Summary

Eligibility
for people ages 8-35 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Stephen Gitelman
Photo 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 select Immune Tolerance Network (ITN) new-onset Type 1 Diabetes Mellitus (T1DM, T1D) interventional studies focusing on immunomodulatory agents. Participants include those that have completed participation in the following trials: ClinicalTrials.gov trials NCT00129259 (AbATE), NCT00965458 (T1DAL) and NCT02293837 (EXTEND) . 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 Prior ITN027AI Study Participants-NCT00129259 Prior ITN045AI Study Participants-NCT00965458 Prior ITN058AI Study Participants-NCT02293837 Diabetes Mellitus Diabetes Mellitus, Type 1

Eligibility

You can join if…

Open to people ages 8-35

  • Prior participation in:
  • NCT00129259 (AbATE)
  • NCT00965458 (T1DAL) or
  • NCT02293837 (EXTEND), and
  • 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
    I am involved in a variety of different translational and clinical research projects, most related to diabetes. A number of the on-going studies are attempts to alter the course of autoimmune-mediated type 1 diabetes, often via immunomodulation, in order to preserve endogenous beta cell function. Some of the recent and on-going projects are described below.

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
Last Updated