Tandem Diabetes Care has announced that its t:slim X2 and Tandem Mobi automated insulin delivery (AID) systems, powered by Control-IQ+ technology, have received expanded CE mark approvals in Europe. The updated indications allow use of the systems by adults with type 2 diabetes and by people managing type 1 diabetes during pregnancy.
The regulatory milestone extends access to automated insulin delivery technology to two patient populations that often require intensive glucose management. According to Tandem, the expanded approvals reflect growing clinical evidence supporting the use of advanced insulin delivery systems across a broader spectrum of diabetes care.
“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.”
The pregnancy indication is supported by findings from the CIRCUIT trial, a multicenter randomized controlled study published in the Journal of the American Medical Association in October 2025. Participants using the t:slim X2 insulin pump with Control-IQ technology achieved 12.6% more time within the pregnancy glucose target range of 3.5–7.8 mmol/L (63–140 mg/dL) compared with those receiving standard therapy. This equated to approximately three additional hours per day in the target range from 16 weeks’ gestation through the end of pregnancy.
The expanded indication for adults with type 2 diabetes is based on results from the 2IQP trial, a randomized controlled study involving more than 300 participants and published in the New England Journal of Medicine in March 2025. The study compared use of the t:slim X2 pump with Control-IQ+ technology against existing insulin regimens.
“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.
In the study, participants using Control-IQ+ achieved a 0.9% reduction in A1C compared with a 0.3% reduction in the control group. Individuals entering the trial with A1C levels of 9% or higher experienced a 2.3% reduction. The technology demonstrated a favorable safety profile, with low rates of hypoglycemia and no reported cases of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.
The t:slim X2 insulin pump is currently available in several European markets, while the Tandem Mobi system is expected to launch in select European countries during the second half of 2026.
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