Long-term effects of immunomodulatory treatments in Type 1 Diabetes
Type 1 Diabetes Extension Study
National Institute of Allergy and Infectious Diseases (NIAID) · NCT02734277
This study looks at people with Type 1 Diabetes who have tried certain treatments to see how long they can still make insulin and how their immune system changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 111 (estimated) |
| Ages | 8 Years to 35 Years |
| Sex | All |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) (nih) |
| Locations | 12 sites (San Francisco, California and 11 other locations) |
| Trial ID | NCT02734277 on ClinicalTrials.gov |
What this trial studies
This observational study follows participants who previously took part in selected Type 1 Diabetes Mellitus studies involving immunomodulatory agents. It aims to assess how long these individuals continue to produce insulin and how changes in their immune system over time relate to insulin production. Participants may have follow-up visits ranging from one to five years, which will include health assessments, blood and urine collections, and mixed meal tolerance tests for certain individuals. The findings could inform the development of improved therapies for Type 1 Diabetes in the future.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously participated in an Immune Tolerance Network approved Type 1 Diabetes study.
Not a fit: Patients with medical conditions that could interfere with the trial or those unable to comply with the study schedule may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and therapies for managing Type 1 Diabetes.
How similar studies have performed: Other studies involving immunomodulatory treatments in Type 1 Diabetes have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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). Exclusion Criteria: * 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.
Where this trial is running
San Francisco, California and 11 other locations
- UCSF School of Medicine — San Francisco, California, United States (RECRUITING)
- Stanford University — Stanford, California, United States (RECRUITING)
- University of Colorado School of Medicine: Barbara Davis Center for Diabetes — Aurora, Colorado, United States (RECRUITING)
- Yale University — New Haven, Connecticut, United States (COMPLETED)
- Emory University — Atlanta, Georgia, United States (WITHDRAWN)
- Indiana University Riley Hospital for Children — Indianapolis, Indiana, United States (RECRUITING)
- University of Iowa Health Care Division of Pediatric Endocrinology — Iowa City, Iowa, United States (RECRUITING)
- Joslin Diabetes Center — Boston, Massachusetts, United States (RECRUITING)
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
- Children's Mercy Hospital — Kansas City, Missouri, United States (RECRUITING)
- Sanford Research — Sioux Falls, South Dakota, United States (COMPLETED)
- Benaroya Research Institute — Seattle, Washington, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes Mellitus, T1DM, T1D, Insulin, Glucose Intolerance