A team from the Jaeb Center for Health Research, along with other investigators, seeks to evaluate AID in pregnancy with type 1 diabetes. They hope to facilitate a better understanding of real-world type 1 diabetes management during pregnancy.
The Leona M. and Harry B. Helmsley Charitable Trust agreed to fund the “T1D Pregnancy & Me” study. Investigators have recruitment underway for pregnant individuals living with type 1 diabetes who 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. 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,” said Dr. Camille E. Powe, an associate professor at Massachusetts General Hospital and Harvard Medical School and the study’s chair.
According to a news release, intensive insulin therapy has dramatically reduced the risk of mortality that was previously associated with pregnancy in those with type 1 diabetes. However, there remains an elevated risk for maternal and fetal complications. That risk ties directly to blood glucose levels, leading to recommended lower targets for blood glucose in pregnancy. Those lower targets prove more challenging to achieve.
CGM paired with AID systems can improve blood sugar target levels in non-pregnant people with T1D. However, no AID system has FDA clearance for use in pregnancy in the U.S. due to a lack of clinical evidence.
What the study hopes to find related to diabetes in pregnancy
The study aims to fill the current gap in clinical evidence, assessing AID’s impacts on glycemic goals for diabetes in pregnancy and pregnancy outcomes.
Investigators plan to collect CGM data, insulin delivery data and pregnancy outcome data. Evidence could help guide modern management of T1D during pregnancy.
To assess current strategies, researchers aim to enroll at least 500 participants. These participants would reflect the geographic, racial and socioeconomic diversity of people living with T1D in the U.S. The researchers say they expect the study to mark the largest of its kind to date. Ypsomed last year shared findings from its own study of 124 pregnant women using automated insulin delivery.
Additionally, participants can complete the at-home study online without required in-person visits.
“Our goal is to provide data that enhances our understanding of glucose sensor targets and identifies the most effective strategies for managing glucose throughout pregnancy,” added Robin L. Gal, an epidemiologist from the Jaeb Center for Health Research. “We hope this research leads to meaningful improvements in making pregnancy healthier and more manageable for individuals with T1D.”
