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Tandem Diabetes Care has received CE mark expansion in Europe for its Control-IQ+ automated insulin delivery (AID) systems, enabling use in adults with type 2 diabetes and people with type 1 diabetes during pregnancy.
The approval covers the company’s t:slim X2 and Tandem Mobi insulin pumps, which automatically adjust insulin delivery based on continuous glucose monitoring data.
The expanded pregnancy indication is supported by the CIRCUIT trial, which showed improved glycemic control, including about 3 additional hours per day in target glucose range compared with standard therapy.
For type 2 diabetes, approval is based on the 2IQP randomized controlled trial, which included over 300 participants and demonstrated a greater reduction in HbA1c (0.9% vs 0.3%) in the AID group, with no new safety signals or severe hypoglycemia-related events reported.
CEO John Sheridan said:
“By expanding access to our AID technology, we’re broadening our impact and advancing our mission to improve lives across the diabetes community.”
The expanded label significantly broadens the clinical use of Tandem’s automated insulin systems in Europe, extending beyond type 1 diabetes into two major additional patient populations with high unmet needs.
