NCT04039945

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
285,000

participants targeted

Target at P75+ for all trials

Timeline
31mo left

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Feb 2015Dec 2028

Study Start

First participant enrolled

February 1, 2015

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2019

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

13.8 years

First QC Date

July 26, 2019

Last Update Submit

December 12, 2024

Conditions

Keywords

Fr1daFr1da-Plustype 1 diabetesislet autoantibodies

Outcome Measures

Primary Outcomes (1)

  • presence of multiple islet autoantibodies

    multiple islet autoantibodies (IAA, GADA, IA-2A and/or ZnT8A)

    up to 3 years

Eligibility Criteria

Age2 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children between the ages of 2 and 10 years

written informed consent by one custodial parent

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Institut für Diabetesforschung, Helmholtz Zentrum München

Munich, Germany

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Anette-Gabriele Ziegler, Prof.Dr.med.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.med. Anette-G. Ziegler, Director, Institute of Diabetes Research

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 31, 2019

Study Start

February 1, 2015

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations