Why Automated Insulin Delivery Needs to Catch Up for Pregnant Women With Type 1 Diabetes

Women with Type 1 diabetes who become pregnant face a unique challenge: their blood sugar targets become significantly stricter. The glycemic targets during pregnancy are considerably lower than those for non-pregnant individuals, which means achieving and maintaining safe blood sugar levels requires more intensive management.

This heightened control is necessary to protect both mother and baby. Uncontrolled blood sugar during pregnancy increases the risk of serious complications for both the pregnant person and the developing fetus. The stakes are high, and the workload is substantial.

Automated insulin delivery (AID) systems—also called artificial pancreas or closed-loop systems—have become the recommended approach for managing Type 1 diabetes. These devices combine an insulin pump, continuous glucose monitor, and algorithms to automatically adjust insulin delivery throughout the day and night.

Yet the FDA-approved AID systems available in the U.S. were not designed with pregnancy in mind. Most are not even labeled for use during pregnancy. This creates a critical mismatch: the women who could benefit most from automation during their most demanding period of diabetes management are essentially left without these tools.

Part of the reason for this gap is straightforward but troubling: pregnant women have been broadly excluded from the clinical trials that test and refine automated insulin delivery systems. This means there is extremely limited evidence about how well these devices work during pregnancy or how to optimize them for pregnancy-specific needs.

The lack of evidence creates a catch-22. Without robust data from pregnant users, device manufacturers are hesitant to label systems for pregnancy. Without labeled systems designed for pregnancy, researchers struggle to generate that evidence.

Adding another layer of complexity, some current automated systems are programmed to reduce insulin delivery when blood sugar readings fall into the optimal range for fetal well-being. While this safety feature makes sense in other contexts, during pregnancy it can paradoxically work against achieving the tight control that pregnancy demands.

This contradiction underscores how much current AID systems were built for patients without pregnancy, and how urgently they need to be reimagined for those who do.

Experts and advocates are calling for a multipronged approach. First, pregnant women should be included in clinical trials of new and existing automated insulin delivery technologies. This is essential for generating real-world evidence and understanding how these systems perform during pregnancy.

Second, device manufacturers should design AID systems specifically to meet the unique glycemic management challenges of pregnancy, including algorithms and targets tailored to pregnancy-specific needs.

Third, real-world studies of currently approved systems should be supported to better understand how they can be used effectively during pregnancy, even before pregnancy-specific innovations are available.

The goal is clear: pregnant women with Type 1 diabetes deserve access to the same technological advances in insulin delivery that have become standard care for others with Type 1 diabetes—especially at a time in life when they stand to benefit the most.

Source: Diabetes care. Evidence type: PubMed indexed literature. Type1Cure is an information and intelligence hub, not a medical advice service. This article summarizes published research and does not provide diagnosis, treatment, or personal medical guidance. Always talk to your own care team before changing anything about your Type 1 diabetes management.