Tandem Diabetes Care has received a CE mark for expanded indications of its automated insulin delivery (AID) systems in Europe.
The regulatory clearance covers the t:slim X2 and Tandem Mobi insulin pumps with Control-IQ+ technology, enabling their use for adults with type 2 diabetes (T2D) and for patients with type 1 diabetes (T1D) during pregnancy.
The CE mark for these new indications follows recent clinical findings. For pregnant individuals with T1D, the expansion is based on data from the CIRCUIT trial.