FDA Approves Dexcom G5® Mobile Continuous Glucose Monitoring System
August 25 2015 - 8:30AM
Business Wire
First and Only Fully Mobile CGM System Allows
Adults and Children as young as 2 years old to Conveniently and
Discreetly Monitor and Share Glucose Levels
Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose
monitoring (CGM) for patients with diabetes, announced today that
the U.S. Food and Drug Administration (FDA) has approved the Dexcom
G5® Mobile Continuous Glucose Monitoring (CGM) System. With
wireless Bluetooth® technology built into the device transmitter,
the G5 Mobile CGM System is the first and only fully mobile CGM
system approved by the FDA for both adults and children as young as
2 years of age that sends glucose data directly to a smartphone,
freeing users from the need to carry a separate receiver. The new
transmitter securely sends vital glucose information directly to an
app on iOS-enabled devices for real-time diabetes management.
Android applications will follow early next year. Like its
predecessor, the G4 PLATINUM CGM with Share, users can also select
up to five designated recipients, or "followers." These followers
can remotely monitor a patient's glucose information and receive
alert notifications from almost anywhere.
“Dexcom is rapidly advancing technology for continuous glucose
monitoring devices to improve diabetes management. Since January,
the company has introduced the G4 PLATINUM CGM with Share, apps to
enable the first CGM on the Apple WatchTM and now the Dexcom G5®
Mobile CGM. These advances are making diabetes management more
convenient and flexible than ever before,” stated Kevin Sayer,
President and Chief Executive Officer of Dexcom. “We are excited
for the promise this new technology holds for patients and
caregivers.”
About the Dexcom U.S. G5 Mobile Launch
- The G5 Mobile system is anticipated to
begin shipping in late September 2015.
- All purchasers of a G4 Platinum with
Share system from August 1, 2015, until the G5 Mobile system is
shipped, will be eligible to receive a no-cost upgrade to the G5
Mobile system.
- There will be a low cost cash upgrade
to the G5 Mobile system for those patients who are still under
warranty with their existing system.
“Obviously there are a lot of moving parts to our commercial
launch plans given this sooner-than-expected approval, and the
financial ramifications, such as inventory adjustments and revenue
recognition policies are being evaluated and will be discussed in
detail on the Q3-2015 earnings call in early November,” remarked
Sayer.
Enhanced Mobility and Flexibility
Available by prescription, the Dexcom G5 Mobile CGM System
features the most accurate glucose sensor on the market while
providing enhanced mobility and flexibility to view and share
personal glucose data and trends. The only CGM with single digit
MARD (Mean Absolute Relative Difference), the Dexcom G5 Mobile
comes with the longest-wear sensor on the market and features
customizable alerts and a built-in low glucose alarm (55 mg/dL
alarm) to warn patients of highs and lows and how quickly they may
be happening through a simplified mobile interface. Data from the
Dexcom G5 Mobile can be integrated with Dexcom CLARITYTM, a
Cloud-based reporting software, for personalized,
easy-to-understand analysis of trends that may improve diabetes
management.
Continuous glucose monitoring is considered the most significant
breakthrough in diabetes management in the past 40 years.1 The
traditional standard-of-care for glucose (blood sugar) monitoring
has been a finger stick meter. CGM augments the use of glucose
meters for the management of diabetes. Meters are still required to
calibrate CGMs and for guidance in making therapy and meal
decisions. 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.
Diabetes affects 29.1 million Americans and is the 7th leading
cause of death in the United States.2 With diabetes, the body
cannot produce or use the hormone insulin effectively, causing a
buildup of glucose, or sugar, in the blood. It is estimated that
approximately 86 million Americans over the age of 20 years old are
at risk for developing diabetes (primarily Type 2), largely due to
obesity, physical inactivity and poor diet.2 People with diabetes
who take insulin must monitor their blood glucose levels
frequently. Uncontrolled glucose can cause health complications and
even death.3,4
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.
Cautionary Statement Regarding Forward Looking
Statements
This press release contains forward-looking statements that are
not purely historical regarding Dexcom’s or its management’s
intentions, beliefs, expectations and strategies for the future,
including those relating to the intended use and technical
specifications of the CGM products, the potential impact on
outcomes associated with diabetes care. Because such statements
deal with future events, they are subject to various risks and
uncertainties, and actual results could differ materially from
Dexcom’s current expectations. Factors that could cause actual
results to differ materially include risks and uncertainties such
as those relating to: the inability to successfully development new
products and obtain regulatory approval; a lack of acceptance in
the marketplace by physicians and patients; the inability to
manufacture products in commercial quantities at an acceptable
cost; possible delays in the company's development programs; the
inability of patients to receive reimbursement from third-party
payors; and inadequate financial and other resources. Certain of
these risks and uncertainties, in addition to other risks, are more
fully described in the section entitled “Risk Factors” in Dexcom’s
Annual Report on Form 10-K, its most recent Quarterly Report on
Form 10-Q, and its other reports filed with the Securities and
Exchange Commission.
To view multimedia assets, please visit: http://www.dexcom.com/media.
References
- 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.
- 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.
- 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 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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version on businesswire.com: http://www.businesswire.com/news/home/20150825005455/en/
Dexcom, Inc.Media Contact:Caren
Begun, 201-396-8551orInvestor Contact:Steven Pacelli,
858-200-0200
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