Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a leading insulin
delivery and diabetes technology company, today announced that its
next-generation automated insulin delivery (AID) algorithm,
Control-IQ+ technology (Control-IQ+), has been cleared by the
United States Food and Drug Administration (FDA) for use by people
with type 2 diabetes ages 18 and older. Control-IQ+, already
cleared for use by people with type 1 diabetes, builds on the
company’s proven Control-IQ algorithm and includes enhancements to
accommodate input of expanded weight and total daily insulin
ranges. Control-IQ+ is expected to be available for new and
existing customers in the United States in March 2025.
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The t:slim X2 insulin pump with
Control-IQ+ technology from Tandem Diabetes Care. (Photo: Business
Wire)
“We have seen firsthand, through numerous clinical and
real-world studies, how Control-IQ has improved health outcomes and
quality of life for our users with type 1 diabetes,” said John
Sheridan, president and chief executive officer. “It is a natural
evolution of our mission to bring the same AID technology that
helped to make Tandem the #1 recommended insulin pump brand by both
healthcare providers and people living with type 1 diabetes to
adults with type 2.”1,2
Control-IQ powers both Tandem insulin delivery systems – the
t:slim X2 and Tandem Mobi – to provide proven, best-in-class
outcomes. Results from major studies of Tandem’s technology in type
1 diabetes, including those published by the New England Journal of
Medicine (October 2019, August 2020, March 2023), show immediate
and sustained glycemic improvements, including more time in range
and improved sleep.3
This expanded label indication for type 2 diabetes is based on
results from a recently completed pivotal trial, representing the
first large-scale, randomized, controlled study of an automated
insulin delivery system, completed in more than 300 people with
type 2 diabetes. The trial compared use of a t:slim X2 pump with
Control-IQ+ technology to a control group who continued their
existing multiple daily injections regimens. Both groups used a
Dexcom G6 Continuous Glucose Monitoring (CGM) System for the
duration of the study. Full study results will be presented at the
18th International Conference on Advanced Technologies &
Treatments for Diabetes taking place in Amsterdam, the Netherlands
in March 2025.
“Type 2 diabetes affects millions of Americans and increases the
risk of serious health conditions, including heart disease, stroke,
kidney disease, and nerve damage, reinforcing the importance of
consistent management of blood sugar," said Jordan Pinsker, MD,
chief medical officer. “More than 2 million people in the U.S. rely
on intensive insulin therapy to manage their type 2 diabetes, and
we are proud to bring this life-changing technology to a group that
has historically had limited options for diabetes management.”
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
#TandemMobi and #TandemDiabetes. Follow Tandem Diabetes Care on
Facebook at www.facebook.com/TandemDiabetes. Follow Tandem Diabetes
Care on LinkedIn at
https://www.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 U.S. availability of
Control-IQ+, our ability to provide the software update for current
Tandem pump users and Tandem pumps pre-loaded with the Control-IQ+
software, the anticipated timing of the presentation of full study
results, and our mission to bring Control-IQ+ to persons with type
2 diabetes requiring intensive insulin. These forward-looking
statements are subject to numerous risks and uncertainties,
including the risks associated with our ability to develop, scale,
and maintain systems, personnel and infrastructure to support the
expansion of our products into the type 2 diabetes market segment
as well as other risks identified in our most recent Annual Report
on Form 10-K and Quarterly Reports on Form 10-Q, and other
documents we file 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.
Important Safety Information
RX ONLY. The t:slim X2 pump with interoperable technology (the
pump) and Control-IQ+ technology (Control-IQ+) are intended for
single patient use. The pump and Control-IQ+ are indicated for use
with NovoLog or Humalog U-100 insulin. t:slim
X2 insulin pump: The pump is intended for the subcutaneous
delivery of insulin, at set and variable rates, for the management
of diabetes mellitus in persons requiring insulin. The pump is able
to reliably and securely communicate with compatible, digitally
connected devices, including automated insulin dosing software, to
receive, execute, and confirm commands from these devices. The pump
is indicated for use in persons 2 years of age and greater.
Control-IQ+ technology: Control-IQ+
technology is intended for use with compatible integrated
continuous glucose monitors (iCGM, sold separately) and alternate
controller enabled (ACE) pumps to automatically increase, decrease,
and suspend delivery of basal insulin based on iCGM readings and
predicted glucose values. It can also deliver correction boluses
when the glucose value is predicted to exceed a predefined
threshold. Control-IQ+ technology is intended for the management of
Type 1 diabetes mellitus in persons 2 years of age and greater and
of Type 2 diabetes mellitus in persons 18 years of age and
greater.
WARNING: Control-IQ+ should not be used in anyone under
the age of 2 years old with Type 1 diabetes or under the age of 18
years old with Type 2 diabetes. It should also not be used in
patients who require less than a total daily insulin dose of 5
units of insulin per day or who weigh less than 20 pounds (9
kilograms), as those are the required minimum values needed in
order for Control-IQ+ to operate safely.
Users of the pump and Control-IQ+ must: use the insulin pump,
iCGM, and all other system components in accordance with their
respective instructions for use. Failure to follow these
instructions for use could result in an over delivery or under
delivery of insulin. This can cause hypoglycemia (low BG) or
hyperglycemia (high BG) events. Visit tandemdiabetes.com/safetyinfo
for additional important safety information.
© 2025 Tandem Diabetes Care, Inc. All rights reserved. Tandem
Diabetes Care, the Tandem logo, Control-IQ, Control-IQ+, t:slim X2,
and Tandem Mobi are either registered trademarks or trademarks of
Tandem Diabetes Care, Inc. in the United States and/or other
countries. Dexcom and Dexcom G6 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.
____________________
1
Seagrove Partners HCP
Perspectives (Devices), September 2024 Insulin Delivery section
N=269.
2
dQ&A US Diabetes Connections
Patient Panel Report, Q1 2024 (Jan.-March 2024)
3
Breton MD, Kovatchev BP. One-year
real-world use of the Control-IQ advanced hybrid closed-loop
technology. Diabetes Technol Ther. 2021;23(9):601-608. doi:
10.1089/dia.2021.0097
View source
version on businesswire.com: https://www.businesswire.com/news/home/20250225281388/en/
Media Contact: 858-366-6900 Media@tandemdiabetes.com
Investor Contact: 858-366-6900 IR@tandemdiabetes.com
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