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.
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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.
Published in the Journal of the American Medical Association in October 2025, the randomised controlled, multi-centre trial assessed the t:slim X2 pump combined with Control-IQ technology.
The trial compared the use of the system to standard insulin therapy, either by multiple daily injections or pumps using continuous glucose monitoring.
Participants using the Control-IQ system spent 12.6% more time within the recommended pregnancy glucose target range of 3.5mmol/L-7.8mmol/L (63mg/dL-140mg/dL), or about three hours more per day, from 16 weeks of gestation until delivery, versus those on standard care.
Data from this study are set to be discussed at the 2026 American Diabetes Association Scientific Sessions on 6 June in New Orleans.
For adults with T2D, the approval is supported by the 2IQP trial, which the New England Journal of Medicine published in March 2025. This large-scale, randomised controlled study involved more than 300 participants.
The trial compared the t:slim X2 pump using Control-IQ+ technology to existing insulin regimens, with both groups using the Dexcom G6 continuous glucose monitoring system.
The Control-IQ+ group saw an average reduction in A1C of 0.9%, compared to 0.3% in the control group. In those entering with A1C levels of 9% or higher, the reduction reached 2.3%.
Study results indicated low rates of hypoglycaemia, no new safety concerns, and no diabetic ketoacidosis or hyperosmolar hyperglycaemic syndrome events.
Tandem Diabetes Care president and CEO John Sheridan 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.”
Tandem Diabetes Care’s t:slim X2 is currently available in several European countries while Tandem Mobi is projected to launch in select European markets in the second half of 2026.
In April 2026, Tandem received approval from the US Food and Drug Administration for its Control-IQ+ automated insulin delivery technology to be used during pregnancy in individuals with type 1 diabetes mellitus (T1DM).
