Tandem Diabetes Wins CE Mark for AID Systems in Europe After FDA Pregnancy Approval

Tandem Diabetes Care has received expanded CE mark approval for its Control-IQ-powered automated insulin delivery systems in Europe, allowing the technology to be used by adults with type 2 diabetes and those with type 1 diabetes during pregnancy. The approval covers the company's flagship t:slim X2 and miniature Mobi insulin pumps.

The European regulatory milestone follows FDA approvals in the United States for type 2 diabetes indications in early 2025 and for pregnancy just over a month ago. The FDA clearance specifically applies to use during pregnancy in individuals with type 1 diabetes mellitus, based on findings from the randomised controlled CIRCUIT trial published in the Journal of the American Medical Association (JAMA) in October 2025.

In the CIRCUIT trial, pregnant participants with type 1 diabetes either used the t:slim X2 pump with Control-IQ technology or continued on their existing regimen of multiple daily injections or insulin pumps with continuous glucose monitoring. The Control-IQ group experienced a 12.6% increase in time spent within the pregnancy-specific glucose target range of 63mg/dL–140mg/dL, equating to approximately three additional hours per day from 16 weeks' gestation until delivery. Researchers reported that maternal and neonatal outcomes were broadly comparable in both groups but were more favourable among those on the Control-IQ system.

For the type 2 diabetes indication, Tandem supported its label expansion with clinical evidence from the 2IQP trial of more than 300 people. The study compared t:slim X2 with Control-IQ+ to a control group continuing multiple daily injections, with both groups using a Dexcom G6 continuous glucose monitor. People using Control-IQ+ achieved a 0.9% reduction in A1C, compared to 0.3% in the control group.

The CIRCUIT trial principal investigator from the University of Calgary noted that marked glycaemic improvements occurred within the first week of initiating Control-IQ and persisted for the duration of pregnancy. Improvements were found across all sites and baseline HbA1c ranges, regardless of whether participants used an insulin pump or multiple daily insulin injections at enrolment.

Tandem plans to share data from the CIRCUIT trial at the American Diabetes Association Scientific Sessions in New Orleans. The company also announced in June 2025 that the t:slim X2 insulin pump became compatible with Abbott's FreeStyle Libre 3 Plus CGM sensor.