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

About this update from Tandem Diabetes Care, Inc.

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 Eng...

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