FDA Approves Pediatric Glucose Monitor

Dexcom Inc. has received U.S. Food and Drug Administration (FDA) approval for its Dexcom G4 Platinum continuous glucose monitoring (CGM) device for use in pediatric diabetics. Already approved for adults 18 and older, the Dexcom G4 Platinum (Pediatric) now is the only CGM system approved for children between 2 and 17 years old.

Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years.¹ The traditional standard-of-care for blood glucose measurement has been a blood glucose meter. CGM is important because it can help educate children on how to best learn to manage their diabetes into adulthood.

“We are thrilled with the FDA’s approval of our Dexcom G4 Platinum System in the pediatric population,” said Terrance H. Gregg, CEO of Dexcom. “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. 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.”

Diabetes affects 25.8 million Americans and is the seventh leading cause of death in the United States.² With diabetes, the body can’t produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. There are two types of diabetes—type 1 and type 2. Type 1 is more common in children and young adults. People with this form of diabetes require daily doses of insulin to survive and frequently must monitor their blood glucose levels.³

The Dexcom G4 Platinum 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 persons with diabetes to program personalized 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.⁴ The Dexcom G4 Platinum is the only CGM that comes with a built-in alarm to notify users when their glucose levels fall to critically low levels.
Key features of the Dexcom G4 Platinum (Pediatric) include:⁵

• An extended 20-foot wireless transmission range without obstruction for added flexibility.
• The Receiver measures less than half an inch thick and weighs 2.4 ounces, making the Dexcom G4 Platinum Receiver one of the smallest and lightest CGMs currently in use.
• Tiny sensor and wireless transmitter placed on the child’s abdomen or upper buttocks are simple to use and easy to wear.
• The only sensor available for use for up to seven days.
• Unlike blood glucose meter values, the Dexcom G4 Platinum CGM system displays where glucose levels are and whether they are trending up or down – helping the user to make informed choices about their diabetes management.

While the Dexcom G4 Platinum now is approved for children ages 2-17 years, its indication for youngsters aged 2-6 is significant because kids in this age range previously have not had a CGM product available to them, Dexcom executives said.

“Continuous glucose monitoring offers a unique opportunity for patients with diabetes to safely aim for glucose levels close to the reference range found in persons without diabetes,” said Lori Laffel, M.D., M.P.H., chief of the Pediatric, Adolescent and Young Adult Section, Joslin Diabetes Center, in Boston, Mass. “Glucose levels can change without warning; this device gives the user and their loved ones more dynamic information for optimal diabetes control, and it’s extremely user-friendly.”

Headquartered in San Diego, Calif., Dexcom develops and markets continuous glucose monitoring systems for diabetics, as well as blood glucose monitoring systems used by healthcare providers in hospital critical care settings. 

References

1. 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.
2. Centers for Disease Control and Prevention, 2011 National Diabetes Fact Sheet
3. National Diabetes Information Clearinghouse, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Diabetes Overview
4. American Diabetes Association
5. Dexcom G4 Platinum (Pediatric) User Guide, 2013.