Observational Study for Type 1 Diabetes

(T1DES Trial)

Recruiting at 8 trial locations

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Disqualifiers: Medical condition, Non-compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

111 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine the long-term effects of treatments used in earlier type 1 diabetes studies. Researchers seek to determine how long participants continue to produce insulin and how their immune systems change over time. This research could lead to improved therapies for managing type 1 diabetes in the future. Eligible participants must have been part of a previous study on new type 1 diabetes treatments and be able to attend all study visits.

As an unphased trial, this study provides a unique opportunity to enhance the understanding of long-term treatment effects, potentially benefiting future patients with type 1 diabetes.

Why are researchers excited about this trial?

Most treatments for Type 1 Diabetes depend on insulin replacement, which involves regular injections or a pump to manage blood sugar levels. However, researchers are excited about the new treatment under study because it has the potential to modify the immune system to protect pancreatic beta cells. Unlike standard insulin therapy that only manages symptoms, this treatment aims to address the underlying autoimmune process of Type 1 Diabetes. This could mean fewer insulin doses and better long-term management of the disease.

Who Is on the Research Team?

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?

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+