Type 1 Diabetes MellitusFr1daNCT04039945
Fr1da Early Diagnosis and Care of Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Helmholtz Zentrum München at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 285,000 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between the ages of 2 and 10 years
written informed consent by one custodial parent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anette-Gabriele Ziegler, Prof.Dr.med. contact
Germany1 site, 1 recruiting
- Recruiting
Institut für Diabetesforschung, Helmholtz Zentrum München
Munich
Anette-G. Ziegler, Prof.Dr.med.
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Fr1da, Fr1da-Plus, type 1 diabetes, islet autoantibodies
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
presence of multiple islet autoantibodies
multiple islet autoantibodies (IAA, GADA, IA-2A and/or ZnT8A)
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study startFeb 2015
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helmholtz Zentrum München
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Anette-Gabriele Ziegler, Helmholtz Zentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039945
- Sponsor's protocol ID
- 808040014
- Acronym
- Fr1da
- Status last verified
- Dec 2024
- First submitted
- 26 Jul 2019
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 42166139Hippich 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.
PubMed 33163984
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fr1da Early Diagnosis and Care of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04039945
- Acronym / sponsor ID
- Fr1da / 808040014
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Fr1da, Fr1da-Plus, type 1 diabetes, islet autoantibodies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 285,000 participants (estimated)
- Lead sponsor
- Helmholtz Zentrum MünchenIndustry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between the ages of 2 and 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
presence of multiple islet autoantibodies
Time frame: up to 3 years
multiple islet autoantibodies (IAA, GADA, IA-2A and/or ZnT8A)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Derived from this study: PubMed 42166139Winkler 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.
- Derived from this study: PubMed 33163984Hippich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anette-Gabriele Ziegler, Prof.Dr.med. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Helmholtz Zentrum München at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anette-Gabriele Ziegler, Prof.Dr.med. (+49 800-4648835, diabetes.frueherkennung@helmholtz-muenchen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of multiple islet autoantibodies (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04039945, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2024.