Insulin delivery and diabetes technology company Tandem Diabetes Care Inc (Nasdaq:TNDM) announced on Friday that it has received CE mark approval in Europe for expanded indications of its automated insulin delivery systems, enabling use in adults with type 2 diabetes and women with type 1 diabetes during pregnancy.

This approval covers the t:slim X2 and Tandem Mobi systems powered by Control-IQ+ technology.

The type 1 diabetes pregnancy indication is supported by results from the CIRCUIT trial published in the Journal of the American Medical Association in October 2025, which showed a 12.6% increase in time spent in the pregnancy glucose target range (63–140 mg/dL), equivalent to around three additional hours per day versus standard therapy, from 16 weeks gestation to delivery. Findings from the CIRCUIT trial are scheduled to be presented at the 2026 American Diabetes Association Scientific Sessions in New Orleans.

The type 2 diabetes indication is based on the 2IQP randomised controlled trial published in the New England Journal of Medicine in March 2025, involving more than 300 participants using either the t:slim X2 system with Control-IQ+ or standard insulin regimens alongside Dexcom G6 continuous glucose monitoring. The study showed A1C reductions of 0.9% versus 0.3% in controls, with a 2.3% reduction in participants with baseline A1C of 9% or higher, alongside a safety profile with low hypoglycaemia and no diabetic ketoacidosis or hyperosmolar hyperglycaemic events reported.

The t:slim X2 insulin pump is currently available in several European countries, with Tandem Mobi expected to launch in selected countries in the second half of 2026.