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With Health Canada Approval, DexCom (DXCM) G5 Mobile CGM System Is The First And Only Medical Device In North America For Making Daily Diabetes Decisions Without Painful Fingersticks



11/14/2016 9:32:36 AM

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Landmark approvalmarks a new standard of care for managing diabetes and dosing insulin in Canada

BURNABY, British Columbia, Nov. 14, 2016 /PRNewswire/ -- 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.

DexCom, Inc.

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.


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