NCT03316261

Brief Summary

The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Oct 2017Aug 2027

First Submitted

Initial submission to the registry

October 12, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

October 19, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2017

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

December 17, 2024

Status Verified

December 1, 2024

Enrollment Period

9.8 years

First QC Date

October 12, 2017

Last Update Submit

December 12, 2024

Conditions

Identification of Infants at Risk for Type 1 Diabetes

Keywords

infantstype 1 diabetesFreder1k

Outcome Measures

Primary Outcomes (1)

  • greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes

    increased risk will be identified by risk scores derived from SNPs

    one-time testing before age 6 weeks

Eligibility Criteria

Age1 Day - 6 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

The Freder1k-Study will identify infants who have a high genetic risk of type 1 diabetes.

You may qualify if:

  • Age: up to age 6 weeks
  • provided written informed consent by custodial parent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Diabetesforschung, Helmholtz Zentrum München

Munich, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33163984DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Anette-Gabriele Ziegler

    Helmholtz Zentrum München, IDF-1

    STUDY CHAIR

Central Study Contacts

Anette-Gabriele Ziegler

CONTACT

0800-000 0018contact@gppad.org

Christiane Winkler

CONTACT

0049-89-31873745contact@gppad.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director - Institute of Diabetes Research

Study Record Dates

First Submitted

October 12, 2017

First Posted

October 20, 2017

Study Start

October 19, 2017

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

December 17, 2024

Record last verified: 2024-12

Locations

DE(1)