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Type 1 Diabetes Extension Study (T1DES)

  • Study HIC#:1512016925
  • Last Updated:07/15/2021

To further our understanding of the immunologic mechanisms underlying maintenance and loss of beta cell function by evaluating the relationship between longitudinal changes in beta cell function and changes over time in biomarkers known to be associated with a response to immune modulating treatments which were used in prior clinical trials (Refer to ClinicalTrials.gov records NCT00129259 and NCT00965458).

  • Age8 years - 35 years
  • GenderBoth
  • Start Date05/06/2016
  • End Date03/01/2021

Trial Purpose and Description

Multicenter prospective follow-up study of the long term effects of participation in selected completed ITN new-onset TID studies with immunomodulatory agents

Eligibility Criteria

Inclusion Criteria:

  • Prior participation in protocol ITN027AI AbATE(NCT00129259) or protocol ITN045AI T1DAL(NCT00965458) studies
  • 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.
  • Inability to comply with the study visit schedule and required assessments

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