Fr1da-/Fr1da-Plus-Study in Bavaria: Early Detection for Early Care of Type 1 Diabetes (Fr1da-Plus)

September 21, 2023 updated by: Anette-Gabriele Ziegler, Helmholtz Zentrum München
The Fr1da study aims to assess whether early staging of type 1 diabetes (1) is feasible at a population-based level, (2) prevents severe metabolic decompensation observed at the clinical manifestation of type 1 diabetes and (3) reduces psychological distress through preventive teaching and care.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Type 1 diabetes can be diagnosed at an early presymptomatic stage by the detection of islet autoantibodies. Within the Fr1da-study, 100 000 children aged 1.75-5.99 years are tested for the presence of multiple islet autoantibodies. Screening is performed by primary care paediatricians. Islet autoantibodies are measured in capillary blood, and if positive, confirmed by venous blood in a second follow-up blood sample. Children with confirmed multiple islet autoantibodies are diagnosed with presymptomatic type 1 diabetes. These children and their parents are invited to participate in an education and counselling programme at a local diabetes centre. Depression and anxiety, and burden of early diagnosis are also assessed. The Fr1da-Plus-Study starts in 2019, after the enrollment of 100000 children into Fr1da, and extends screening to ages 9.0-10.99 years, and follows children with single islet autoantibodies for up to 3 years for progression to multiple islet autoantibody positivity.

The aims of the Fr1da- and Fr1da-Plus studies are:

  • to prevent life-threatening diabetic ketoacidosis at clinical onset of diabetes
  • to minimize psychological burden and uncertainty by training and intensive support of affected subjects
  • to evaluate feasibility of a comprehensive screening
  • to examine the prevalence of a pre-stage of Type 1 Diabetes
  • to assess geographic differences and association with environmental conditions for development of Type 1 Diabetes

The predefined criteria for the feasibility and clinical benefit of the study are >80% participation in the education and staging program, a diabetic ketoacidosis frequency of <5% in children with stage 3 diabetes, and <10% of parents with a Patient Health Questionnaire-9 (PHQ-9) sum score >15.

Study Type

Observational

Enrollment (Estimated)

180000

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 living in Bavaria at ages 1.75-5.99 years (U7 - U9) (Fr1da-study) and/or 9.0-10.99 years (U11)(Fr1da-Plus-Study)

Description

children living in Bavaria with 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)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

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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