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Diabetes Tech Expands to T2D and Pregnancy in Europe
8 Jun
Summary
- Insulin pumps now approved for type 2 diabetes adults in Europe.
- Type 1 diabetes patients can use pumps during pregnancy in Europe.
- CE mark follows successful trials for new patient indications.
Tandem Diabetes Care has secured a CE mark for its t:slim X2 and Tandem Mobi insulin pumps with Control-IQ+ technology, expanding their use in Europe. The updated indications now cover adults with type 2 diabetes (T2D) and individuals with type 1 diabetes (T1D) who are pregnant.
These expanded approvals stem from recent clinical studies. The 2IQP trial demonstrated significant A1C reductions in adults with T2D using the t:slim X2 pump and Control-IQ+ technology. For pregnant T1D patients, the CIRCUIT trial showed increased time within target glucose ranges compared to standard care.
Data from the CIRCUIT trial, published in October 2025, indicated participants using the Control-IQ system spent about three additional hours per day within the recommended pregnancy glucose target range. The 2IQP trial, published in March 2025, reported an average A1C reduction of 0.9% in the Control-IQ+ group for T2D patients.
The t:slim X2 pump is available in several European countries, with Tandem Mobi projected to launch in select European markets in the second half of 2026. This follows the US FDA approval in April 2026 for the Control-IQ+ technology for use during pregnancy in T1DM patients.
