The FDA cleared the company’s Control-IQ AID technology for use in pregnancy complicated by type 1 diabetes mellitus. Control-IQ+ powers both of Tandem’s available t:slim X2 and Mobi AID systems. San Diego-based Tandem says t:slim X2 and Mobi are the first and only commercially available AID systems cleared for use during pregnancy in the U.S.
Control-IQ+ represents the next generation of the company’s advanced hybrid closed-loop insulin delivery algorithm. It accommodates a wider range of insulin requirements and has enhanced extended bolus capabilities up to eight hours when turned on. Control-IQ+ allows for better meal management with delayed glucose rise or prolonged eating. New temporary basal rate adjustments also address short-term glucose needs like exercise, stress or illness.
“Glycemic goals are tighter during pregnancy,” said Dr. Jordan Pinsker, chief medical officer at Tandem Diabetes Care. “The higher time in the pregnancy-specific glucose range seen with Control-IQ can help improve pregnancy outcomes.”
Tandem supported its label expansion with results from its CIRCUIT trial published in Journal of the American Medical Association (JAMA) in October 2025. 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 perform a series of events and webinars for healthcare providers related to pregnancy and type 1 diabetes management. It plans for its first to take place at ADA 2026 in New Orleans.
