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Fr1da Early Diagnosis and Care of Type 1 Diabetes

Fr1da Early Diagnosis and Care of Type 1 Diabetes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04039945
Acronym
Fr1da
Enrollment
285000
Registered
2019-07-31
Start date
2015-02-28
Completion date
2028-12-31
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Fr1da, Fr1da-Plus, type 1 diabetes, islet autoantibodies

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.

Detailed description

With the Fr1da study, 100,000 children in the Free State of Bavaria were offered a one-off screening for the early diagnosis of type 1 diabetes from January 1, 2015 to 2019 as part of the U7 (21st month of life) to U9 (64th month of life) check-ups, or as part of any other visit at the paediatrician between the ages of 2 and 5. After 100,000 children had been screened in the Fr1da study, the screening was continued as part of Fr1da (formerly Fr1da-Plus). The screening was then extended to a second age group from 6 to 10 years (U10-U11). As relatives of people with type 1 diabetes have an up to 10-fold increased risk of developing type 1 diabetes themselves, the screening is also offered to these people between the age 1 to 21 years. The aim of the Fr1da study is 1) to prevent life-threatening ketoacidosis at clinical manifestation of type 1 diabetes, 2) to reduce anxiety, uncertainty and psychological stress through training and intensive support for those affected, 3) to test the feasibility of two-time nationwide screening and evaluate the benefits, 4) to determine the prevalence of early-stage type 1 diabetes in children in defined age groups and in first and second screening, 5) to identify geographical differences and associations with environmental factors in the development and progression of the disease and 6) to prevent disease progression by means of preventive therapies. From 2024, the screening will also be offered in other federal states outside of Bavaria.

Interventions

None listed

Sponsors

Helmholtz Zentrum München
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes

Inclusion criteria

written informed consent by one custodial parent

Design outcomes

Primary

MeasureTime frameDescription
presence of multiple islet autoantibodiesup to 3 yearsmultiple islet autoantibodies (IAA, GADA, IA-2A and/or ZnT8A)

Countries

Germany

Contacts

Primary ContactAnette-Gabriele Ziegler, Prof.Dr.med.
diabetes.frueherkennung@helmholtz-muenchen.de+49 800-4648835

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 22, 2026