The FDA has cleared Tandem Diabetes Care’s Control-IQ+ technology for use in pregnancies involving type 1 diabetes, marking the first automated insulin delivery (AID) system in the U.S. approved for this indication. The expanded approval covers both the t:slim X2 and Tandem Mobi systems, offering expectant mothers a more advanced option for managing the tighter glucose targets required during pregnancy. Traditionally, patients have relied on manual methods such as multiple daily injections or standard insulin pumps, which lack the ability to automatically adjust insulin delivery to meet pregnancy-specific needs.
The approval is supported by data from the CIRCUIT trial, which demonstrated meaningful improvements in glucose control among users of the Control-IQ+ system. Participants spent significantly more time within the recommended pregnancy glucose range of 63–140 mg/dL—equivalent to roughly three additional hours per day—compared to those on standard therapy. These benefits were seen quickly, within the first week of use, and were maintained throughout pregnancy, with improved maternal and neonatal outcomes compared to traditional treatment approaches. The system’s ability to adapt to physiological changes, such as increasing insulin resistance in later trimesters, highlights its clinical value.
Beyond the approval, Tandem is working to support adoption by launching educational initiatives aimed at healthcare providers, including maternal-fetal specialists and endocrinologists. This effort underscores the importance of integrating AID systems into prenatal care and ensuring clinicians are equipped to use them effectively. The expanded indication builds on a strong body of research supporting the Control-IQ platform and represents a significant step forward in addressing an unmet need in diabetes care during pregnancy.
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