SAN DIEGO--(BUSINESS WIRE)--Dexcom, Inc., (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM), announced today that it has received U.S. Food and Drug Administration (FDA) approval for its CGM device: Dexcom G4® PLATINUM (Pediatric) for use in children ages 2 to 17 years with diabetes. Already approved for adults 18 and older, the Dexcom G4 PLATINUM (Pediatric) is now the only CGM system approved for children as young as two 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 kids 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 insulin to survive and frequent monitoring of their blood glucose levels.3
The Dexcom G4 PLATINUM tracks glucose levels continuously for 7 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 that notifies users when glucose levels fall to critically low levels for an additional level of awareness no other CGM brand offers.
Key features of the Dexcom G4 PLATINUM (Pediatric) include5:
- 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 in use today.
- Tiny sensor and wireless transmitter placed on the abdomen or upper buttocks in children ages 2-17 years that 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 is now approved for children ages 2-17 years, what is significant is the indication for young children ages 2-6 years, making the Dexcom G4 PLATINUM (Pediatric) the first CGM device approved for persons with diabetes in this age-range and the only CGM device that offers an alternate sensor wear site on the upper buttocks for added flexibility.
“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, MD, M.P.H., Chief of the Pediatric, Adolescent and Young Adult Section, Joslin Diabetes Center, in Boston, MA. “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.”
About Dexcom, Inc.
Dexcom, Inc., headquartered in San Diego, California, develops and markets continuous glucose monitoring systems for use by persons with diabetes, as well as blood glucose monitoring systems used by healthcare providers in hospital critical care settings. For more information on the Dexcom CGM, visit www.dexcom.com.
BRIEF SAFETY STATEMENT
The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (ages 2 to 17 years) with diabetes. CONTRAINDICATIONS: Remove the System before MRI, CT scan, or diathermy treatment. Taking acetaminophen while wearing the sensor may falsely raise your sensor glucose readings. WARNING: Do not use the System for treatment decisions. The System does not replace a blood glucose meter. In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decisions. In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have infection or inflammation. Report broken sensors to Dexcom Technical Support. The System is not approved for use in pregnant women or persons on dialysis. Sensor placement is not approved for sites other than under the skin of the belly or upper buttocks. Contact Dexcom Toll Free at 877-339-2664 or www.dexcom.com for detailed indications for use and safety information.
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 (http://www.diabetes.org/diabetes-basics/diabetes-statistics/)
5. Dexcom G4 PLATINUM (Pediatric) User Guide, 2013.