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The FDA has cleared the first automated insulin delivery (AID) system technology for use in pregnancies complicated by type 1 diabetes (T1D).
On April 27, 2026, the FDA cleared Tandem Diabetes Care’s Control-IQ+ technology, which powers both the t:slim X2 and Mobi insulin pumps. The algorithm allows for the tighter glycemic targets recommended to optimize pregnancy outcomes.
Clearance was based on findings from the multicenter, randomized, open-label CIRCUIT trial published in JAMA in October 2025. A total of 91 pregnant women with T1D were randomized to use a t:slim X2 insulin pump with Control-IQ+ technology or continue with their usual therapy, either multiple daily injections or insulin pump, both with continuous glucose monitoring.
The mean percentage of time spent in the pregnancy-specific glucose range (63-140 mg/dL) from 16 to 34 weeks’ gestation was 65.4% in the AID group vs 50.3% in the standard care group, a statistically significant difference.
“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 CIRCUIT principal investigator Lois Donovan, MD, of the University of Calgary, Alberta, in a Tandem statement.
Tandem Diabetes Care will be conducting training events and webinars for healthcare providers related to T1D management during pregnancy. The first event will take place at the upcoming American Diabetes Association’s annual scientific sessions in New Orleans.
Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker and BlueSky @miriametucker.bsky.social
