Tandem’s Control-IQ+ Cleared for Pregnancy with Type 1 Diabetes
Tandem announced that the FDA has cleared Control-IQ+ automated insulin delivery technology for use in pregnancy and type 1 diabetes.
That matters because pregnancy with type 1 is not just regular diabetes with a baby involved. The targets are tighter, insulin needs can change quickly, and the whole thing asks more from people who are already doing a lot.
Control-IQ+ powers both Tandem insulin delivery systems, the t:slim X2 and Tandem Mobi. Tandem says this makes them the first and only commercially available automated insulin delivery systems cleared for pregnancy use in the United States.
The clearance follows the CIRCUIT trial, where people using t:slim X2 with Control-IQ spent 12.6% more time in the pregnancy glucose target range of 63–140 mg/dL compared with standard therapy. That works out to about three extra hours per day in range. If you’ve ever stared at a CGM graph like it personally owes you an apology, you know three hours is not nothing.
This also connects to conversations I’ve had on the podcast about pregnancy with type 1, and to episode #1826, “Re-thinking Control IQ Plus Technology.”Automated insulin delivery can be incredibly helpful, but it is not magic. Settings still matter. Correction factors matter. Starting fresh when switching pump systems matters.
Tandem also noted that maternal and neonatal outcomes were similar overall between groups, but favored those using Control-IQ. That keeps this where it belongs: encouraging, useful, and real.
For people managing type 1 during pregnancy, and for the clinicians helping them, this feels like meaningful progress.
Not magic. A tool. But a tool cleared for a moment in life that deserves better tools.
