Freder1k-Study - Testing Infants for Type 1 Diabetes Risk

Recruiting

• Conditions: Identification of Infants at Risk for Type 1 Diabetes

• Registration Number: NCT03316261
• Lead Sponsor: Helmholtz Zentrum München

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.

Study Timeline

• Study First Submitted: 2017-10-12
• Study Start: 2017-10-19
• Study First Submitted QC: 2017-10-19
• Study First Posted: 2017-10-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000000

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut für Diabetesforschung, Helmholtz Zentrum München; 🇩🇪 Munich, Germany