– Only Automated Insulin Delivery System in
Canada to Feature Both Dexcom G7 and G6 CGM Technology Now
Authorized for Sale by Health Canada –
Tandem Diabetes Care, Inc. (Nasdaq: TNDM) and Dexcom, Inc.
(Nasdaq: DXCM) today announced the updated t:slim X2™ insulin pump
software is compatible with both Dexcom G7 and Dexcom G6 Continuous
Glucose Monitoring (CGM) Systems and is authorized for sale by
Health Canada. This integration allows users of the t:slim X2
insulin pump with Control-IQ technology, the #1 rated automated
insulin delivery (AID) system in Canada,* to have even more choice
in how they manage their diabetes.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240725748503/en/
t:slim X2 Insulin Pump with Dexcom G7 CGM
Compatibility is Authorized for Sale by Health Canada (Photo:
Business Wire)
Commercial availability is expected to begin this fall. Tandem
will email instructions to all users in Canada with an in-warranty
t:slim X2 pump to offer the option to choose between Dexcom G7 and
Dexcom G6 via a free remote software update. New customers will
receive t:slim X2 pumps pre-loaded with the updated software.
“This integration marks the first time an AID system in Canada
is compatible with both Dexcom G7 and Dexcom G6 CGMs, demonstrating
our commitment to continued leadership in advancing AID systems and
offering choice,” said Mark Novara, executive vice president and
chief commercial officer of Tandem Diabetes Care. “We are proud to
celebrate more than 10 years of partnership with Dexcom through
this milestone that allows users in Canada to benefit from our #1
recommended insulin pump brand,† now with Dexcom's most advanced
CGM technology.”
“Studies have shown that an AID system powered by Dexcom CGM
allows people with diabetes to experience more time in range and
can help users reduce nighttime lows,”1 said André Côté, executive
vice president and general manager of Dexcom Canada. “Sensor
accuracy is key to automated insulin delivery, and we are thrilled
that Canadians using the t:slim X2 insulin pump with Control-IQ
technology will soon be able to benefit from integration with
Dexcom G7, our smallest and most accurate CGM 2‡. This milestone
underscores the shared commitment between Dexcom and Tandem to
provide cutting-edge technology that empowers individuals with
diabetes to live better and feel better every day.”
Dexcom G7 users benefit from:
- Greater discretion with Dexcom G7’s low-profile all-in-one
sensor and transmitter, which is 60% smaller3 than Dexcom G6;
- More time in closed loop with a 30-minute sensor warmup
time4;
- A 12-hour grace period4 to replace finished sensors for a more
seamless transition between sessions and flexibility for when to
change sensors;
- Increased connectivity that Dexcom G7 offers with leading
digital health apps.
t:slim X2 insulin pump with Control-IQ technology
features:
- #1 Rated AID System in Canada* with Control-IQ
Technology – Uses data from the Dexcom CGM to predict glucose
levels 30 minutes ahead and automatically adjust insulin, if
needed, to help prevent highs and lows.
- Activity Settings: Includes customizable Personal
Profiles and optional settings for Sleep Activity or Exercise
Activity that adjust the range of treatment values.
- Infusion Set Options: A variety of on-body
infusion sets allow users to temporarily disconnect from their pump
for convenience and provide the flexibility of more than 30
mix-and-match infusion set and tubing length combinations.
The t:slim X2 pump with Dexcom G7 integration launched in the
U.S. in December 2023 and additional countries in early 2024.
To check coverage and start the process of getting a Tandem
insulin pump, please visit tandemdiabetes.ca.
To learn more about Dexcom G6 or Dexcom G7, please visit
dexcom.com or ask your healthcare provider.
* dQ&A Canada Patient Panel H2 2023 † dQ&A Canada
Patient Panel H2 2023 ‡ When compared with CGM systems commercially
available in Canada as of July 2024.
1 Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month
randomized, multicenter trial of closed-loop control in type 1
diabetes. N Engl J Med. 2019;381(18):1701-1717. doi:
10.1056/NEJMoa1907863. 2 Dexcom, Data on File, 2023. 3 Garg SK,
Kipnes M, Castorino K, et al. Accuracy and Safety of Dexcom G7
Continuous Glucose Monitoring in Adults with Diabetes. Diabetes
Techol Ther. 2022;24(6):373-380. doi: 10.1089/dia.2022.0011. 4
Dexcom G7 User Guide
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, a global insulin delivery and diabetes
technology company, manufactures and sells advanced automated
insulin delivery systems that reduce the burden of diabetes
management, while creating new possibilities for patients, their
loved ones, and healthcare providers. The Company’s pump portfolio
features the Tandem Mobi system and the t:slim X2 insulin pump,
both of which feature Control-IQ advanced hybrid closed-loop
technology. Tandem Diabetes Care is based in San Diego, California.
For more information, visit tandemdiabetes.com.
Follow Tandem Diabetes Care on X @tandemdiabetes; use #tslimX2
and #TandemDiabetes. Follow Tandem Diabetes Care on Facebook at
facebook.com/TandemDiabetesCanada. Follow Tandem Diabetes Care on
LinkedIn at linkedin.com/company/tandemdiabetes.
Forward-looking Statements
This press release contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These forward-looking statements relate to, among other
things, the anticipated timing for the Canadian availability of the
t:slim X2 pump with Dexcom G7 integration as well as our ability to
provide the software update for current t:slim X2 pump users and
the t:slim X2 pumps pre-loaded with Dexcom G7 integration software.
These statements are subject to numerous risks and uncertainties,
including our ability to start commercial scale manufacturing of
the t:slim X2 pumps pre-loaded with Dexcom G7 integration software
for the Canadian market, our ability to operate and maintain a
system to facilitate online training for existing t:slim X2 pump
customers upgrading their existing devices, and the risk that we
may encounter other challenges that may delay the availability of
t:slim X2 pumps pre-loaded with Dexcom G7 integration software.
These and other risks are identified and described in greater
detail under the “Risk Factors” heading of our most recent Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q, and other
documents filed with the Securities and Exchange Commission.
Readers are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
release. Actual results could differ materially from those
anticipated or projected in the forward-looking statements. Tandem
undertakes no obligation to update or review any forward-looking
statement in this press release because of new information, future
events, or other factors.
Responsible use of Control-IQ technology
Control-IQ technology does not prevent all highs and lows. Users
must still bolus for meals and actively manage their diabetes.
Visit tandemdiabetes.com/safetyinfo for additional important safety
information.
This product may not be right for you. Always read and follow
the label.
Important Safety Information: The t:slim X2 insulin pump
with Control-IQ technology (the System) consists of the t:slim X2
insulin pump, which contains Control-IQ technology, and a
compatible continuous glucose monitor (CGM, sold separately). The
t:slim X2 insulin pump is intended for the subcutaneous delivery of
insulin, at set and variable rates, for the management of diabetes
mellitus in people requiring insulin. The t:slim X2 insulin pump
can be used solely for continuous insulin delivery and as part of
the System. When used with a compatible CGM, the System can be used
to automatically increase, decrease, and suspend delivery of basal
insulin based on CGM sensor readings and predicted glucose values.
The System can also deliver correction boluses when the glucose
value is predicted to exceed a predefined threshold. The pump and
the System are indicated for use in individuals 6 years of age and
greater. The pump and the System are intended for single user use.
The pump and the System are indicated for use with NovoRapid,
Admelog, Trurapi, or Humalog U-100 insulin. The System is intended
for the management of Type 1 diabetes.
WARNING: Control-IQ technology should not be used by anyone
under the age of 6 years old. It should also not be used in users
who require less than 10 units of insulin per day or who weigh less
than 25 kilograms.
The System is not indicated for use in pregnant women, people on
dialysis, or critically ill users. Do not use the System if using
hydroxyurea.
Users of the pump and the System must: be willing and able to
use the insulin pump, CGM, and all other system components in
accordance with their respective instructions for use; test blood
glucose levels as recommended by their healthcare provider;
demonstrate adequate carb-counting skills; maintain sufficient
diabetes self-care skills; see healthcare provider(s) regularly;
and have adequate vision and/or hearing to recognize all functions
of the pump, including alerts, alarms, and reminders. The t:slim X2
pump must be removed before MRI, CT, or diathermy treatment. Visit
tandemdiabetes.com/safetyinfo for additional important safety
information.
© 2024 Tandem Diabetes Care, Inc. All rights reserved. Tandem
Diabetes Care, the Tandem logo, Control-IQ, and t:slim X2 are
either registered trademarks or trademarks of Tandem Diabetes Care,
Inc. in the United States and/or other countries. Dexcom, Dexcom
G6, Dexcom G7, and any related logos and design marks are either
registered trademarks or trademarks of Dexcom, Inc. in the United
States and/or other countries. All other third-party marks are the
property of their respective owners.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240725748503/en/
Tandem Diabetes Care Media Contact: 858-366-6900
media@tandemdiabetes.com
Tandem Diabetes Care Investor Contact: 858-366-6900
IR@tandemdiabetes.com
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