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Type 1 Diabetes Extension Study

RECRUITINGSponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Actively Recruiting
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Started2016-08-18
Est. completion2026-03
Eligibility
Age8 Years – 35 Years
Healthy vol.Accepted
Locations12 sites

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.

Eligibility

Age: 8 Years – 35 YearsHealthy volunteers accepted
Inclusion Criteria:

* Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
* Ability to sign informed consent/assent (as applicable for children).

Exclusion Criteria:

* Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial; or
* Inability to comply with the study visit schedule and required assessments.

Conditions4

DiabetesT1DT1DMType 1 Diabetes Mellitus

Locations12 sites

UCSF School of Medicine
San Francisco, California, 94143
Rebecca Wesch415-476-5984rebecca.wesch@ucsf.edu
Stanford University
Stanford, California, 94305
Trudy Esrey650-498-4450tesrey@stanford.edu
University of Colorado School of Medicine: Barbara Davis Center for Diabetes
Aurora, Colorado, 80045
Mara Kinney303-724-8272MARA.KINNEY@ucdenver.edu
Yale University
New Haven, Connecticut, 06519
Emory University
Atlanta, Georgia, 30322

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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