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Clinical Trial Summary

This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D). This observational study will: - follow participants to determine how long they continue to produce insulin, and - will also assess how changes in the immune system over time relate to the ability to produce insulin. This information could help design better therapies for type 1 diabetes in the future.


Clinical Trial Description

Depending upon a participant's level of insulin production, participation may be as short as one return visit or a maximum of five years. Evaluation visits will include: - Overall health assessments - Blood and urine collections - Mixed meal tolerance test (MMTTs) for certain participants, per protocol. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02734277
Study type Observational
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Recruiting
Phase
Start date August 18, 2016
Completion date March 2025

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