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FDA cleared Control-IQ+ for pregnancy in type 1 diabetes, expanding automated insulin delivery options during gestation.
The US Food and Drug Administration (FDA) has cleared Tandem Diabetes Care’s Control-IQ+ automated insulin delivery technology for use during pregnancy complicated by type 1 diabetes, expanding the label for the company’s t:slim X2 and Tandem Mobi systems.
According to the company, this makes Control-IQ+ the first commercially available automated insulin delivery system in the US with a pregnancy indication.
“Glycemic goals are tighter during pregnancy,” said Jordan Pinsker, MD, 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 clearance was based on the CIRCUIT randomized clinical trial, published in JAMA in 2025. In the multicenter study, pregnant individuals with type 1 diabetes were assigned either to a t:slim X2 pump using Control-IQ technology or to standard therapy consisting of multiple daily injections or insulin pump therapy with continuous glucose monitoring.
From 16 weeks’ gestation to the end of pregnancy, participants using Control-IQ spent 12.6% more time in the prespecified pregnancy glucose target range of 63 to 140 mg/dL, about 3 additional hours per day, than those receiving standard care, according to the press release and trial publication.
Type 1 diabetes in pregnancy remains a high-risk clinical setting. Current guidelines recommend stringent glucose targets during gestation because hyperglycemia is associated with congenital anomalies, preeclampsia, large-for-gestational-age birthweight, neonatal hypoglycemia, and other complications.^2 Continuous glucose monitoring has improved management in this population and is recommended by major professional societies, but achieving targets remains difficult for many patients despite intensive insulin therapy.^2,3
Automated insulin delivery has been increasingly adopted outside pregnancy, supported by randomized trials showing improved time in range and lower mean glucose levels compared with sensor-augmented pump therapy or standard care in children and adults with type 1 diabetes.^4
However, pregnancy has posed a specific regulatory and clinical gap because algorithms developed for nonpregnant users may not reflect gestational insulin resistance, tighter glucose thresholds, and fetal safety considerations. The new clearance helps to address this gap, although its use remains contingent on pairing the pump with a continuous glucose monitoring system suitable for pregnancy, according to the updated indication in the company announcement.
Control-IQ+ is an advanced hybrid closed-loop system that adjusts basal insulin based on continuous glucose monitor readings and predicted glucose values and can deliver correction boluses when glucose is expected to exceed a set threshold. Before this pregnancy expansion, the technology was already indicated for management of type 1 diabetes in patients aged 2 years or older and type 2 diabetes in adults, according to the release.
Important questions remain. The company said maternal and neonatal outcomes were similar overall between groups, although they favored Control-IQ; detailed outcome data and absolute event rates are best interpreted from the published trial rather than the press release alone.
