111 Participants Needed

Type 1 Diabetes Extension Study

(T1DES Trial)

Recruiting at 8 trial locations
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

LA

Linda A. DiMeglio, MD, MPH,MA

Principal Investigator

Riley Hospital for Children at Indiana University Health

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Evaluation

Participants undergo overall health assessments, blood and urine collections, and MMTTs for certain participants

Up to 5 years
Multiple visits over 5 years

Follow-up

Participants are monitored for safety and effectiveness after evaluation

4 weeks

What Are the Treatments Tested in This Trial?

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Immune Tolerance Network (ITN)

Collaborator

Trials
68
Recruited
7,900+
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