Study of Pregnancy and Family History Effects on Type 1 Diabetes Risk and Autoantibodies in Early Childhood

What this Trial Is About

Researchers are studying how exposures during pregnancy, such as infections, diet, and growth, may affect a childs risk of developing type 1 diabetes T1D and islet autoimmunity. This study focuses on families where the baby has a first degree relative with T1D, including mothers, fathers, or siblings, and aims to understand why risk varies depending on which family member has T1D. The study is observational and involves multiple research centers in the United States. Pregnant women with T1D or whose baby has a father or sibling with T1D are enrolled along with the biological fathers. Mothers have visits once per trimester and up to 12 weeks after delivery, with blood draws, biological sample collections, and questionnaires. Fathers have a single visit with blood collection and questionnaires. Babies have blood collected at birth for genetic risk testing and are followed with questionnaires and blood tests for autoantibodies at several ages up to 7 years. Participants provide medical records, complete questionnaires on health, diet, and diabetes management, and provide biological samples including blood, vaginal swabs, stool, and cord blood. The study measures islet autoantibody development in children up to six years old and monitors glycemic control in mothers with T1D. Families receive education on T1D signs and symptoms and may access support programs. The study follows children at high genetic risk more closely with additional blood testing and questionnaires.

PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life