PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life - The PROMISE Study

Primary Objective

The purpose of this study is to find out more about how health and exposures during pregnancy, such as having an infection, diet and growth may impact later risk of islet autoimmunity in the child. We are also interested in finding out more about why having a father or sibling with type 1 diabetes increases risk of autoimmunity in the child than having a mother with type 1 diabetes.

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The environment during pregnancy may contribute to the risk of islet autoimmunity (IA) in the baby. Having IA increases the risk of type 1 diabetes (T1D) in the child. Illnesses such as viruses could contribute to IA and T1D risk. Pregnancy history may also influence IA and T1D risk. Having a mother with T1D decreases the risk of T1D compared to having a father with T1D. This study plans to study women during their pregnancy to understand how these factors may affect risk of IA in the baby. The goals are to 1) study women during their pregnancy; 2) determine the newborn's genetic risk for developing T1D; 3) follow the baby through early childhood to see if IA develops.

Main Procedures Involved: • Blood collected from mother and questionnaires filled out once per trimester and once after delivery • Screen baby for genetic risk of type 1 diabetes, and have your child followed for measurement of islet autoimmunity, through 5-6 years of age • Father is also asked to complete one visit during pregnancy

Duration of Participation: Up to 6 years for Mother/Child pair.


Child 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

Type of Study



Compensation for time and travel is $25 for each completed maternal, paternal, and child visit.

Principal Investigator
Photograph of Janet Snell-Bergeon,  PhD, MPH/MSPH

Janet Snell-Bergeon, PhD, MPH/MSPH

Study ID

Protocol Number: 22-1840

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