Tandem Diabetes Care Control-IQ+ has received FDA clearance for pregnancy use in people with type 1 diabetes. As a result, the company expands access to automated insulin delivery systems in the U.S. Moreover, Tandem Diabetes Care Control-IQ+ powers both the t: slim X2 and Tandem Mobi systems. These products are now the first and only commercially available AID systems cleared for pregnancy use in the United States. Furthermore, the approval marks a major step in diabetes care technology. It also supports safer glucose management during 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 expanded indication is based on findings from the CIRCUIT trial. The study appeared in the Journal of the American Medical Association in October 2025.
Researchers conducted a multi-center randomized controlled trial using different treatment groups. Participants either used a t:slim X2 insulin pump with Control-IQ technology or continued standard therapy. In addition, standard therapy included multiple daily insulin injections or insulin pumps with continuous glucose monitoring.
The Control-IQ group recorded 12.6% more time in the pregnancy glucose target range of 63-140 mg/dL. This equals nearly three extra hours each day. The study tracked participants from 16 weeks gestation until the end of pregnancy. Meanwhile, maternal and neonatal outcomes were similar overall. However, results favored those using Control-IQ technology.
CIRCUIT Trial Shows Strong 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.
Additionally, Tandem Diabetes Care plans several training events and webinars for healthcare providers. These programs will focus on pregnancy and type 1 diabetes management. The first event will be the Tandem product theater at the American Diabetes Association 2026 Scientific Sessions in New Orleans, Louisiana, in June. The company said experts will discuss study findings and practical treatment strategies during the event.
Previously, major studies published by the New England Journal of Medicine also highlighted Control-IQ technology benefits. These studies appeared in October 2019, August 2020, March 2023, and March 2025.Those reports showed immediate and lasting glycemic improvements. They also reported more time in range and better sleep outcomes.
Explore Health Tech Insiders for the latest medical innovations and reliable strategic insights driving the future of technology-driven healthcare transformation.
News Source: Businesswire.com
