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NCT02734277
Type 1 Diabetes Extension Study
Conditions: Type 1 Diabetes Mellitus, T1DM, T1D
Sex: All
Ages: 8 Years – 35 Years
Healthy volunteers: No
Enrollment: 111
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Location: UCSF School of Medicine San Francisco California
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 Criteria
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.
Source: ClinicalTrials.gov (NCT02734277). StuddyBuddy aggregates publicly available trial information.