SAN DIEGO, June 5, 2026
Tandem Diabetes Care announced that its t:slim X2 and Tandem Mobi automated insulin delivery (AID) systems powered by Control-IQ+ technology have received CE Mark approval in Europe for expanded indications, including use in people with type 1 diabetes during pregnancy and adults with type 2 diabetes. The regulatory milestone broadens access to Tandem’s advanced insulin delivery technology and supports its mission to improve diabetes management across a wider patient population.
Clinical Evidence Supports Use During Pregnancy
The expanded indication for type 1 diabetes during pregnancy is supported by data from the CIRCUIT trial, a multicenter randomized controlled study published in the Journal of the American Medical Association (JAMA) in 2025. The trial evaluated pregnant women using the t:slim X2 insulin pump with Control-IQ technology compared with those receiving standard insulin therapy through multiple daily injections or conventional pump therapy. Results showed that participants using Control-IQ technology achieved 12.6% more time within the pregnancy glucose target range, equivalent to approximately three additional hours per day, from 16 weeks of gestation through delivery. The findings highlight the potential of automated insulin delivery systems to improve glucose control during pregnancy, a period requiring particularly tight diabetes management.
Positive Results for Adults with Type 2 Diabetes
The CE Mark expansion for adults with type 2 diabetes is based on findings from the landmark 2IQP trial, the first large-scale randomized controlled study of an automated insulin delivery system in more than 300 people with type 2 diabetes. Published in The New England Journal of Medicine in 2025, the study demonstrated that participants using the t:slim X2 pump with Control-IQ+ technology achieved a 0.9% reduction in A1C, compared with 0.3% in the control group. Patients entering the study with baseline A1C levels of 9% or higher experienced reductions of up to 2.3%. The system also demonstrated a favorable safety profile, with low rates of hypoglycemia and no reported cases of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.
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Expanding Access to Advanced Diabetes Technology
Tandem Diabetes Care stated that the approval reinforces the strength of its automated insulin delivery portfolio and supports broader adoption of advanced diabetes technologies across Europe. The t:slim X2 insulin pump is currently available in multiple European markets, while the Tandem Mobi system, described as the world’s smallest durable automated insulin delivery system, is expected to launch in select European countries during the second half of 2026. Both platforms utilize Control-IQ+ technology, which has demonstrated sustained improvements in glycemic control, increased time in range, and better overall diabetes management in multiple clinical studies. The latest CE Mark approvals position Tandem to expand its presence in the growing diabetes technology market while addressing unmet needs in pregnancy-related diabetes care and insulin-dependent type 2 diabetes.
Source: Tandem Diabetes Care press release
