Innovative Dexcom G4® PLATINUM Continuous Glucose Monitor (CGM) Receives FDA Approval for Use in Children Ages 2 to 17 Years
February 03 2014 - 5:57PM
Business Wire
Now Children Can Gain Better Control of Their
Diabetes with Advanced CGM Technology
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.
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
(http://www.diabetes.org/diabetes-basics/diabetes-statistics/)
5. Dexcom G4 PLATINUM (Pediatric) User Guide, 2013.
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