The US Food and Drug Administration (FDA) has cleared Dexcom's new continuous glucose monitoring (CGM) system.
The G4 PLATINUM system comprises a tiny sensor which is inserted by the user under the skin on the abdomen and a transmitter that sends data wirelessly to a sleek and small LCD monitor.
The system provides data every 5 minutes for up to 7 consecutive days, and easily shows the body’s response to medication, food and exercise.
In addition, the new system provides an in-motion picture that shows not only glucose levels, but also the speed and direction in which it is moving, and alerts the user to sudden changes so they can take action.
Clinical trials of G4 PLATINUM demonstrated approximately 19% improvement in overall accuracy and approximately a 30% improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl).
Dexcom CEO Terrance Gregg said 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," Gregg added.