Tandem t:slim X2 Insulin Pump Now Compatible With Lyumjev Ultra-Rapid Acting Insulin in the United States

SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced that its t:slim X2™ insulin pump with Control-IQ+ automated insulin delivery (AID) technology is now cleared for use with Eli Lilly and Company’s Lyumjev® (insulin lispro-aabc injection) ultra-rapid acting insulin in the United States (U.S.).

“This latest milestone reinforces our commitment to facilitating choice and access for people who rely on insulin therapy,” said Jordan Pinsker, MD, Chief Medical Officer at Tandem Diabetes Care. “This clearance allows people with type 1 diabetes ages 2 and above and all adults with type 2 diabetes to use Lyumjev with the t:slim X2 insulin pump, providing more flexibility for how people choose to manage their diabetes.”

Lyumjev clearance for use with the t:slim X2 insulin pump with Control-IQ+ technology was based on data from a 13-week, multicenter study of 179 individuals that showed high satisfaction and quality of life benefits.ⁱ Lyumjev was authorized for general use in insulin pumps in the U.S. in 2021, but pump manufacturers are required to perform extensive testing to verify compatibility with individual insulin pumps and automated insulin delivery systems. Tandem and Lilly collaborated to support the clinical trial showing benefits of using Lyumjev with Control-IQ+ technology. The companies continue to work to secure Lyumjev compatibility for the Tandem Mobi pump.

Please see Lyumjev Full Prescribing Information including Patient Prescribing Information. Lyumjev is available through the Lilly Insulin Value Program, which allows anyone with commercial insurance or no insurance to fill a monthly prescription for $35.ⁱⁱ

The t:slim X2 pump is now cleared in the U.S. for use with Humalog, Novolog, and Lyumjev U-100 insulins.

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.

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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, Tandem’s ability to expand compatibility of its technology with Lyumjev. These statements are subject to numerous risks and uncertainties, including Tandem’s ability to secure Lyumjev compatibility for the t:slim X2 pump in other regions and/or the timing thereof, the ability to secure Lyumjev compatibility for the Tandem Mobi pump in any region and/or the timing thereof, as well as other risks and uncertainties identified in the Company’s most recent Annual Report on Form 10-K and its other filings 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, Humalog, or Lyumjev 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+, Tandem Mobi and t:slim X2 are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All third-party marks are the property of their respective owners.

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ⁱ Levy CJ, Bailey R, Laffel LM, et al. Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes. Diabetes Technol Ther. 2024 Sep;26(9):652-660.

ⁱⁱ Terms and conditions apply. Automatically applied at the majority of retail pharmacies for those with commercial insurance. Government restrictions exclude people enrolled in federal government insurance programs from Lilly's $35 solutions. But federal law provides that Medicare Part D beneficiaries also pay no more than $35 per month for insulin.

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Source: Tandem Diabetes Care, Inc.