Early diagnosis and care program for type 1 diabetes in children
Fr1da Early Diagnosis and Care of Type 1 Diabetes
Helmholtz Zentrum München · NCT04039945
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 285000 (estimated) |
| Ages | 2 Years to 10 Years |
| Sex | All |
| Sponsor | Helmholtz Zentrum München (industry) |
| Locations | 1 site (Munich) |
| Trial ID | NCT04039945 on ClinicalTrials.gov |
What this trial studies
The Fr1da initiative aims to implement a comprehensive screening program for early diagnosis of type 1 diabetes in children aged 2 to 10 years in Bavaria. The program includes two screening points: at age 3 and again at age 7, with additional screenings for relatives of affected individuals. The study seeks to prevent severe complications such as ketoacidosis, reduce psychological stress for families, and evaluate the prevalence of early-stage diabetes. It also aims to identify geographical and environmental factors influencing the disease's development and progression.
Who should consider this trial
Good fit: Ideal candidates include children aged 2 to 10 years and relatives of individuals with type 1 diabetes aged 1 to 21 years.
Not a fit: Patients outside the specified age range or those without a family history of type 1 diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve early detection and management of type 1 diabetes in children, leading to better health outcomes.
How similar studies have performed: Previous studies have shown success with similar early screening approaches for type 1 diabetes, indicating potential for positive outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
written informed consent by one custodial parent
Where this trial is running
Munich
- Institut für Diabetesforschung, Helmholtz Zentrum München — Munich, Germany (RECRUITING)
Study contacts
- Study coordinator: Anette-Gabriele Ziegler, Prof.Dr.med.
- Email: diabetes.frueherkennung@helmholtz-muenchen.de
- Phone: +49 800-4648835
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.
Conditions: Type 1 Diabetes Mellitus, Fr1da, Fr1da-Plus, type 1 diabetes, islet autoantibodies