Identification of Infants at Risk for Type 1 DiabetesNCT03316261
Freder1k-Study - Testing Infants for Type 1 Diabetes Risk
An observational study of Identification of Infants at Risk for Type 1 Diabetes, run by Helmholtz Zentrum München at 1 site in Germany.
Trial summary
The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes. Read more about this study
- Who is it for?
- Ages 1 day to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Identification of Infants at Risk for Type 1 Diabetes
- How many people
- 1,000,000 participants
- Where
- 1 siteGermany
- Study dates
- 19 Oct 2017to Aug 2027
- 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 1 day to 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.
Who may be able to join
- Age: up to age 6 weeks
- provided written informed consent by custodial parent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Institut für Diabetesforschung, Helmholtz Zentrum München
Munich
Anette-G. Ziegler, Prof. Dr.
About this study
Official title: Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials
The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.
Read the detailed description
Type 1 diabetes is a common chronic disease in childhood and is increasing in incidence. Type 1 diabetes is diagnosed by hyperglycemia often in combination with symptoms of weight loss, thirst, fatigue and frequent urination, sometimes with ketoacidosis. The clinical onset is preceded by an asymptomatic phase identified by serum multiple beta-cell autoantibodies. Neonates and infants who are at increased risk to develop multiple beta-cell autoantibodies and type 1 diabetes can now be identified using genetic markers. This provides opportunity for introducing early therapies to prevent beta-cell autoimmunity and type 1 diabetes.
- Keywords
- infants, type 1 diabetes, Freder1k
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes
increased risk will be identified by risk scores derived from SNPs
Measured: one-time testing before age 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start19 Oct 2017
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Identification of Infants at Risk for Type 1 DiabetesStudies 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
- Cross-sectional
- Enrolment
- 1,000,000 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
- Investigators
- Anette-Gabriele Ziegler, Study chair, Helmholtz Zentrum München, IDF-1
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316261
- Sponsor's protocol ID
- GPPAD-02
- Status last verified
- Dec 2024
- First submitted
- 12 Oct 2017
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
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
- Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials
- ClinicalTrials.gov ID
- NCT03316261
- Acronym / sponsor ID
- GPPAD-02
- Keywords
- infants, type 1 diabetes, Freder1k
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000,000 participants (estimated)
- Lead sponsor
- Helmholtz Zentrum MünchenIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2017 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Oct 2017 (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 Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.
Detailed description
Type 1 diabetes is a common chronic disease in childhood and is increasing in incidence. Type 1 diabetes is diagnosed by hyperglycemia often in combination with symptoms of weight loss, thirst, fatigue and frequent urination, sometimes with ketoacidosis. The clinical onset is preceded by an asymptomatic phase identified by serum multiple beta-cell autoantibodies. Neonates and infants who are at increased risk to develop multiple beta-cell autoantibodies and type 1 diabetes can now be identified using genetic markers. This provides opportunity for introducing early therapies to prevent beta-cell autoimmunity and type 1 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.
Key inclusion criteria (2 listed)
- Age: up to age 6 weeks
- provided written informed consent by custodial parent
Key exclusion criteria (1 listed)
- -
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
greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes
Time frame: one-time testing before age 6 weeks
increased risk will be identified by risk scores derived from SNPs
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 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.
- GPPADLink provided by the sponsor.
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 study chair
Helmholtz Zentrum München, IDF-1
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 Identification of Infants at Risk for Type 1 Diabetes, 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 (0800-000 0018, contact@gppad.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes (time frame: one-time testing before age 6 weeks). 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 NCT03316261, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 28 Oct 2026.