DexCom has received the US Food and Drug Administration (FDA) approval for its continuous glucose monitoring device, Dexcom G4 Platinum (Paediatric) for use in children aged between two and 17 years with diabetes.
The G4 Platinum system, which monitors blood glucose levels in people with diabetes, had earlier been approved for patients ages 18 and older.
It is the first approved CGM system for use in patients aged two to 17 years. It involves the upper buttock in addition to the abdomen as sensor insertion sites. The device system components (sensor and transmitter) are unmodified from the previous system.
The G4 Platinum system is an externally worn system that continuously displays an estimate of blood glucose levels and the direction and rate of change of these estimates.
The device tracks glucose levels continuously for seven days throughout the 24-hour period using wireless technology, enabling users to view their glucose levels on-demand.
The system allows people with diabetes to programme personalised information such as glucose targets and alerts, and it has an alarm feature to alert the user if glucose levels rise or fall to dangerous levels. This is important as uncontrolled glucose can cause health complications and even death.
Unlike blood glucose meter values, the Dexcom CGM system comes with a built-in alarm that notifies users when glucose levels fall to critically low levels for an additional level of awareness.
The Dexcom G4 Platinum Receiver is one of the smallest and lightest CGMs in use and has the only sensor available for use for up to seven days.
Dexcom CEO Terrance H Gregg said the company is thrilled with the FDA’s approval of its Dexcom G4 Platinum system in the paediatric population.
"Daily management is relentless, and parents can now have greater peace of mind that a child’s diabetes is under control, whether the child is at home, away at school, or participating in activities or sports," Gregg said.
"The Dexcom G4 PLATINUM provides dynamic glucose information harnessing today’s most innovative technology, so that persons with diabetes can go about their daily lives without added worry."
According to GlobalData estimates, the glucose monitoring market was valued at $4.41bn in 2012 and is expected to grow at a CAGR of 4.3% to reach $5.94bn by 2019.