Summary

Eligibility
for people ages 8-35 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Stephen Gitelman
Headshot of Stephen Gitelman
Stephen Gitelman

Description

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.

Details

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.

Keywords

Type 1 Diabetes Mellitus, T1DM, T1D, Insulin, Glucose Intolerance, Diabetes Mellitus, Diabetes Mellitus, Type 1, Detectable C-peptide by MMTT

Eligibility

You can join if…

Open to people ages 8-35

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

You CAN'T join if...

  • 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.

Locations

  • UCSF School of Medicine accepting new patients
    San Francisco California 94143 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Lead Scientist at UCSF

  • Stephen Gitelman
    Dr. Gitelman is a physician scientist involved in studies to determine what causes type 1 diabetes mellitus (T1DM), and in clinical trials to prevent disease development, or preserve beta cell function in those recently diagnosed. To this end, he has been an active investigator in the NIH-sponsored TrialNet and Immune Tolerance Network consortia, and other immunotherapy trials in T1DM.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Links
National Institute of Allergy and Infectious Diseases (NIAID) Division of Allergy, Immunology, and Transplantation (DAIT) ITN T1D Extended Study (T1DES) website
ID
NCT02734277
Study Type
Observational
Participants
Expecting 111 study participants
Last Updated