NCT04039945|Recruiting
Fr1da Early Diagnosis and Care of Type 1 Diabetes
Fr1da
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Fr1da
Sponsor study identifier
observational
285,000
1 country
1
Study Start
February 2015
Actual (reported)Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The Fr1da study: "Early diagnosis and care of type 1 diabetes" aims to carry out a comprehensive, population-based screening for the early diagnosis of type 1 diabetes as part of the U7 to U11 preventive medical check-up for children or between the ages of 2 and 10 years in Bavaria and to implement it in other federal states. Screening is recommended at two time points: 1st screening at the age of 3 years (U7a) and 2nd screening at the age of 7 years (U10). In addition, relatives of patients with type 1 diabetes between the ages of 1 and 21 can be screened repeatedly at intervals of 3 to 5 years for an early-stage of type 1 diabetes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2015
Actual (reported)July 26, 2019
Actual (reported)July 31, 2019
Actual (reported)December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
presence of multiple islet autoantibodies
multiple islet autoantibodies (IAA, GADA, IA-2A and/or ZnT8A)
up to 3 years
Children between the ages of 2 and 10 years
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Institut für Diabetesforschung, Helmholtz Zentrum München
Munich, Germany
Winkler C, Friedl N, Abt R, Ackermann K, Bently J, Braig S, Bramswig S, Dunstheimer D, Ermer U, Ewald D, Gerstl EM, Hammersen J, Haupt F, Hergl M, Hubmann M, Hummel S, Jochem B, Knopff A, Lange K, Lwowsky D, Nellen-Hellmuth N, Prey B, Rettner D, Schill S, Schmidt S, Scholz M, Sindichakis M, Stock J, Stricker D, Volkl TMK, Warncke K, Weber L, Weiss A, Bonifacio E, Achenbach P, Ziegler AG. Screening Children for Early-Stage Type 1 Diabetes. JAMA. 2026 Jun 16;335(23):2046-2056. doi: 10.1001/jama.2026.6085.
Hippich M, Holthaus L, Assfalg R, Zapardiel-Gonzalo J, Kapfelsperger H, Heigermoser M, Haupt F, Ewald DA, Welzhofer TC, Marcus BA, Heck S, Koelln A, Stock J, Voss F, Secchi M, Piemonti L, de la Rosa K, Protzer U, Boehmer M, Achenbach P, Lampasona V, Bonifacio E, Ziegler AG. A Public Health Antibody Screening Indicates a 6-Fold Higher SARS-CoV-2 Exposure Rate than Reported Cases in Children. Med. 2021 Feb 12;2(2):149-163.e4. doi: 10.1016/j.medj.2020.10.003. Epub 2020 Oct 29.
blood samples
Anette-Gabriele Ziegler, Prof.Dr.med.
CONTACT
First Submitted
July 26, 2019
First Posted
July 31, 2019
Study Start
February 2015
Actual (reported)Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 17, 2024
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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