Type 1 Diabetes Extension Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8-35
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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 criteria
Qualifiers
Prior participant in an Immune Tolerance Network (ITN) executive committee approved T1DM study.
Ability to sign informed consent/assent (as applicable for children).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
111 Participants
are grouped into 2 trial groupsSponsors and collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Lead sponsor
Immune Tolerance Network (ITN)
Collaborator
Source ClinicalTrials.gov