Now Children Can Gain Better Control of Their Diabetes with Advanced CGM Technology
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
Diabetes affects 25.8 million Americans and is the seventh leading cause
of death in
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:
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
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.
3. National Diabetes Information Clearinghouse,
5. Dexcom G4 PLATINUM (Pediatric) User Guide, 2013.
Green Room PR
Caren Begun, 201-396-8551
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