Identifying infants at risk for type 1 diabetes
Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials
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 |
|---|---|
| Enrollment | 1000000 (estimated) |
| Ages | 1 Day to 6 Weeks |
| Sex | All |
| Sponsor | Helmholtz Zentrum München Industry-sponsored |
| Locations | 1 site (Munich) |
| Trial ID | NCT03316261 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants up to 6 weeks old who have a custodial parent willing to provide informed consent.
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.
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 performed: Other studies have shown promise in identifying genetic markers for type 1 diabetes risk, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: up to age 6 weeks * provided written informed consent by custodial parent Exclusion Criteria: \-
Where this trial is running
Munich
- Institut für Diabetesforschung, Helmholtz Zentrum München — Munich, Germany (Recruiting)
Study contacts
- Study coordinator: Anette-Gabriele Ziegler
- Email: contact@gppad.org
- Phone: 0800-000 0018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.