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
SAN DIEGO--(BUSINESS WIRE)--Mar. 27, 2018--
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
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
- Mobile App and Sharing – Compatibility with smart device apps
allows for sharing glucose information with up to five people for
- Customizable Alarms and Alerts – Personalized alert schedule
immediately warns the wearer of pending dangerous high and low blood
“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,
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
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.
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.
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.
Hypoglycemia (Low blood glucose). American Diabetes Association Web
Updated July 16, 2013. Accessed December 3, 2013.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180327006343/en/
Source: DexCom, Inc.
for DexCom, Inc.
Steve Pacelli, 858-200-0200
James McIntosh, 619-884-2118