Pathway to Prevention
TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes.
Study phase: Other
Study phase (if other): Observational
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Inclusion Criteria:
- Individuals 2 to 45 years old who have an immediate family member with type 1 diabetes (such as a child, parent, or sibling)
- Individuals 2 to 20 years old who have an extended family member with type 1 diabetes (such as a grandparent, half-sibling, cousin, niece, nephew, aunt, or uncle)
- Individuals 2 to 45 years old who are not family members of an individual with type 1 diabetes and are known to have 1 or more islet antibodies. These individuals are eligible for screening.
Exclusion Criteria:
To be eligible a person must not:
- Have diabetes already.
- Have previous or current history of being treated with insulin or oral diabetes medications.
- Currently using systemic immunosuppressive or immunomodulatory therapies, including pharmacologic doses of systemic steroids (may include topical and inhaled agents).
- Have any known serious diseases and/or diseases that are likely to limit life expectancy or lead to use of chronic immunocompromise or immunomodulatory therapies during the use of the study.
Primary disease category: Diabetes & Endocrine System
Secondary disease categories: Children, Infants & Newborns
This study is enrolling healthy volunteers.
Sponsor: TrialNet
Protocol number: STUDY0900000158
Projected enrollment dates: April 2021 to July 2025
Official study title: TrialNet Pathway to Prevention of T1D
External link(s):
https://www.trialnet.org/
ClinicalTrials.gov page:
http://www.clinicaltrials.gov/show/NCT00097292