Studying Automated Insulin Delivery in Pregnant Women with Diabetes

In an industry first, a team led by Dr. Camille E. Powe, an associate professor at Massachusetts General Hospital and Harvard Medical School, is striving to bring precision medicine to the realm of maternal health. This game-changing research focuses on pregnant women with type 1 diabetes (T1D), a demographic traditionally side-lined in diabetes care trials, thus leaving a significant knowledge gap in the utilization of emerging technologies during pregnancy.

This pioneering study seeks to evaluate the efficacy of Automated Insulin Delivery (AID) systems in improving pregnancy outcomes for this at-risk group. The goal? To revolutionize treatment protocols, thereby ensuring optimal health outcomes for both mother and baby.

A previous study has shown that the mylife Loop system, an AID device, can notably enhance the health of pregnant women with T1D. Building on this foundation, researchers and top-tier diabetes in pregnancy investigators have now initiated an observational study of AID implementation during pregnancy. The team comprises leading experts from the Jaeb Center for Health Research, who are committed to deepening our understanding of real-world T1D management during pregnancy.

The ambitious “T1D Pregnancy & Me” study, generously funded by the Leona M. and Harry B. Helmsley Charitable Trust, is currently recruiting pregnant individuals living with T1D who already use continuous glucose monitors (CGMs).

“Pregnant women are usually excluded from clinical trials studying the latest advances in diabetes care, leading to uncertainty on how new technologies should be used during pregnancy,” warns Dr. Powe. “Our study will provide valuable evidence on outcomes achievable with currently available AID devices and will enable new innovations to optimize pregnancy outcomes for people living with T1D and their babies.”

Despite major advancements in insulin therapy that have significantly reduced the risk of mortality associated with pregnancy in T1D patients, maternal and fetal complications remain a stark reality. These risks are directly linked to blood glucose levels, which are more challenging to control during pregnancy due to lower targets recommended for blood glucose.

CGMs paired with AID systems have shown promise in improving blood sugar target levels in non-pregnant individuals with T1D. Yet, there is no AID system with FDA clearance for use in pregnancy in the U.S., primarily due to a lack of clinical evidence. Dr. Powe’s groundbreaking study could be the missing piece of the puzzle, providing the much-needed clinical evidence to bridge this gap and potentially change the narrative for diabetic women during pregnancy.

In a nutshell, this research could be a critical step toward more personalized, precision-based diabetes management in pregnant women, aligning with broader industry trends toward individualized care. It signifies a move away from the one-size-fits-all approach, towards a future where care is tailored to individual patient needs, even during pregnancy.