Tandem Diabetes’ Insulin Pumps Win EU Nods for T2D, T1D in Pregnancy

Tandem Diabetes Care has received CE mark approval to expand the indications of its automated insulin delivery (AID) systems in Europe. The t:slim X2 and Tandem Mobi insulin pumps running Control-IQ+ AID tech are now approved for people with type 1 diabetes during pregnancy and adults with type 2 diabetes.

The expanded label for type 1 diabetes during pregnancy is based on results from the CIRCUIT trial published in October 2025. Participants were assigned to use a t:slim X2 pump with Control-IQ or continue their multiple daily insulin injections or insulin pump with continuous glucose monitoring (CGM).

The Control-IQ group has 12.6% more time in the pregnancy glucose target range 3.5-7.8 mmol/L (63-140 mg/dL)—about three hours more each day—compared to the standard therapy group, from 16 weeks gestation to the end of pregnancy.

In April, the Control-IQ+ algorithm earned U.S. Food and Drug Administration (FDA) clearance for type 1 diabetes in pregnancy.

The expanded indication for adults with type 2 diabetes is based on clinical evidence from the first large-scale, randomized controlled study of an AID system in type 2 diabetes (the 2IQP trial), completed in over 300 people with type 2 diabetes and published in March 2025. The trial compared using a t:slim X2 pump with Control-IQ+ to a control group who kept their existing insulin regimen.

Both groups used a Dexcom G6 CGM system during the study. People using Control-IQ+ has a 0.9% reduction in A1C compared to 0.3% in the control group, with those entering the study at A1C levels of 9% or higher experiencing a 2.3% reduction. The tech was demonstrated to be safe, with low rates of hypoglycemia, no new safety signals identified, and no diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome events reported.

“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 CEO of Tandem. “By expanding access to our AID technology, we’re broadening our impact and advancing our mission to improve lives across the diabetes community.”