Dexcom G6® CGM System Receives CE Mark
June 12 2018 - 7:00AM
Business Wire
Revolutionary new CGM system eliminates routine
fingersticks for people with diabetes and is nearly one-third
smaller than previous generation
Dexcom, Inc. (NASDAQ:DXCM), a leader in continuous glucose
monitoring (CGM), announced today that the company has received CE
Mark for its Dexcom G6 System for people with diabetes ages two
years and up.
“The Dexcom G6 represents the future of diabetes management. Not
only does the product eliminate the need for fingersticks, but it
also maintains the performance, connectivity and accuracy that the
diabetes community has come to expect from Dexcom CGM,” said John
Lister, Dexcom’s General Manager for EMEA.
The groundbreaking Dexcom G6 will be available in the U.K. and
Ireland this month and is expected to be introduced into other
European countries later this year. Dexcom G6 encompasses new
features that empower users to take control of their diabetes:
- Elimination of fingersticks for
calibration or diabetes treatment decisions
- Customisable alarms and alerts to warn
users and their designated followers of dangerous glucose levels,
even while they are asleep – a particularly useful feature for
children and those with impaired hypoglycaemia awareness
- An extended 10-day sensor allowing
for 43% longer wear than the previous generation Dexcom CGM
- A new and smaller transmitter with a
28% lower profile than the previous generation system
- An auto-applicator designed to make
sensor insertion very simple and as painless as possible with the
touch of a button
- Continuous glucose readings sent
automatically using Bluetooth technology to any compatible smart
device, or to a Dexcom receiver, at five-minute intervals
- New sensor membrane that enables
Paracetamol use without any effect on glucose readings
Furthermore, with the Dexcom G6 app, users can share their
glucose information with up to five people. Whether you are a
parent of a child with diabetes or an independent adult, the G6
lets you seamlessly keep track of glucose levels and enables the
user’s care team to remotely monitor their loved ones for extra
peace of mind.
Nick Oliver, from the Imperial College London, comments: “For
many years, fingerstick blood glucose testing has been a critical
component of diabetes self-management. However, the
self-monitoring, which can sometimes mean testing blood up to ten
or more times a day, can be time-consuming, painful and difficult
to fit into a busy day. The Dexcom G6 presents a major advancement
for the continuous glucose monitoring category. With Dexcom G6,
people with diabetes now have the freedom to live without routine
fingersticks and can rely on their CGM data to make treatment
decisions, enabling more personalised and effective
self-management.”
When available, a new Dexcom patient can order and current users
can upgrade to the Dexcom G6 system, which includes a new G6
transmitter and sensors. The new touch screen receiver is optional
for international users and can be purchased separately. Users will
need a touch screen receiver or compatible smart device and the G6
app, along with the new G6 sensors and transmitter.
The CE Marking confirms that the G6 system meets the Essential
Requirements of the Medical Device Directive MDD 93/42/EEC as
amended by 2007/47/EC. The powerful and ground-breaking new system
is also the first CGM system to receive the US Food and Drug
Administration’s (FDA) De Novo classification. With this new
classification, the Dexcom G6 CGM system is indicated for use as
both a stand-alone CGM and for integration into automated insulin
dosing (AID) systems. For more information on Dexcom G6,
visit www.dexcom.com/en-GB.
About Dexcom G6
The Dexcom G6 is a stand-alone CGM system for MDI users, which
represent the vast majority of the type 1 population, and can also
be used by anyone on insulin pump therapy. With the G6, the sensor
is worn separately from an insulin pump and is inserted under the
skin to measure the level of glucose in the interstitial fluid
(fluid in the tissue). The sensor is disposable and should be
changed every 10 days.
About DexCom, Inc.
Founded in 1999, Dexcom, Inc. has corporate offices in San
Diego, California, EMEA headquarters in Edinburgh, Scotland and
users in 39 countries around the world. At Dexcom, we are
transforming diabetes care and management by providing superior
continuous glucose monitoring (CGM) technology to help people with
diabetes and healthcare professionals better manage diabetes. Since
our inception, we have focused on better outcomes for people with
diabetes, caregivers, and clinicians by delivering solutions that
are best in class-while empowering our community to take control of
diabetes. For more information on Dexcom CGM, visit
www.dexcom.com/global.
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