Tandem Diabetes Care Automated Insulin Delivery Systems Receive CE Mark for Type 2 Diabetes and Type 1 Diabetes During Pregnancy

SAN DIEGO--(BUSINESS WIRE)--$TNDM #TandemMobi--Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a leading insulin delivery and diabetes technology company, today announced receipt of CE mark for expanded indications of its automated insulin delivery (AID) systems in Europe. The t:slim X2 and Tandem Mobi insulin delivery systems running Control-IQ+ AID technology are now approved for use by people with type 1 diabetes during pregnancy and adults with type 2 diabetes.

“These expanded indications underscore the strength of our portfolio and our commitment to bringing innovative diabetes technology to more people worldwide,” said John Sheridan, president and chief executive officer. “By expanding access to our AID technology, we’re broadening our impact and advancing our mission to improve lives across the diabetes community.”

Pregnancy in Type 1 Diabetes

This expanded label indication for use in type 1 diabetes during pregnancy is based on results from the CIRCUIT trial published in Journal of the American Medical Association (JAMA) in October 2025.1 Participants in this multi-center, randomized controlled trial were assigned to use a t:slim X2 insulin pump with Control-IQ technology or to continue their multiple daily insulin injections or insulin pump with continuous glucose monitoring. The Control-IQ group experienced 12.6% more time in the pregnancy glucose target range 3.5-7.8 mmol/L (63-140 mg/dL), approximately 3 hours more per day, compared to those using their standard therapy, from 16 weeks gestation to the end of pregnancy.

Data from the CIRCUIT Trial will be presented this weekend during a product theater at the 2026 Scientific Sessions of the American Diabetes Association in New Orleans, Louisiana. The presentation takes place on Saturday, June 6 from 10:15 am to 11:00 am Central Time in Product Theater #1.

Adults with Type 2 Diabetes

“The benefits of Control-IQ+ technology were evident across an incredibly diverse population of people with type 2 diabetes, regardless of pre-study glycemic control or experience with diabetes technology,” said Jordan Pinsker, MD, chief medical officer.

This expanded label indication for adults with type 2 diabetes is based on strong clinical evidence from the first large-scale, randomized, controlled study of an automated insulin delivery system in type 2 diabetes (the 2IQP trial), completed in more than 300 people with type 2 diabetes, and published in the New England Journal of Medicine in March 2025.2 The trial compared use of a t:slim X2 pump with Control-IQ+ technology to a control group who continued their existing insulin regimen. Both groups used a Dexcom G6 Continuous Glucose Monitoring (CGM) System for the duration of the study. In the pivotal study, people using Control-IQ+ achieved a 0.9% reduction in A1C, compared with 0.3% in the control group, with those entering the study at A1C levels of 9% or higher seeing a 2.3% reduction. The technology was shown to be safe, with low rates of hypoglycemia, no new safety signals identified, and no diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome events reported.

About Tandem Diabetes Care Automated Insulin Delivery Systems

Tandem Diabetes Care manufactures the t:slim X2, the all-in-one insulin delivery system for convenient diabetes management, and the Tandem Mobi, the world's smallest durable AID system. Both systems are powered by Control-IQ+ AID technology to provide proven, best-in-class outcomes. Results from major studies in type 1 and type 2 diabetes, including those published by the New England Journal of Medicine (October 2019, August 2020, March 2023, and March 2025), show immediate and sustained glycemic improvements, including more time in range and improved sleep.

The t:slim X2 insulin pump is currently available in several European countries. The Tandem Mobi system is expected to begin launching in select countries in the second half of 2026. For more information, visit tandemdiabetes.com.

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.

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1 Donovan LE, Lemieux P, Dunlop AD, et al. Closed-Loop Insulin Delivery in Type 1 Diabetes in Pregnancy: The CIRCUIT Randomized Clinical Trial. JAMA. 2025;334(24):2176-2185. doi:10.1001/jama.2025.19578 2 Kudva YC, Raghinaru D, Lum JW, et al. A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes. N Engl J Med. 2025; 393(6):617-618. doi: 10.1056/NEJMc2507995.

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