Landmark approval marks a new standard of care for
managing diabetes and dosing insulin in Canada
BURNABY, British Columbia,
Nov. 14, 2016 /CNW/ -- Dexcom,
Inc. (NASDAQ: DXCM), the leader in continuous glucose monitoring
(CGM) for patients with diabetes, announced today that Health
Canada has approved its Dexcom G5 Mobile CGM system for
"non-adjunctive" use by people with diabetes aged 2 years and
older.
The "non-adjunctive" indication enables the use of the Dexcom G5
Mobile CGM system as a replacement to fingerstick glucose testing
for diabetes treatment decisions, making it a significant new
standard of care in diabetes management. This approval means that
diabetes patients and their physicians can now make treatment
decisions based on data reported by the Dexcom G5 Mobile CGM system
alone, without the use of painful fingersticks associated with
blood glucose meters (fingersticks are only needed every 12 hours
to calibrate). With wireless Bluetooth® technology built into
the device transmitter, the G5 Mobile CGM System is the first and
only fully mobile CGM system that sends glucose data directly to a
smart device, freeing users from the need to carry a separate
receiver. The device transmitter securely sends vital glucose
information every five minutes directly to an app on iOS-enabled
devices for real-time diabetes management. Users of the system can
also select up to five designated recipients, or "followers" so
they can remotely monitor the user's glucose information and
receive alert notifications for added protection and peace of
mind.
"News of the Canadian launch of the Dexcom G5 Mobile CGM System
is truly exciting. CGM technology allows people with diabetes
to view real time glucose data and trends, and the built-in alarms
allow for intervention by the user to minimize the risk of
hypoglycemia and hyperglycemia. It has become an invaluable
component of diabetes management, especially for pediatric
patients," said Dr. Angelo Simone,
Pediatric Endocrinologist, Trillium Health Partners, Assistant
Professor, Department of Pediatrics, University of Toronto. "As a Pediatric
Endocrinologist I look forward to being able to review my patient's
glucose data even before the family arrives in clinic."
"As a country singer, a pilot and a person living with diabetes,
I benefit tremendously from the glucose readings that I get every 5
minutes from my Dexcom CGM," says George Canyon, Canadian Country
singer and type 1 diabetic. "Now, seeing my glucose levels on my
phone will enable me to manage my diabetes even better and do all
the things that I love most without the inconvenience and pain of
fingerstick testing multiple times a day, it's like a whole
new world."
Before the landmark approval by Health Canada, the Dexcom system
could only be used to augment glucose meter fingerstick testing.
Canada is the first country in North America to approve the device with the
non-adjunctive indication as a U.S. Food and Drug Administration
(FDA) Advisory Panel voted in favor of granting a non-adjunctive
claim in the U.S. this summer but a final FDA decision is still
pending.
"The new indication in Canada
for the Dexcom G5 Mobile CGM system is an astounding milestone for
people with diabetes and is a critical step forward for advancing
diabetes technology to drastically change diabetes management,"
said Kevin Sayer, Dexcom President
and Chief Executive Officer. "Now, people with diabetes in
Canada who use the Dexcom G5
Mobile CGM system can make treatment decisions without having to
perform multiple fingersticks daily, which has posed a significant
barrier to properly managing diabetes in the past."
The Dexcom G5 Mobile CGM System will be available within the
first three months of 2017.
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, and has
operations in Canada, 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.v For more information on the Dexcom CGM,
visit www.dexcom.com.
CONSUMER CONTACT:
Caren Begun, 201-396-8551
INVESTOR CONTACT:
Steve Pacelli, 858-200-0200
References
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.
Br 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.
v dQ&A research, 2009-2016
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SOURCE Dexcom, Inc.