Tandem Diabetes Care begins global commercial rollout of t:slim X2 pump integration with the FreeStyle Libre 3 Plus CGM sensor, expanding choice and personalization for people living with diabetes worldwide

Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a global insulin delivery and diabetes technology company, announced that the t:slim X2 insulin pump, featuring Control-IQ+ automated insulin delivery (AID) technology, is now available with Abbott’s FreeStyle Libre 3 Plus continuous glucose monitoring (CGM) sensor integration in the United States.* This is the first step in a global commercial rollout that expands choice and personalization for people living with diabetes worldwide. In the U.S., the updated software for the FreeStyle Libre 3 Plus sensor integration is preloaded on all new t:slim X2 pump shipments, and is also available to all eligible t:slim X2 pump users through a software update.^† The Company plans to launch early-access programs for the integrated technologies internationally before the end of the year, with scaling commercial availability to follow in 2026.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251029416700/en/

The t:slim X2™ Insulin Pump with Abbott’s FreeStyle Libre® 3 Plus Sensor is now available in the United States, beginning global commercial rollout.

“With this integration, we expand the benefits of greater control to more people living with diabetes worldwide with our AID system that is easy to start, use, and personalize,” said John Sheridan, president and chief executive officer. “It combines Control-IQ+, our most advanced algorithm ever, together with the benefits of Abbott’s latest CGM sensor on our tested and trusted t:slim X2 insulin pump.”

The FreeStyle Libre 3 Plus sensor is the world’s smallest CGM available today.¹ It transmits automatic glucose readings every minute directly to the pump and offers an extended 15-day wear time. Control-IQ+ technology is Tandem's newest advanced hybrid closed-loop algorithm, which adjusts insulin every five minutes based on predicted glucose values. It is also the only system featuring AutoBolus,^‡ which automatically calculates and delivers a correction bolus, helping reduce the impact of missed meal boluses and easing the day-to-day burden of diabetes management.

Tandem will email all eligible t:slim X2 users in the United States with instructions on how to add the new compatibility feature free of charge via remote software update.^†

To learn more about this integration in the United States visit: www.tandemdiabetes.com/products/cgm-partners/freestyle-libre

Early access recruitment and communication about commercial availability in additional countries will be addressed in each region.

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 @TandemDiabetesCare on TikTok and @TandemDiabetes on Facebook, Instagram, LinkedIn, and X.

* CGM sold separately

† Software updates may not be offered everywhere and would be subject to applicable regulatory approvals. Charges may apply.

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

Reference

1. Among patient-applied sensors. Data on file. Abbott Diabetes Care, Inc.

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, Tandem logos, 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. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251029416700/en/