No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
0 Days – 99
Sex
Any
Study type
Observational
Participants needed
6,000 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for pregnant women who have type 1 diabetes or have a child with a first-degree relative that has type 1 diabetes. Participants will have a few visits during and after pregnancy to share health information and provide blood samples.
Are You a Good Fit for This Trial?
You may be able to join if
I am pregnant and at least 18 years old.
I am the biological and gestational mother.
I am up to 24 weeks pregnant when I join.
My child has a first-degree relative with type 1 diabetes.
You may not be able to join if
I do not agree to include my child in the study.
I am having more than one baby (multiple pregnancy).
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This research study is called 'PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life: The PROMISE Study'. The purpose of this study is to find out more about how exposures during pregnancy, such as having an infection, diet and growth may impact later risk of type 1 diabetes (TID) and islet autoimmunity in the child. We are also interested in finding out more about why h…
This research study is called 'PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life: The PROMISE Study'. The purpose of this study is to find out more about how exposures during pregnancy, such as having an infection, diet and growth may impact later risk of type 1 diabetes (TID) and islet autoimmunity in the child. We are also interested in finding out more about why having a father or sibling with T1D increases risk of autoimmunity in the child more than having a mother with T1D.
We are enrolling women who are pregnant and either have T1D or another first degree relative (father or full sibling) of the baby has T1D. The biological father is also invited to enroll in study, as it is important to understand how the father's health and genetics may contribute to the child's risk of developing T1D. The study procedures for the mother, father and baby are explained below.
Mother: Pregnant women will be asked to complete a visit once per trimester (3 visits) during pregnancy and one visit up to 12 weeks after delivery. At each visit, mothers will consent to a blood draw, collection of biological samples and the completion of questionnaires. . Mothers who have T1D will also be asked to download any diabetes device data they have, such as continuous glucose monitor or insulin pump data.
Father: The (biological) father will be invited to enroll in a single visit. He will consent to a blood draw and completion of questionnaires. Fathers with T1D will also be asked to download any diabetes device data they have, such as continuous glucose monitor or insulin pump data.
Baby: The baby will have blood collected at birth to determine the genetic risk for T1D. Families will consent to the completion of 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 autoantibody testing at 6, 12, and 18 months of age.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Pregnant women and their offspring where the offspring has a first degree relative (mother, biological father, full sibling) with type 1 diabetes
* Mother is 18 or older
* Mother is both gestational and biological mother
* Gestation up to 24 weeks at enrollment
Exclusion Crit…
Inclusion Criteria:
* Pregnant women and their offspring where the offspring has a first degree relative (mother, biological father, full sibling) with type 1 diabetes
* Mother is 18 or older
* Mother is both gestational and biological mother
* Gestation up to 24 weeks at enrollment
Exclusion Criteria:
* Parents do not agree to inclusion of the offspring in the study and genetic risk testing
* Greater than singleton pregnancy
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