Freder1k-Study - Testing Infants for Type 1 Diabetes Risk

Freder1k-Study - Identification of Infants With Increased Type 1 Diabetes Risk for Enrollment Into Primary Prevention Trials

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03316261

Enrollment

1000000

Registered

2017-10-20

Start date

2017-10-19

Completion date

2027-08-31

Last updated

2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Identification of Infants at Risk for Type 1 Diabetes

Keywords

infants, type 1 diabetes, Freder1k

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Days to 6 Weeks

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
greater than 10% risk for multiple beta-cell autoantibodies/type 1 diabetes	one-time testing before age 6 weeks	increased risk will be identified by risk scores derived from SNPs

Countries

Germany

Contacts

Primary ContactAnette-Gabriele Ziegler

contact@gppad.org0800-000 0018

Backup ContactChristiane Winkler

contact@gppad.org0049-89-31873745

Outcome results