Examining how pregnancy factors affect the risk of type 1 diabetes in children
Official title: PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life
Run by University of Colorado, Denver · NCT06141434 · Data updated 2026-11-12
This study is trying to see how different factors during pregnancy might affect the chances of children developing type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 99 Years |
| Sex | All |
| Enrollment | 6000 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 4 sites (Aurora, Colorado and 3 other locations) |
| Status | Recruiting |
| Started | December 1, 2022 |
| Main results expected | November 30, 2032 |
| Study ends | November 30, 2032 |
| Registry record updated | November 21, 2023 |
| Trial ID | NCT06141434 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pregnant women aged 18 or older who have type 1 diabetes or a first-degree relative with the condition.
✕Probably not a fit
Patients with multiple pregnancies or those whose parents do not consent to genetic testing may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the impact of prenatal and obstetric maternal exposures on the risk of type 1 diabetes and islet autoimmunity in children. It focuses on pregnant women who have type 1 diabetes or a first-degree relative with the condition, enrolling both mothers and biological fathers to assess genetic and health contributions. Participants will complete three visits during pregnancy to gather data on various exposures and their potential effects on the child's health. The study aims to recruit a total of 2,000 participants across multiple renowned medical centers.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and prevention strategies for type 1 diabetes in children.
How similar studies have gone: Previous studies have shown success in understanding the genetic and environmental factors influencing type 1 diabetes, making this approach both relevant and promising.
Who can join: the full rules
Show full inclusion / exclusion 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 Criteria: * Parents do not agree to inclusion of the offspring in the study and genetic risk testing * Greater than singleton pregnancy
Where it's running
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University of Colorado
Aurora, Colorado, United States Recruiting -
Joslin Diabetes Center
Boston, Massachusetts, United States Recruiting -
Mt Sinai
New York, New York, United States Recruiting -
Ohio State University
Columbus, Ohio, United States Not yet recruiting
Study contacts
- Principal investigator: JANET K SNELL-BERGEON, PhD, MPH — University of Colorado, Denver
- Study coordinator: JANET K SNELL-BERGEON, PhD, MPH
- Email: Janet.Snell-Bergeon@cuanschutz.edu
- Phone: 7208917122
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Nationwide registry of pregnancies in women with diabetes
This study is trying to gather information about pregnancies in women with diabetes to see how their health and their babies' health are affected, and to find better ways to support them during and after pregnancy.
-
Semaglutide on body composition in adults with type 1 diabetes and overweight/obesity
This study tests whether weekly semaglutide changes body composition in adults with type 1 diabetes who are overweight or obese, compared with a placebo over 24 weeks.
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Next Generation Extended Wear Sensors in Type 1 and Type 2 Diabetes
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This study tests whether teaching mealtime insulin dosing using CGM data helps adults with Type 1 diabetes who don’t usually count carbs.
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Safety and effectiveness of GLP-1 receptor agonists and SGLT inhibitors added to insulin in adults with type 1 diabetes
This registry will see if adding GLP-1RA or SGLTi therapies to insulin helps adults with type 1 diabetes over one year.
-
Think-Find-Solve activities for insulin self-management in children with type 1 diabetes
A behavior-change activity book is tested with children aged 8–12 with type 1 diabetes and their parents to see if it improves daily insulin self-management.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.