Tandem Diabetes Care Announces Publication Showing Adults With Type 2 Diabetes Benefit from Automated Insulin Delivery Regardless of C-Peptide Levels

This sub-analysis is the first study to evaluate AID outcomes for people with type 2 diabetes using the Center for Medicare and Medicaid Services (CMS) criteria for insulin pump coverage.

Tandem Diabetes Care® (NASDAQ:TNDM), a global insulin delivery and diabetes technology company, today announced the publication of a study, "Adults with Type 2 Diabetes Benefit from Automated Insulin Delivery Irrespective of C-peptide Level," in the American Diabetes Association's Diabetes Care. The study, a sub-analysis from the 2IQP randomized, controlled trial, found that the Control-IQ+ automated insulin delivery (AID) system was beneficial for adults with insulin-treated type 2 diabetes, regardless of their C-peptide levels.

Of the 319 participants in the 2IQP trial, 254 were included in this specific analysis. Researchers categorized participants, all of whom had type 2 diabetes and were using a t:slim X2 insulin pump with Control-IQ+ AID technology, into a 'high C-peptide' group (N=195) and a 'low C-peptide' group (N=59) based on CMS criteria.

Participants in the AID group experienced a mean HbA1c decrease of 0.8% from baseline, which was significantly greater than the control group. This improvement was the same between the high and low C-peptide groups, demonstrating that the benefit of AID is present regardless of C-peptide levels. Unfortunately, CMS criteria currently require a low C-peptide level for insulin pump coverage, which excludes many people with type 2 diabetes from obtaining an AID system, even if they had already been benefiting from the technology prior to moving to Medicare.

"The 2IQP trial demonstrated that AID provides benefits to adults with insulin-treated type 2 diabetes across a range of demographics and treatment regimens, comparable to the outcomes seen in type 1 diabetes," said Irl B. Hirsch, MD, from the University of Washington School of Medicine and lead author of the manuscript. "These new analyses show that AID is effective regardless of C-peptide levels, indicating that a low C-peptide threshold should not be required for therapy."

Reference:

I Hirsch, Y Kudva, D Ahn, et al. Adults with Type 2 Diabetes Benefit from Automated Insulin Delivery Irrespective of C-peptide Level. Diabetes Care 2025; doi: 10.2337/dc25-1125. https://doi.org/10.2337/dc25-1125

Full results from the 2IQP trial were published in the New England Journal of Medicine in March 2025.

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.

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

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 potential of Control-IQ+ AID systems to improve the outcomes of people living with type 2 diabetes who use insulin. These forward-looking statements are subject to numerous risks and uncertainties, including risks, for example, that the real-world clinical benefits from use of Control-IQ+ AID systems may not match the results reported in the study as well as other risks identified in our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other documents that 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 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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