San Diego-based Tandem can now bring its Control-IQ-powered AID systems — the flagship t:slim X2 and miniature Mobi — to European adults with type 2 diabetes and those with type 1 diabetes during pregnancy. Approval in Europe follows FDA nods for type 2 in early 2025 and for pregnancy just over a month ago.
Tandem supported its type 2 label expansion with strong clinical evidence from its 2IQP trial of more than 300 people. The study compared t:slim X2 with Control-IQ+ to a control group continuing multiple daily injections (MDI). Both groups in the study used a Dexcom G6 continuous glucose monitor (CGM). In the pivotal study, people using Control-IQ+ achieved a 0.9% reduction in A1C, compared to 0.3% in the control.
For its approval in pregnancy, the company used findings from its CIRCUIT trial, published last fall. Findings demonstrated 12.6% more time in the pregnancy glucose target range (63-140 mg/dL), approximately three hours more per day, compared to those on standard therapy from 16 weeks gestation to the end of pregnancy.
The company also shared findings supporting the use of its technology during pregnancy at ADA 2025.
Tandem plans to share data from CIRCUIT at this week’s American Diabetes Association Scientific Sessions (ADA 2026) in New Orleans.
Commentary from Tandem officials
John Sheridan, Tandem president and CEO, said:
“These expanded indications underscore the strength of our portfolio and our commitment to bringing innovative diabetes technology to more people worldwide. By expanding access to our AID technology, we’re broadening our impact and advancing our mission to improve lives across the diabetes community.”
Dr. Jordan Pinsker, chief medical officer, added:
“The benefits of Control-IQ+ technology were evident across an incredibly diverse population of people with type 2 diabetes, regardless of pre-study glycemic control or experience with diabetes technology.”
