Researchers at the Jaeb Center for Health Research along with leading diabetes in pregnancy investigators from across the country have opened an observational study to evaluate automated insulin delivery (AID) in pregnancy with type 1 diabetes. The aim is to facilitate a better understanding of real-world type 1 diabetes (T1D) management during pregnancy. Funded by The Leona M. and Harry B. Helmsley Charitable Trust, the T1D Pregnancy & Me study is currently recruiting pregnant individuals living with T1D 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,” says Camille E. Powe M.D., an Associate Professor at Massachusetts General Hospital and Harvard Medical School and the study’s Chair.
Over the past century, intensive insulin therapy has dramatically reduced the risk of mortality that was previously associated with pregnancy in people with T1D. However, there is still an elevated risk for maternal and fetal complications. Because this risk is tied to blood glucose levels, guidelines recommend lower targets for blood glucose in pregnancy. These targets are extremely challenging to achieve in practice due to risk of hypoglycemia and additional glycemic variability associated with pregnancy. While CGM paired with AID systems have been shown to improve blood sugar target levels in non-pregnant people with T1D, no AID system is FDA-cleared for use in pregnancy in the US due to a lack of clinical evidence and inability to translate their use to the glycemic needs of obstetric care. This study aims to fill that gap and assess AID’s impacts on glycemic goals for T1D in pregnancy and pregnancy outcomes. Through the collection of CGM data, insulin delivery data, and pregnancy outcome data, the study will provide much needed evidence to guide modern management of T1D during pregnancy.
“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, M.S.P.H., 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.”
To assess current T1D management strategies for pregnant patients, researchers aim to enroll at least 500 participants who reflect the geographic, racial, and socioeconomic diversity of people living with T1D in the US. The study is expected to be the largest of its kind to date. Pregnant individuals with T1D who use CGM (regardless of insulin delivery method) are invited to self-enroll in the study online. This at-home study can be completed online and in person visits are not required. The data collected for this study will be made accessible to T1D-related researchers in the fields of, but not limited to, endocrinology, obstetrics and maternal-fetal medicine, and engineering.
“At Helmsley, we are focused on improving the lives of all people living with T1D. The T1D Pregnancy & Me study will address a huge gap in our understanding of the challenges faced by pregnant individuals with T1D and improve the care they receive in their AID systems and at the clinic,” Sean Sullivan, PhD, Type 1 Diabetes Program Officer at the Helmsley Charitable Trust.
Please contact T1DPregnancy@jaeb.org for more information about the study.
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About the Jaeb Center for Health Research
The mission of the Jaeb Center for Health Research in Tampa, Florida is to expand scientific knowledge and improve public health by designing and conducting world-class clinical trials and epidemiologic research. Established in 1993 as a freestanding, nonprofit coordinating center, the Jaeb Center’s focus is on projects involving eye disorders, diabetes, or cystic fibrosis. For more information, please visit www.jaeb.org
About The Leona M. and Harry B. Helmsley Charitable Trust
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has committed more than $4.5 billion for a wide range of charitable purposes. The Helmsley Type 1 Diabetes (T1D) Program is the largest private foundation funder in the world with a focus on T1D, with more than $1 billion to date committed to transform the trajectory of the disease and to accelerate access to 21st century care, everywhere. For more information on Helmsley and its programs, visit helmsleytrust.org.
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Contacts
Jaeb Center for Health Research, T1D Initiative, T1DPregnancy@jaeb.org
Alison Carley, Helmsley Charitable Trust Communications Officer, acarley@helmsleytrust.org