Tandem’s AID cleared for pregnancies complicated by Type 1 diabetes mellitus
By HME News Staff
Updated 9:39 AM CDT, Wed April 29, 2026
SAN DIEGO – Tandem Diabetes Care has announced that the U.S. Food and Drug Administration (FDA) has cleared Control-IQ+ automated insulin delivery (AID) technology for use in pregnancy complicated by Type 1 diabetes mellitus. Control-IQ+ powers both insulin delivery systems from Tandem – the t:slim X2 and Tandem Mobi, the first and only commercially available AID systems cleared for use during pregnancy in the United States. “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.” This expanded label indication for use in Type 1 diabetes during pregnancy is based on results from the CIRCUIT trial published in Journal of the American Medical Association (JAMA) in October 2025. Participants in this multi-center, randomized controlled trial were assigned to use a t:slim X2 insulin pump with Control-IQ technology or to continue their multiple daily insulin injections or insulin pump with continuous glucose monitoring. The Control-IQ group experienced 12.6% more time in the pregnancy glucose target range 63-140 mg/dL, approximately three hours more per day, compared to those using their standard therapy, from 16 weeks’ gestation to the end of pregnancy. Maternal and neonatal outcomes were similar in both groups overall but favored those using Control-IQ.
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