Tandem Diabetes’ Control-IQ+ Wins FDA Nod for T1D in Pregnancy

Tandem Diabetes Care announced that the U.S. Food and Drug Administration (FDA) cleared its Control-IQ+ automated insulin delivery (AID) tech for use in pregnancy complicated by type 1 diabetes mellitus.

Control-IQ+ powers both of the company’s insulin delivery systems. These are the t:slim X2 and Tandem Mobi, the first and only commercially available AID systems cleared for use during pregnancy in the U.S.

The expanded label was based on results from the CIRCUIT trial publish in Journal of the American Medical Association (JAMA) in October 2025. Participants were assigned to a t:slim X2 pump with Control-IQ technology or to continue their multiple daily insulin injections or insulin pump with continuous glucose monitoring.

The Control-IQ group had 12.6% more time in the pregnancy glucose target range of 63-140 mg/dL (about three hours more per day) compared to those using their standard therapy, from 16 weeks gestation to the end of pregnancy.

“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.”

The company said maternal and neonatal outcomes were similar in both groups overall but favored those using Control-IQ.

“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 Dr. Lois Donovan, principal investigator of the CIRCUIT study and Clinical Professor at the University of Calgary. “Marked glycemic improvements occurred within the first week of initiation of Control-IQ that persisted for the duration of pregnancy.”

Tandem said it will perform a series of training events and webinars for healthcare providers related to pregnancy and type 1 diabetes management.

In November, the company received FDA clearance for the Android version of the Tandem Mobi mobile app.