- Dexcom G7 is now cleared in the U.S. for people with all Types
of diabetes ages two years and older, giving more people than ever
access to a powerfully simple diabetes management solution
- With an overall MARD of 8.2%, Dexcom G7 is the most accurate
CGM cleared by the FDA,1 building on the trusted performance of
Dexcom CGM, which is clinically proven to lower A1C, reduce hyper-
and hypoglycemia and increase time in range2,3
- Cleared as an integrated continuous glucose monitoring (iCGM)
system, Dexcom G7 will be part of the most connected CGM ecosystem
in the world,1 with real-time connectivity that can drive
integrated insulin delivery systems, connect with wearables like
the Apple Watch and integrate with popular digital health
apps*
- As the number one covered CGM on the market,4 most Dexcom users
pay less than those using other CGM systems1
DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time
continuous glucose monitoring for people with diabetes, announced
today the FDA has cleared the next-generation Dexcom G7 Continuous
Glucose Monitoring (CGM) System for people with all Types of
diabetes ages two years and older.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20221208005302/en/
Dexcom G7 now offers a more powerful and
easier to use system with a small, all-in-one wearable with no
fingersticks or scanning required. (Photo: Business Wire)
“There’s a reason Dexcom has the best-selling real-time CGM on
the market,” said Kevin Sayer, chairman, president and CEO of
Dexcom. “For more than a decade, we’ve pioneered generation after
generation of sensing technology that consistently delivers
improved accuracy, reliability and a simpler user experience,
giving people greater control of their diabetes. When we set out to
design G7, our goal was simple: to make the most powerful,
easy-to-use CGM available for people with diabetes, whether they
have Type 1 or Type 2. G7 delivers squarely on that promise. And
now that it has been cleared by the FDA, we look forward to making
G7 commercially available in the coming months.”
New features with Dexcom G7:
- 60% smaller, all-in-one, discreet† wearable, easier to use with
fewer components
- 30-minute sensor warmup, fastest of any CGM on the market‡
- 12-hour grace period to replace finished sensors for a more
seamless transition between sessions
- Redesigned and simplified mobile app with Dexcom Clarity
integration§,||
- Improved alert settings for enhanced discretion
- Redesigned optional receiver that is smaller, with a more
vibrant, easier to read display
- Indicated for wear on the back of the upper arm for ages 2
years and older or the upper buttocks for ages 2-17 years old
- Smaller plastic components and packaging, resulting in less
waste than the Dexcom G6 CGM System1
Dexcom G6 features included with Dexcom
G7:
- No fingersticks, scanning or calibration
- Real-time glucose readings sent automatically every 5 minutes
to a compatible display device*
- Integration with the world’s largest connected CGM ecosystem
(including Apple Watch, Garmin and other digital health apps)*
- Remote monitoring, enabling users to share glucose data with up
to 10 followers#
- Proven Dexcom accuracy and performance5
- Only CGM to offer a predictive low alert that can recognize
potentially dangerous hypo-incidences before they occur
Dexcom is working closely with its insulin pump partners to
integrate Dexcom G7 into current and future automated insulin
delivery systems as quickly as possible.
Proven performance with easy-to-use, customizable
features
With Dexcom G7, the most recommended CGM brand among patients6
and healthcare providers7 now offers a more powerful and easier to
use system with a small, all-in-one wearable, completely redesigned
mobile app and no fingersticks or scanning required. Dexcom G7 also
offers a suite of customizable alerts that can warn of high or low
glucose levels and help users spend more time in range.**,2 The
system features a predictive low alert that provides a 20-minute
advance warning of potentially dangerous low glucose levels so
users can act quickly to avoid a hypoglycemic event. This critical
feature continues to be at the forefront of the Dexcom experience,
with more than 52 million Urgent Low Soon alerts acknowledged –
more than 11 million of those in the middle of the night.1 Users
can also share information with loved ones and care teams anywhere,
anytime through industry-leading remote monitoring and reporting
capabilities.# These features, among others, helped Dexcom G7 earn
recognition as a CES 2023 innovation awards honoree in the wearable
technology, digital health category.
“The first thing that stood out to me when I started using the
Dexcom CGM was how easy it was to use,” said Zac Harmon, a Dexcom
Warrior and blues musician. “It’s small, non-intrusive and has been
the biggest part of my diabetes journey. It feels like it was made
just for me, so I can focus more on what’s really important in my
life.”
With the most coverage,4 more users pay less for the #1
preferred CGM6,7
As diabetes becomes increasingly prevalent, it’s more important
than ever for all people with diabetes to have access to the best
care and technology.
- Dexcom is the number one covered and most reimbursed CGM on the
market4 with a third of patients with commercial coverage paying $0
out-of-pocket and the majority paying less than $40 per
month††,8
- Dexcom has three times more patients paying $0 than competing
CGM systems8 and is currently reimbursed by more than 97% of
private insurance1 as well as Medicare nationwide and Medicaid in
45 states
- The recent proposed rule change from the Centers for Medicare
and Medicaid Services to expand access to CGM for more people with
diabetes, including those not on insulin therapy, has the potential
to give millions more people in the US access to Dexcom CGM so they
can more effectively manage their diabetes
“Dexcom G7 is so simple and easy to use that it should be
prescribed to every person with Type 1 and Type 2 diabetes,” said
Thomas Grace, MD, a primary care physician in Findlay, Ohio. “G7
isn’t just great for people with diabetes, it’s great for
healthcare professionals as well. The integration of Dexcom Clarity
into the mobile app provides easy access to retrospective insights
about a patient’s glycemic management during in person or
telehealth appointments. With its exceptional accuracy and ease of
use, I’m confident G7 will be a game changer for my patients.”
Dexcom expects to initiate a US launch of Dexcom G7 in early
2023. To facilitate immediate access to G7 for as many users as
possible, the company will have accessible cash pay options in
place as the company transitions coverage availability for G7.
Visit Dexcom.com and get started with Dexcom G6
today to experience the benefits of CGM now. To learn more about
Dexcom G7 and for additional information about when it will be
available in the US, visit Dexcom.com/G7.
About DexCom, Inc.
Dexcom, Inc. empowers people to take control of diabetes through
innovative continuous glucose monitoring (CGM) systems.
Headquartered in San Diego, California, and with operations across
Europe, Dexcom has emerged as a leader of diabetes care technology.
By listening to the needs of users, caregivers and providers,
Dexcom simplifies and improves diabetes management around the
world. For more information about 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 statements with respect to timing of the commercial
launch of G7 in the United States. All forward-looking statements
and reasons why results might differ included in this press release
are made as of the date of this release, based on information
currently available to Dexcom, deal with future events, are subject
to various risks and uncertainties, including risks and
uncertainties relating to the commercial launch of G7 in the United
States, including the availability of coverage for G7, the timing
and accessibility of cash pay options, and successful and timely
collaboration with partners to facilitate the integration of G7
with commercially available insulin pumps and any future automated
insulin delivery systems, and actual results could differ
materially from those anticipated in those forward-looking
statements. The risks and uncertainties that may cause actual
results to differ materially from Dexcom’s current expectations are
more fully described in Dexcom’s Quarterly Report on Form 10-Q for
the period ended September 30, 2022, as filed with the Securities
and Exchange Commission on October 28, 2022. Except as required by
law, Dexcom assumes no obligation to update any such
forward-looking statement after the date of this report or to
conform these forward-looking statements to actual results.
* Compatible smart devices sold separately. To view a list of
compatible smart devices, visit dexcom.com/compatibility. †
Compared to a prior generation Dexcom CGM System. ‡ Dexcom G7 can
complete warmup within 30 minutes, whereas other CGM brands require
up to an hour or longer. § Healthcare providers can register for
Dexcom Clarity at clarity.dexcom.com/professional/registration. ||
An internet connection is required for patients to send their
glucose data to Dexcom Clarity via a compatible smart device:
dexcom.com/compatibility. Healthcare providers will only be able to
view a patient’s glucose data if the patient elects to share it
with them through Dexcom Clarity. If your glucose alerts and
readings from Dexcom G7 do not match symptoms or expectations, use
a blood glucose meter to make diabetes treatment decisions. #
Separate Dexcom Follow app and internet connection required.
Internet connectivity required for data sharing. Users should
always confirm readings on the Dexcom G7 app or receiver before
making treatment decisions. ** Results obtained with a prior
generation Dexcom CGM System. †† Refers to estimated out-of-pocket
cost for eligible commercially insured patients from the Dexcom CGM
sensor when claims are adjudicated as a pharmacy benefit, and
includes benefits and offerings through available Dexcom programs,
such as the voucher program. Actual cost may vary and is subject to
individual insurance coverage.
1 Dexcom, data on file, 2022. 2 Beck RW, et al. JAMA.
2017;317(4):371-378. 3 Welsh JB, et al. J Diabetes Sci Technol.
2022:19322968221099879. 4 Managed Markets Insights &
Technology, LLC. MMIT Analytics, June 2022. 5 Dexcom G7 User Guide.
6 dQ&A US Q1 2021 Diabetes Connections Patient Panel Report.
2021;69-72. 7 Seagrove HCP Survey, Q1 2021. 8 IQVIA, February
2022.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221208005302/en/
Media Contact James McIntosh
619-884-2118 james.mcintosh@dexcom.com
Investor Contact Sean
Christensen 858-203-6657 sean.christensen@dexcom.com
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