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Tandem Diabetes Care Announces t:slim X2™ Insulin Pump Compatibility with Abbott’s FreeStyle Libre® 3 Plus Sensor in the United States

via Business Wire

Tandem continues to build its technology ecosystem to expand choice and personalization for people living with diabetes

Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company today announced the Tandem t:slim X2™ insulin pump with Control-IQ+ automated insulin delivery (AID) technology now works with Abbott’s FreeStyle Libre® 3 Plus continuous glucose monitoring (CGM) sensor. The Company has initiated an early access program in the United States (U.S.), and intends to scale availability in the second half of 2025.

“Diabetes management is not one-size-fits-all and it is critical for people living with diabetes to be able to personalize their AID systems to fit their unique healthcare and lifestyle needs,” said Dr. Jordan Pinsker, chief medical officer of Tandem Diabetes Care. “The American Diabetes Association recommends AID systems as the preferred insulin delivery method in people with type 1 and other types of insulin-deficient diabetes, and this integration with Abbott’s latest generation sensor allows even more CGM users to access the life-changing benefits of our Control-IQ+ technology.”

The FreeStyle Libre 3 Plus sensor has an extended 15-day wear time, transmitting automatic glucose readings every minute directly to the pump. This data is also available to view on the Tandem t:slim mobile app, providing users with multiple, convenient ways to access their current glucose trend.

The t:slim X2 insulin pump is powered by Control-IQ+ technology, the latest generation of Tandem's advanced hybrid closed-loop algorithm, which adjusts insulin every 5 minutes based on predicted glucose values. It’s the only system with the unique AutoBolus™ feature that calculates and delivers a correction bolus to help with missed meal boluses.* Control-IQ+ is easy to start, use, and personalize, and this latest integration works with the FreeStyle Libre 3 Plus sensor and extends its benefits to even more people with diabetes.

“This is an exciting first step in our strategy to connect Tandem's portfolio of insulin pumps to Abbott’s FreeStyle Libre 3 Plus sensors worldwide,” said John Sheridan, president and chief executive officer of Tandem Diabetes Care. “We look forward to expanding access to our t:slim X2 users outside of the U.S. beginning later this year.”

When available, Tandem will email eligible users in the U.S. with more information.†

About Tandem Diabetes Care

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.

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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, our ability to provide the software update for current t:slim X2 pump users and the t:slim X2 pumps pre-loaded with Freestyle Libre 3 Plus sensor integration software. These statements are subject to numerous risks and uncertainties, including our ability to sustain commercial scale manufacturing of the t:slim X2 pumps pre-loaded with Freestyle Libre 3 Plus sensor integration software, 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 the software update for current t:slim X2 pump users or the t:slim X2 pumps pre-loaded with Freestyle Libre 3 Plus sensor 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.

Important Safety Information – FreeStyle Libre Systems

Product for prescription only; for Important Safety Information, please visit FreeStyleLibre.us.

Important Safety Information – Tandem Diabetes Care

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 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+, t:slim X2, t:slim, and Tandem Mobi are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. The sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott and used with permission. All other third-party marks are the property of their respective owners.

* If glucose values are predicted to be above 180 mg/dL (or 10.0 mmol/L), Control-IQ technology calculates a correction bolus using the Personal Profile settings and a target of 110 mg/dL (or 6.1 mmol/L) and delivers 60% of that value.

† Future updates for all or some Tandem products may not be developed and may not be offered everywhere and would be subject to applicable regulatory approvals. Software updates are only available to customers who are in warranty at the time they update their pump. Additional training may be required to access certain software updates. Charges may apply. Tandem may discontinue select software and features over time at its discretion.

“This is an exciting first step in our strategy to connect Tandem's portfolio of insulin pumps to Abbott’s FreeStyle Libre 3 Plus sensors worldwide.” - John Sheridan, president and chief executive officer of Tandem Diabetes Care.

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