FDA clears Control-IQ+AID technology for use in pregnancy complicated by type 1 diabetes

On April 27, 2026, Tandem Diabetes Care announced the expanded FDA clearance of the Control-IQ+ automated insulin delivery (AID) technology for use in pregnancies complicated by type 1 diabetes mellitus. This regulatory clearance covers both the t:slim X2 and Tandem Mobi insulin delivery systems, making them the first and only commercially available AID systems in the United States cleared for use during pregnancy, according to a news release from the company.¹

The expanded label indication is supported by data from the CIRCUIT trial, published in the Journal of the American Medical Association (JAMA) in October 2025. In this multicenter, randomized controlled trial, 88 participants were assigned to either use a t:slim X2 insulin pump with Control-IQ technology or to continue their standard therapy, which consisted of either multiple daily insulin injections or an insulin pump with continuous glucose monitoring.

Mean percentage of time spent in the pregnancy-specific glucose range was 65.4% in the closed-loop group and 50.3% in the standcard care group. This led to, from 16 weeks of gestation through the end of pregnancy, the Control-IQ group experiencing 12.6% (P < .001) more time in the pregnancy glucose target range of 63–140 mg/dL, which equates to approximately 3 hours more per day vs those in the standard therapy group.

Overall, maternal and neonatal outcomes were similar between the groups, though they trended in favor of the Control-IQ technology.^1,2

“In the CIRCUIT trial, glycemic improvements were found across all sites and baseline HbA1c ranges, regardless of whether an insulin pump or multiple daily insulin injections were used at enrollment,” said Lois Donovan, MD, principal investigator of the CIRCUIT study and Clinical Professor at the University of Calgary, in a statement.

These results led the authors to conclude that findings supported the use of this closed-loop system in pregnant women with T1D.²

“Glycemic goals are tighter during pregnancy,” added 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.”¹

Going forward, Tandem Diabetes Care will perform a series of training events and webinars for health care providers of pregnancy and T1D management, with the first event taking place at the American Diabetes Association 2026 Scientific Sessions meeting in New Orleans, Louisiana, in June.

References:

1. Tandem Diabetes Care’s Control-IQ+ Automated Insulin Delivery Technology new FDA cleared for pregnancy in type 1 diabetes. Tandem Diabetes Care, Inc. News release. Published April 27, 2026. Accessed April 27, 2026. https://investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-cares-control-iq-automated-insulin-delivery
2. Donovan LE, Lemieux P, Dunlop AD, et al. Closed-Loop Insulin Delivery in Type 1 Diabetes in Pregnancy: The CIRCUIT Randomized Clinical Trial. JAMA. 2025;334(24):2176–2185. doi:10.1001/jama.2025.19578