FDA Authorizes Marketing of the New Dexcom G6® CGM Eliminating Need for Fingerstick Blood Testing for People with Diabetes
March 27 2018 - 4:45PM
Business Wire
Unprecedented De Novo request for Dexcom G6®
will pave the way for the company to bring even more rapid
innovation to market
Management will host an investor conference
call at 8:00 A.M. Eastern Time on Wednesday, March 28, 2018
DexCom, Inc. (NASDAQ:DXCM), the leader in continuous glucose
monitoring (CGM) is pleased to announce that the U.S. Food and Drug
Administration (FDA) has granted a De Novo request for the Dexcom
G6® CGM System, the newest generation of CGM for people with
diabetes ages 2 and up. The Dexcom G6 is indicated by the FDA for
use as both a standalone CGM and for integration into automated
insulin dosing (AID) systems. The powerful and revolutionary new
Dexcom G6® is the first CGM to receive this classification by the
FDA.
Along with this authorization, the FDA is establishing criteria,
called special controls, which outline requirements for assuring
CGM accuracy, reliability and clinical relevance as well as
describe the type of studies and data required to demonstrate
acceptable CGM performance.
“As a factory-calibrated, real-time CGM system with exceptional
accuracy, the Dexcom G6® will be transformative for people with
diabetes, who will no longer be required to prick their fingers for
diabetes management,” said Daniel DeSalvo, MD, Pediatric
Endocrinologist at Texas Children’s Hospital in Houston, Texas. “I
can tell you as someone who has Type 1 Diabetes myself, with all of
its features and benefits, the Dexcom G6® is the CGM device I have
been anticipating for the last twenty years. This CGM system will
help to alleviate the burden of diabetes management while improving
the lives of people with diabetes.”
New with Dexcom G6®:
- Fingerstick Elimination – No
fingersticks are needed for calibration or diabetes treatment
decisions.
- Easy Sensor Applicator –
Complete redesign of the sensor applicator allows for one-touch,
simple insertion.
- Discreet and Low Profile – A
redesigned transmitter with a 28% lower profile than previous
generation Dexcom CGMs makes the device comfortable and easy to
wear under clothing.
- Acetaminophen Blocking – New
feature allows for more accurate glucose readings with no
medication interference.
- Predictive Low Alert – New alert
feature predicts hypoglycemia before it hits to help avoid
dangerous low blood sugar events.
- Extended 10-Day Sensor – 10-day
sensor allows for 43% longer wear than previous generation Dexcom
CGMs.
Dexcom G6® carries forward important features of Dexcom CGM
systems:
- Continuous Glucose Readings –
Automatically sends glucose readings to a Dexcom receiver or
compatible smart device every five minutes.
- Mobile App and Sharing –
Compatibility with smart device apps allows for sharing glucose
information with up to five people for added support.
- Customizable Alarms and Alerts –
Personalized alert schedule immediately warns the wearer of pending
dangerous high and low blood sugars.
“Contemporary diabetes technology relies on accuracy and
performance, which Dexcom has proven over time. Once again, Dexcom
has earned the trust of the research community all over the world,”
said Boris Kovatchev, PhD and founding director of the UVA Center
for Diabetes Technology. “Innovations like the Dexcom G6® are
critical to closing the loop – automated insulin delivery known as
the ‘artificial pancreas’.”
"We listen closely to people with diabetes and continuously look
for ways to empower them to better manage their condition. The
FDA’s special controls set a rigorous, new standard in our industry
and clearly define the process by which other CGM systems may be
approved,” said Kevin Sayer, Chief Executive Officer of Dexcom. “We
believe the new Dexcom G6® is a significant step forward for Dexcom
and our industry.”
The company expects to launch later this year. For more
information, visit www.dexcom.com/G6.
Conference Call
The company will host a conference call at 8:00 A.M. Eastern
Time on Wednesday, March 28, 2018. To listen to the conference
call, please dial (888) 771-4371 (US/Canada) or (847) 585-4405
(International) and use the confirmation number "46726870"
approximately five minutes prior to the start time.
About CGM
CGM devices are considered the most significant breakthrough in
diabetes management in the past 40 years1 and Dexcom has been a
leader of those innovations. Diabetes affects nearly 30 million
Americans and is the seventh leading cause of death in the United
States2. The traditional standard-of-care for glucose monitoring
has been a fingerstick meter, which is painful as some patients
needed to test their blood up to 12 times a day. 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 levels are too low or too high.
People with diabetes who take insulin must monitor their blood
glucose levels frequently. Uncontrolled glucose can cause health
complications and even death3,4. To learn more about CGM, visit
www.dexcom.com.
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.
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. 2014 National Diabetes Statistics Report.
Centers for Disease Control and Prevention.
http://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf
Accessed March 31, 2015.3. 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, 2013.4. 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.
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for DexCom, Inc.INVESTOR CONTACT:Steve Pacelli,
858-200-0200orPRESS CONTACT:James McIntosh, 619-884-2118
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