Long-term effects of immunomodulatory treatments in Type 1 Diabetes
Official title: Type 1 Diabetes Extension Study
Run by National Institute of Allergy and Infectious Diseases (NIAID) · NCT02734277 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 8 Years to 35 Years |
| Sex | All |
| Enrollment | 111 (estimated) |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) NIH |
| Locations | 12 sites (San Francisco, California and 11 other locations) |
| Status | Recruiting |
| Started | June 8, 2016 |
| Main results expected | August 2028 |
| Study ends | August 2028 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT02734277 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who have previously participated in an Immune Tolerance Network approved Type 1 Diabetes study.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies involving immunomodulatory treatments in Type 1 Diabetes have shown promise, suggesting potential for success in this approach.
Who can join: the full rules
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 it's running
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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 -
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
Show 6 more locations
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University of Minnesota
Minneapolis, Minnesota, United States Recruiting -
Benaroya Research Institute
Seattle, Washington, United States Recruiting -
Yale University
New Haven, Connecticut, United States Completed -
Emory University
Atlanta, Georgia, United States Withdrawn -
Children's Mercy Hospital
Kansas City, Missouri, United States Completed -
Sanford Research
Sioux Falls, South Dakota, United States Completed
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Near-sensor insulin delivery with CGM in people with type 1 diabetes
A small early-feasibility study tests a dual-port insulin patch pump that includes a CGM sensor to see if delivering insulin near the sensor affects glucose readings and whether an automated control algorithm can manage glucose.
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Tirzepatide added to an automated insulin delivery system to help adults with type 1 diabetes manage blood sugar
This study tests whether once-weekly tirzepatide can help adults with type 1 diabetes use their insulin pumps more easily, possibly reducing the need to count carbohydrates at meals.
-
CNP-103 treatment for adolescents and young adults recently diagnosed with stage 3 type 1 diabetes
This trial will test whether multiple doses of CNP-103, compared with placebo, help people ages 12–35 who were diagnosed with stage 3 type 1 diabetes within the past 6 months.
-
Investigating the safety and effectiveness of porcine pancreatic cells in patients with Type 1 diabetes
This study is testing if using pig pancreas cells can help adults with tough-to-manage Type 1 diabetes feel better and avoid dangerous low blood sugar episodes.
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Pediatric Insulin Dose Calculator to Help Manage Type 1 Diabetes in Under-12s
A digital tool that helps caregivers of children under 12 with Type 1 diabetes calculate insulin doses during meals, tested alongside standard care for 6 months.
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VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system
This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.