FDA Clears First Automated Insulin System for Type 1 Diabetes in Pregnancy

Trial results point to about three extra hours each day in the pregnancy glucose range with no signal of worse maternal or newborn outcomes.

Overview

Tandem Diabetes Care’s Control-IQ+ won FDA clearance Monday for use during pregnancy on the t:slim X2 and Mobi pumps, making it the first and only U.S. automated insulin delivery system with this indication.
The decision draws on the CIRCUIT randomized trial, which showed a 12.6 percentage-point increase in time spent in the tighter pregnancy target of 63–140 mg/dL, or about three more hours in range per day.
Researchers reported similar maternal and neonatal outcomes between study groups, with two serious adverse events in the Control-IQ arm versus five in standard therapy.
Control-IQ+ adds features the company says fit pregnancy needs, including an extended bolus of up to eight hours, support for a wider range of insulin needs, and new temporary basal rate options.
Tandem plans training events and webinars for clinicians, starting with a product theater at the American Diabetes Association’s June 2026 meeting in New Orleans, which could speed adoption in prenatal care.