Pregnant women with type 1 diabetes require stringent, pregnancy-specific glycemic targets that are currently unmet by available automated insulin delivery (AID) systems.
FDA-approved AID devices are not designed or labeled for use during pregnancy, largely due to the exclusion of pregnant women from clinical trials.
Current AID systems reduce insulin delivery when glucose sensors indicate optimal fetal well-being range, which may not align with tighter pregnancy targets, risking suboptimal glucose control.
A coordinated call to action urges inclusion of pregnant women in AID clinical trials, the development of pregnancy-tailored AID systems, and real-world studies to improve outcomes in this vulnerable population.