Identifying infants at risk for type 1 diabetes
Official title: Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials
Run by Helmholtz Zentrum München · NCT03316261 · Data updated 2026-11-12
This study is trying to find babies who are at high risk for type 1 diabetes by looking for certain markers in their blood, so that doctors can help prevent the disease before it starts.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day to 6 Weeks |
| Sex | All |
| Enrollment | 1000000 (estimated) |
| Sponsor | Helmholtz Zentrum München Industry-sponsored |
| Locations | 1 site (Munich) |
| Status | Recruiting |
| Started | October 19, 2017 |
| Main results expected | August 2027 |
| Study ends | August 2027 |
| Registry record updated | December 17, 2024 |
| Trial ID | NCT03316261 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants up to 6 weeks old who have a custodial parent willing to provide informed consent.
✕Probably not a fit
Patients who are older than 6 weeks or do not have a custodial parent available to provide consent 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
The Freder1k-Study aims to identify infants who are at high genetic risk for developing type 1 diabetes. This observational study focuses on detecting multiple beta-cell autoantibodies in neonates and infants, which can indicate an increased likelihood of developing the disease. By utilizing genetic markers, the study seeks to identify those at risk early, potentially allowing for the introduction of preventive therapies before the onset of symptoms. The study is crucial as type 1 diabetes is becoming more common in childhood.
Why it matters
Potential benefit: If successful, this study could lead to early interventions that may prevent the onset of type 1 diabetes in at-risk infants.
How similar studies have gone: Other studies have shown promise in identifying genetic markers for type 1 diabetes risk, suggesting that this approach may be effective.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: up to age 6 weeks * provided written informed consent by custodial parent Exclusion Criteria: \-
Where it's running
-
Institut für Diabetesforschung, Helmholtz Zentrum München
Munich, Germany Recruiting
Study contacts
- Study coordinator: Anette-Gabriele Ziegler
- Email: contact@gppad.org
- Phone: 0800-000 0018
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Early diagnosis and care program for type 1 diabetes in children
This study is testing a new screening program to help find type 1 diabetes early in children aged 2 to 10 in Bavaria to prevent serious health issues and support families better.
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.