Dexcom G7 Gets FDA Approval: The Most Accurate Continuous Glucose Monitoring System Approved in the USA

Dexcom G7 Gets FDA Approval: The Most Accurate Continuous Glucose Monitoring System Approved in the USA

SAN DIEGO–()–DexCom, Inc. (NASDAQ:DXCM), the world chief in real-time steady glucose monitoring for folks with diabetes, introduced at present that the FDA has accepted the next-generation Dexcom G7 Steady Glucose Monitoring (CGM) System for every type of diabetes from two years previous. And older.

“There is a cause Dexcom has the best-selling real-time CGM in the marketplace,” stated Kevin Sayer, Dexcom president, chairman and CEO. “For over a decade, we have pioneered generational detection expertise that persistently delivers improved accuracy, reliability and an easier person expertise, giving folks extra management over their diabetes. After we began designing the G7, our aim was easy: to take advantage of highly effective, easy-to-use CGM obtainable for folks with Sort 1 or Sort 2 diabetes. The G7 absolutely delivers on this promise. And now that it has been accepted by the FDA, we sit up for making the G7 commercially obtainable within the coming months.”

New options with Dexcom G7:

  • 60% smaller, all-in-one, discreetwearable, simpler to make use of with fewer elements

  • 30-minute sensor warm-up, quickest of CGMs in the marketplace

  • 12-hour grace interval to interchange lifeless sensors for a smoother transition between classes

  • Redesigned and simplified cellular app with Dexcom Readability integration§,||

  • Enhanced alert settings for enhanced discretion

  • Smaller, redesigned non-compulsory receiver with a crisper, easier-to-read show

  • Indicated to be used on the again of the higher arm for ages 2 and up or on the higher hip for ages 2-17.

  • Smaller plastic elements and packaging leading to much less waste than the Dexcom G6 CGM Systemone

Dexcom G6 options included with Dexcom G7:

  • No fingerprints scanning or calibration

  • Actual-time glucose readings robotically despatched to a suitable imaging system each 5 minutes*

  • Integration with the world’s largest related CGM ecosystem (together with Apple Watch, Garmin and different digital well being apps)*

  • Distant monitoring that enables customers to share glucose knowledge with as much as 10 trackers#

  • Confirmed Dexcom accuracy and efficiency5

  • Solely CGM that may acknowledge doubtlessly harmful hypo-incidences earlier than they happen, providing predictive low alert

Dexcom is working intently with insulin pump companions to combine the Dexcom G7 into current and future automated insulin supply techniques as shortly as doable.

Confirmed efficiency with easy-to-use, customizable options

Most beneficial CGM model amongst sufferers with Dexcom G76 and healthcare suppliers7 now affords a small, all-in-one wearable, a totally redesigned cellular app and a extra highly effective and easier-to-use system that requires no fingertips or scanning required. The Dexcom G7 additionally affords a spread of customizable alerts that may warn of excessive or low glucose ranges, serving to customers spend extra time in vary.**,2 The system has a predictive low alert characteristic that gives 20 minutes of advance warning of doubtless harmful low glucose ranges, so customers can act shortly to keep away from a hypoglycemic occasion. This vital characteristic stays on the forefront of the Dexcom expertise, with greater than 52 million confirmed Pressing Coming Quickly alerts – greater than 11 million of them at midnight.one Customers may share data with family members and care groups wherever, anytime, because of industry-leading distant monitoring and reporting capabilities.# These options, amongst others, helped the Dexcom G7 be acknowledged as a winner of the CES 2023 innovation awards within the wearable expertise, digital well being class.

“Once I began utilizing the Dexcom CGM, the very first thing that caught my consideration was how simple it was to make use of,” stated Zac Harmon. Dexcom Warrior and blues musician. “It is small, non-intrusive, and has been the largest a part of my diabetes journey. It feels prefer it was made only for me so I can focus extra on the issues that basically matter in my life.

With essentially the most protection,4 extra customers pay much less for the #1 most well-liked CGM6.7

As diabetes turns into extra widespread, it’s extra vital than ever that every one folks with diabetes have entry to the very best care and expertise.

  • Dexcom is the primary coated and most compensated CGM in the marketplace4 one-third of commercially insured sufferers pay $0 out-of-pocket and the bulk pay lower than $40 a month††.8

  • Dexcom has sufferers paying $0 3 times greater than competing CGM techniques8 and at the moment over 97% of personal insurance coverage is reimbursed byone in addition to Medicare nationwide and Medicaid in 45 states.

  • The not too long ago proposed rule change by the Facilities for Medicare and Medicaid Companies to develop entry to CGM for extra folks with diabetes, together with these not on insulin remedy, has the potential to offer tens of millions of individuals in the USA entry to Dexcom CGM to allow them to do extra. successfully handle their diabetes

“Dexcom G7 is so easy and straightforward to make use of that it needs to be prescribed to anybody with Sort 1 and Sort 2 diabetes,” stated Thomas Grace, MD, a main care doctor in Findlay, Ohio. “The G7 shouldn’t be solely nice for folks with diabetes, it is nice for healthcare professionals as properly. Dexcom Readability’s integration into the cellular app gives easy accessibility to retrospective insights right into a affected person’s glycemic administration throughout in-person or telehealth appointments. With distinctive accuracy and ease of use. I’m assured that the G7 will change the sport for my sufferers.”

Dexcom plans to launch the Dexcom G7 within the US in early 2023. To facilitate quick entry to the G7 for as many customers as doable, the corporate can have accessible money fee choices whereas altering protection availability for the G7.

Go to dexcom.com and begin utilizing the Dexcom G6 at present to expertise the advantages of CGM now. To study extra concerning the Dexcom G7 and when it will likely be obtainable within the US, go to: Dexcom.com/G7.

DexCom, Inc. About

Dexcom, Inc. empowers folks to take management of diabetes via modern steady glucose monitoring (CGM) techniques. Headquartered in San Diego, California and with operations in Europe, Dexcom has emerged as a frontrunner in diabetes care expertise. Dexcom simplifies and improves diabetes administration worldwide by listening to the wants of customers, caregivers and suppliers. For extra data on Dexcom CGM, go to: www.dexcom.com.

Cautionary Assertion Relating to Ahead-Trying Statements

This press launch incorporates utterly non-historical forward-looking statements relating to the long run intentions, beliefs, expectations, and methods of Dexcom or its administration, together with statements relating to the timing of the business launch of the G7 in the USA. All forward-looking statements on this press launch and explanation why outcomes might differ are made based mostly on data at the moment held by Dexcom as of the date of this announcement, relate to future occasions, and are topic to varied dangers and uncertainties; future uncertainties relating to the business launch of the G7 in the USA, together with the dangers and availability of G7 protection, the timing and availability of money fee choices, and profitable and well timed collaboration with companions to facilitate the mixing of the G7 with insulin pumps and some other commercially obtainable system. automated insulin supply techniques and precise outcomes might differ materially from these projected in these forward-looking statements. The dangers and uncertainties that would trigger precise outcomes to vary materially from Dexcom’s present expectations are, as submitted to the Securities and Trade Fee on Oct. It’s defined in additional element within the Month-to-month Report. 2022. Besides as required by regulation, Dexcom undertakes no obligation to replace any such forward-looking statements after the date of this report or to adapt such forward-looking statements to precise outcomes.

* Suitable sensible units offered individually. To view an inventory of suitable sensible units, go to: dexcom.com/compatibility.

In comparison with the earlier era Dexcom CGM System.

The Dexcom G7 can full the warm-up in half-hour, whereas different CGM manufacturers require an hour or extra.

§ Healthcare suppliers can join Dexcom Readability at: clearness.dexcom.com/professional/registration.

|| An web connection is required for sufferers to ship glucose knowledge to Dexcom Readability through a suitable sensible system: dexcom.com/compatibility. Healthcare suppliers will solely be capable to view glucose knowledge if the affected person chooses to share it with them via Dexcom Readability.

In case your glucose alerts and readings from the Dexcom G7 don’t match signs or expectations, use a blood glucose meter to make diabetes therapy choices.

# Separate Dexcom Comply with app and web connection required. An web connection is required for knowledge sharing. Customers ought to all the time confirm readings on the Dexcom G7 app or receiver earlier than making therapy choices.

** Outcomes obtained with a earlier era Dexcom CGM System.

†† Refers back to the estimated out-of-pocket value of a Dexcom CGM sensor for eligible commercially insured sufferers if claims are adjudicated as a pharmacy profit, and consists of advantages and affords obtainable via current Dexcom packages, such because the coupon program. Precise value might fluctuate and is topic to particular person insurance coverage protection.

one Dexcom, knowledge on file, 2022.

2 Beck RW et al. JAMA. 2017;317(4):371-378.

3 Galli JB et al. J Diabetes Sci Technol. 2022:19322968221099879.

4 Managed Markets Insights & Expertise, LLC. MMIT Analytics, June 2022.

5 Dexcom G7 Person Guide.

6 dQ&A USA Q1 2021 Diabetes Hyperlinks Affected person Panel Report. 2021;69-72.

7 Seagrove HCP Survey, Q1 2021.

8 IQVIA, February 2022.

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