Automated Insulin Delivery for Pregnancy With Type 1 Diabetes: A Call to Action

Type 1 diabetes (T1D) requires intensive glycemic management in pregnancy with insulin to achieve pregnancy-specific glycemic targets and avoid serious maternal and perinatal morbidity. Glycemic targets for pregnancy, which are lower than those outside pregnancy, are extremely challenging to achieve, resulting in considerable burden and psychosocial distress for pregnant women living with T1D. While automated insulin delivery (AID) is now the recommended mode of insulin delivery for T1D, pregnant women with T1D have been left behind. AID systems approved by the U.S. Food and Drug Administration for use in the U.S. are not designed to meet pregnancy glycemic targets, and most are not labeled for pregnancy. Broad exclusion of pregnant participants from clinical trials, including those of AID systems, has resulted in extremely limited data to guide the use of these devices in pregnancy. Furthermore, for most devices insulin delivery is reduced when continuous glucose monitoring (CGM) sensor values are in the optimal range for fetal well-being. We call on stakeholders to deliver AID systems that meet the needs of pregnant women with T1D so that they can use AID at a time in life when they stand to benefit the most. Specifically, we should include pregnant women in clinical trials of new AID technologies, design AID systems that can meet the unique glycemic management challenges of pregnancy, and support real-world studies of currently approved AID systems while we await pregnancy-specific innovations.