Feb 22, 2019   SOURCE: PR NewsWire

Dexcom G6® CGM System Receives Health Canada Approval

VANCOUVER, Feb. 22, 2019 /CNW/ - Dexcom, Inc. (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM), today announced that the company has received Health Canada approval for its next generation Dexcom G6 CGM System for people with diabetes ages two years and up.

This approval now clears the way for the Dexcom G6 to be made available to Canadians with diabetes. It was previously introduced into the U.S, U.K., Ireland, and several other European countries and has seen strong sales. The G6 commercial launch in Canada is planned for late 2019 as the company continues to build capacity to support global launch plans.

"The Dexcom G6 represents another step forward in diabetes management," said Paul Flynn, Vice President, Dexcom Canada, Inc. "This next generation product continues the performance, features, and accuracy that the diabetes community has come to expect from Dexcom CGM. We're proud and excited to be able to bring it to Canadians this year, once we're in a position to reliably meet demand."

The G6 has a new transmitter, a new sensor with new auto-applicator, and a new touchscreen receiver (which is an optional display device for Dexcom CGM). These new components share and build upon the core attributes of the currently available Dexcom G5 Mobile CGM technology platform:

    --  No fingersticks for diabetes treatment decisions*
    --  Continuous glucose readings sent automatically to any compatible smart
        device** (or a Dexcom receiver), using Bluetooth technology
    --  Customizable alerts and alarms to warn users of dangerous glucose
        levels, even while they are asleep - a particularly useful feature for
        those with glucose variability and impaired hypoglycemia awareness
    --  Real-time data sharing with up to five Followers(***), allowing
        authorized others to view the user's glucose levels remotely

More information about Dexcom and how to get started with continuous glucose monitoring can be found at www.dexcom.com.

About Dexcom G5 Mobile & Dexcom G6 CGM Systems
The Dexcom G5 Mobile and Dexcom G6 are stand-alone CGM systems for people with diabetes on multiple daily injection therapy (primarily the Type 1 diabetes population) and can also be used by anyone on insulin pump therapy. They are also the only CGM systems with accuracy approved for the user to make diabetes treatment decisions (such as insulin dosing) without the need for a fingerstick*. With both Dexcom G5 & G6 CGM Systems, a Sensor is inserted under the skin to measure the level of glucose in the interstitial fluid (fluid in the tissue). A Transmitter is attached to the Sensor, sending glucose readings continuously to a Receiver or compatible smart device**. The life of the Transmitter is 90 days, so any Dexcom G5 user is only ever 90 days away from the latest generation of technology, once it becomes available.

About CGM
CGM devices are considered the most significant breakthrough in diabetes management in the past 40 years(1) and Dexcom has been a leader in bringing such innovations to patients with diabetes. Type 1 diabetes affects nearly 300,000 Canadians((2)). The traditional standard for glucose monitoring has been a blood glucose meter, requiring the user to perform painful fingersticks each time they wish to get a reading. CGM not only diminishes the burden of routine fingersticks, but beyond just getting a glucose level number, CGM also provides the direction and rate of glucose change at a glance - and alerts users when glucose levels are too low or too high. This is especially significant at night. People with diabetes who take insulin must monitor their glucose levels frequently. Uncontrolled glucose can cause health complications and even death((3))(,)((4)). To learn more about CGM, visit www.dexcom.com.

About DexCom, Inc.
DexCom, Inc. is headquartered in San Diego, CA, and has operations in Canada. It 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 Dexcom G5 Mobile and Dexcom G6, you should perform
      a fingerstick to confirm your blood glucose level if
      your glucose alerts and readings do not match your
      symptoms or expectations.  With Dexcom G5 Mobile, you
      should also confirm your glucose level if you are taking
      medications containing acetaminophen, and two
      fingersticks a day are required for calibration.


     **To view a list of compatible devices, visit
      www.dexcom.com/compatibility


     ? Following requires the Dexcom Follow app and an
      internet connection.




                (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 Canadian Diabetes Association. The prevalence and costs
                 of diabetes. December 2009.


                (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.

SOURCE Dexcom, Inc.