First Automated Insulin Delivery System Cleared for Type 1 Diabetes in Pregnancy

Managing glycemia during pregnancy complicated by type 1 diabetes requires tight targets and sustained time in a pregnancy-specific glucose range. Clinicians and patients often rely on automated insulin delivery systems to support intensive glucose control alongside continuous glucose monitoring. A new system has received U.S. Food and Drug Administration (FDA) clearance as the first and only commercially available automated insulin delivery option for pregnancy in the United States.

Control-IQ+ automated insulin delivery (AID) technology from Tandem Diabetes Care powers both the t:slim X2 insulin pump and the Tandem Mobi system. The new clearance authorizes Control-IQ+ for use in pregnancy complicated by type 1 diabetes mellitus. With this decision, t:slim X2 and Tandem Mobi become the first and only commercially available AID systems cleared for pregnancy use in the U.S.

Control-IQ+ is designed to integrate with compatible integrated continuous glucose monitors and alternate controller enabled pumps. The algorithm automatically increases, decreases, or suspends basal insulin based on real-time readings and predicted glucose values. It can also deliver automated correction boluses when glucose is predicted to exceed a predefined threshold.

The expanded indication is supported by the multicenter, randomized CIRCUIT clinical trial, published in JAMA in October 2025. Participants were assigned either to a t:slim X2 pump with Control-IQ technology or to continue standard therapy with multiple daily injections or an insulin pump with continuous glucose monitoring. From 16 weeks’ gestation through delivery, participants using Control-IQ spent 12.6% more time in the pregnancy glucose target range of 63–140 mg/dL—approximately three additional hours per day—while maternal and neonatal outcomes were similar overall but favored Control-IQ.

Tandem Diabetes Care plans a series training events and webinars for healthcare professionals focused on pregnancy and type 1 diabetes management. The first event will be a product theater at the American Diabetes Association 2026 Scientific Sessions in New Orleans in June, discussing the study results. 

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

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