Tandem Diabetes Care has received CE mark approval in Europe for its t:slim X2 and Tandem Mobi insulin delivery systems running Control-IQ+ technology, expanding their approved use to two new populations: people with type 1 diabetes during pregnancy and adults with type 2 diabetes. The approval comes after two major clinical trials that demonstrated strong outcomes across both populations.

The pregnancy indication is backed by the CIRCUIT trial, where 91 participants using Control-IQ spent 12.6% more time in the pregnancy-specific glucose target range compared to people on standard therapy, about three extra hours per day. The type 2 indication comes from the 2IQP trial, 300+ People using Control-IQ+ saw a 0.9% reduction in A1C versus 0.3% in the control group, with those starting at an A1C of 9% or higher seeing up to a 2.3% reduction.

As for what comes next, the t:slim X2 is already available in several European countries, while the Tandem Mobi is expected to launch in select European markets in the second half of 2026. Stay tuned as we continue covering everything coming out of American Diabetes Association this weekend.