FDA Approval of Dexcom's Non-Adjunctive Indication Triggers a New Era in Diabetes Management
The Dexcom G5 Mobile CGM System is the first and only medical device
that is FDA-approved for making daily diabetes decisions without painful
SAN DIEGO--(BUSINESS WIRE)--
Dexcom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring
(CGM) for patients with diabetes, announced today that the U.S. Food and
Drug Administration (FDA) has approved its G5 Mobile CGM system as the
first and only continuous glucose monitoring system that can be used to
make daily diabetes treatment decisions without finger pricking. The new
"non-adjunctive" indication expands use of the Dexcom G5 Mobile CGM
system as a replacement to finger stick glucose testing for diabetes
treatment decisions, positioning the device as the new standard of care
in glucose monitoring for diabetes management. With the new label
indication, the Dexcom G5 CGM System only requires two finger pricks per
day for calibration.
"The expanded indication for the Dexcom G5 Mobile CGM system is an
astounding milestone for people with diabetes and it is a critical step
to advancing diabetes technology that will drastically change diabetes
management," said Kevin Sayer, Dexcom President and Chief Executive
Officer. "Now, people with diabetes who use the Dexcom G5 Mobile CGM
system can make daily treatment decisions without having to perform
confirmatory finger sticks. And basing their treatment decisions on a
number, accompanied by information on speed and direction from the CGM,
will greatly improve their decisions over the information provided by
blood glucose meters."
In July, an FDA selected panel of experts determined that the Dexcom G5
Mobile CGM system is safe, effective and the benefits outweigh the risks
with the proposed indications for use. The FDA has followed the expert
recommendation and made the Dexcom G5 Mobile CGM system the first and
only CGM system in the U.S. to have a non-adjunctive designation.
Dexcom's CGM system is widely recognized as the most accurate and most
popular CGM in the world.
"This approval is truly momentous for people like me with diabetes as we
can now go up to 12 hours without a painful finger prick, we don't have
to carry a glucose meter everywhere we go, and we can make treatment
decisions without lancing our fingers," said Steven Edelman, MD, Founder
and Director, Taking Control of Your Diabetes. "It completely changes
the way that we manage our diabetes and gives us a chance to gain much
better control of the disease without all of the pain and hassle of
constant finger sticks."
The approval is also the first step toward enabling people 65 and older
with Medicare to access CGM, as non-adjunctive labeling is a requirement
for Medicare coverage.
About Diabetes and Continuous Glucose Monitoring
With diabetes, the body cannot produce or use the hormone insulin
effectively, causing a buildup of glucose, or sugar, in the blood.
People with diabetes who take insulin must monitor their blood glucose
levels frequently. Uncontrolled glucose can cause health complications
and even death.i,ii
Continuous glucose monitoring (CGM) is considered the most significant
breakthrough in diabetes management in the past 40 years.iii
CGM is important because, in addition to providing the glucose level, it
provides the direction and rate of glucose change with the push of a
button and alerts users when glucose is too low or too high with
built-in and customizable alarms. A recent study showed that after one
year, patients with type 1 diabetes who used CGM alone had significant
A1C reductions regardless of the type of insulin delivery method used,
including insulin pumps.iv
About DexCom, Inc.
Dexcom, Inc., headquartered in San Diego, CA, is dedicated to helping
people better manage their diabetes by developing and marketing
continuous glucose monitoring (CGM) products and tools for adult and
pediatric patients. With exceptional performance, patient comfort and
lifestyle flexibility at the heart of its technology, users have
consistently ranked Dexcom highest in customer satisfaction and loyalty.
For more information on the Dexcom CGM, visit www.dexcom.com.
*A minimum of two finger sticks per day are still required to calibrate
the CGM system.
i Hyperglycemia (High blood glucose). American Diabetes
Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html.
Updated August 5, 2013. Accessed December 3, 2013.
ii Hypoglycemia (Low blood glucose). American Diabetes
Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html.
Updated July 16, 2013. Accessed December 3, 2013.
iii Clarke SF and Foster JR. A history of blood glucose
meters and their role in self-monitoring of diabetes mellitus.
J Biomed Sci. 2012;(3)2:83-93.
iv J. Soupal, J. Skrha Prazny, M. Flekac, L. Petruzelkova, J.
Skrha, et al. Comparison of different treatment modalities for Type 1
diabetes including Sensor-Augmented Insulin Regimens (SAIR), in 52 weeks
of follow ups: A COMISAIR Study. Diabetes Technology and Therapeutics.
Vol 18, No. 9, Sept. 2016.
View source version on businesswire.com: http://www.businesswire.com/news/home/20161220005992/en/
Caren Begun, 201-396-8551
Steve Pacelli, 858-200-0200
Source: Dexcom, Inc.
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