PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life

We are enrolling women who are pregnant and either have type 1 diabetes or where another first degree relative (father or full sibling) of the baby has type 1 diabetes. Pregnant women will be asked to complete a visit once per trimester (3 visits) during pregnancy and at 4-6 weeks after delivery. The father is also invited to enroll in a single visit. We also plan to screen the baby for genetic risk for type 1 diabetes, using a bloodspot collection at birth. Families will be asked to complete questionnaires about growth health and diet at 6, 12, 18 and 24 months of age and between 5-7 years of age, and to complete blood testing for islet autoantibodies at 24 months and between 5-7 years of age. For those children with a high genetic risk score, we will also collect blood for islet autoantibody testing at 6, 12, and 18 months.
MoreChild to Adult
You may be eligible to participate if you are a pregnant woman who: -Is between 8-24 weeks gestation with a singleton pregnancy -Have type 1 diabetes for at least 12 months, or the father or a full sibling of the baby has type 1 diabetes -Is 18 years of age or older -Is willing to have blood collected and to complete questionnaires about prenatal exposures once per trimester during pregnancy (up to 3 visits) and at 4-6 weeks after delivery -Is willing to have your baby screened for genetic risk for type 1 diabetes, to complete online questionnaires and to have the child followed for measurement of islet autoimmunity according to the determined risk for type 1 diabetes, through 5-7 years of age. o If low risk, two screenings: at 2 years and again between 5-7 years of age o If high risk, five screenings: every 6 months through 2 years, and again at 5-7 years -The father is also asked to complete one visit during the pregnancy, but this is not mandatory Exclusion: • Multiple gestation pregnancy
Observational
Barbara Davis Center
University of Colorado Hospital

Janet Snell-Bergeon, PhD, MPH/MSPH
Protocol Number: 22-1840
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