RecruitingNot Applicable

Type 1 Diabetes Extension Study

United States111 participantsStarted 2016-08-18

Plain-language 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.

Who can participate

Age range8 Years – 35 Years

SexALL

See this in plain English?

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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.

What they're measuring

Change in Beta Cell Function by MMTT-Stimulated Mean C-peptide Area Under the Curve (AUC)

Timeframe: Baseline (Visit 0) to Month 60 (Year 5)

Trial details

NCT IDNCT02734277

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2028-08

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials