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Type 1 Diabetes Extension Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
8 Years to 35 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Depending upon a participant's level of insulin production, participation may be as short as one return visit or a maximum of five years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows people who took part in certain Immune Tolerance Network (ITN) studies for newly diagnosed type 1 diabetes. Those earlier studies used drugs that change how the immune system works. This study does not test a new treatment; it tracks how long people keep making insulin and how immune system changes relate to this.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You took part in a type 1 diabetes study approved by the ITN executive committee.
  • You can sign a form agreeing to join the study, including a child agreement form when needed.

Who can't join

  • You have a health condition that the lead study doctor believes would make it unsafe for you to finish the study.
  • You cannot follow the study visit schedule or complete the required tests and checks.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (12)

CA

CO

CT

GA

IA

IN

MA

MN

MO

SD

WA