Type 1 Diabetes Extension Study
Status: Recruiting
Location: See all (12) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 35
Healthy Volunteers: f
View:
• Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
• Ability to sign informed consent/assent (as applicable for children).
Locations
United States
California
UCSF School of Medicine
RECRUITING
San Francisco
Stanford University
RECRUITING
Stanford
Colorado
University of Colorado School of Medicine: Barbara Davis Center for Diabetes
RECRUITING
Aurora
Connecticut
Yale University
COMPLETED
New Haven
Georgia
Emory University
WITHDRAWN
Atlanta
Iowa
University of Iowa Health Care Division of Pediatric Endocrinology
RECRUITING
Iowa City
Indiana
Indiana University Riley Hospital for Children
RECRUITING
Indianapolis
Massachusetts
Joslin Diabetes Center
RECRUITING
Boston
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
South Dakota
Sanford Research
COMPLETED
Sioux Falls
Washington
Benaroya Research Institute
RECRUITING
Seattle
Time Frame
Start Date: 2016-08-18
Estimated Completion Date: 2026-03
Participants
Target number of participants: 111
Treatments
Group 1: Detectable C-peptide by MMTT
Participants with detectable C-peptide at their:~* Last Immune Tolerance Network (ITN) T1DM week 104 study visit,~* Last AbATE (NCT00129259) follow-up visit, or~* Last ITN066AI T1DES visit~Detectable C-peptide is defined as a value above the lower limit of detection.
Group 2:Undetectable C-peptide by MMTT
Participants without detectable C-peptide at their:~* Last ITN T1DM week 104 study visit,~* Last AbATE follow-up visit, or last~* ITN066AI T1DES visit~Undetectable C-peptide is defined as a value below the lower limit of detection.
Related Therapeutic Areas
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: Immune Tolerance Network (ITN)