The FDA has cleared Tandem's Control IQ+ automated insulin delivery (AID) technology for use during pregnancy in people with type 1 diabetes, making it the first and only commercially available AID system approved for pregnancy use in the United States. Control IQ+ is an advanced algorithm designed for the Tandem t:slim X2 and Mobi insulin pumps.

The clearance stems from the CIRCUIT trial, a randomized study comparing the t:slim X2 insulin pump with standard insulin therapy plus continuous glucose monitoring (CGM) in pregnant women. The trial tracked glucose levels from 16 to 34 weeks of gestation through 6 weeks postpartum. Results showed that the t:slim X2 increased time-in-range (TIR) by 12.6%, or roughly 3 extra hours per day in range, from 16 weeks through delivery. According to Tandem, the benefits were consistent across baseline therapy and HbA1c groups.

Tandem has several products in development, including a tubeless version of the Mobi, a patch pump called the Sigi, and the next-generation t:slim X3. The pregnancy clearance adds to a growing list of milestones for the company as it expands.