Tandem Diabetes Care has received approval from the US Food and Drug Administration (FDA) for its Control-IQ+ automated insulin delivery technology to be used during pregnancy in individuals with type 1 diabetes mellitus (T1DM).
This clearance applies to the t:slim X2 and Tandem Mobi insulin delivery systems, which are powered by Control-IQ+.
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The approval is based on findings from the randomised controlled CIRCUIT trial published in the Journal of the American Medical Association (JAMA) in October 2025.
In the trial, pregnant participants with T1D either used the t:slim X2 pump with Control-IQ technology or continued on their existing regimen of multiple daily injections or insulin pumps with continuous glucose monitoring (CGM).
The group using Control-IQ experienced a 12.6% increase in time spent within the pregnancy-specific glucose target range of 63mg/dL-140mg/dL, which equates to approximately three additional hours a day, from 16 weeks’ gestation until delivery.
Researchers reported that maternal and neonatal outcomes were broadly comparable in both groups but were more favourable among those on the Control-IQ system.
Tandem Diabetes Care chief medical officer Dr Jordan Pinsker said: “Glycaemic goals are tighter during pregnancy. The higher time in the pregnancy-specific glucose range seen with Control-IQ can help improve pregnancy outcomes.”
University of Calgary clinical professor and the CIRCUIT study principal investigator Dr Lois Donovan said: “In the CIRCUIT trial, glycaemic improvements were found across all sites and baseline HbA1c ranges, regardless of whether an insulin pump or multiple daily insulin injections were used at enrolment.
“Marked glycaemic improvements occurred within the first week of initiation of Control-IQ that persisted for the duration of pregnancy.”
In June 2025, Tandem Diabetes Care announced its Tandem t:slim X2 insulin pump was compatible with Abbott’s FreeStyle Libre 3 Plus CGM sensor.
