NCT03316261

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
• Phase: —
• Study type: Observational
• Enrollment: 1,000,000 (estimated)
• Sponsor: Helmholtz Zentrum München · Industry
• Sex: All
• Age: 1 Day – 6 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Identification of Infants at Risk for Type 1 Diabetes

Timeline

• Start date: 2017-10-19
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2017-10-20
• Last updated: 2024-12-17

Locations

1 site across 1 country: Germany