Fr1da Early Diagnosis and Care of Type 1 Diabetes (Fr1da)

December 12, 2024 updated by: Anette-Gabriele Ziegler, Helmholtz Zentrum München
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

285000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Munich, Germany
        • Recruiting
        • Institut für Diabetesforschung, Helmholtz Zentrum München
        • Contact:
          • Anette-G. Ziegler, Prof.Dr.med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Children between the ages of 2 and 10 years

Description

written informed consent by one custodial parent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of multiple islet autoantibodies
Time Frame: up to 3 years
multiple islet autoantibodies (IAA, GADA, IA-2A and/or ZnT8A)
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helmholtz Zentrum München

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 26, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

July 31, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 808040014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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