2014. Atlanta, GA: US Department of Health and Human Services; 2014. http://www.cdc.gov/diabetes/pubs/statsreport14.htm. Updated July 28, 2014. Accessed August 12, 2014.
Hyperglycemia (High blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html. Updated August 5, 2013. Accessed December 3, 2013.
Hypoglycemia (Low blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html. Updated July 16, 2013. Accessed December 3, 2013.