TrialNet - Family Screening Study for Type 1 Diabetes

Screening and the Natural History Study of the Development of Type 1 Diabetes

Protocol Description

The primary purpose of this 3-part TrialNet study is to learn more about how Type 1 diabetes (T1D) occurs and will be done via screening close blood relatives of people with T1D. The presence of diabetes-related autoantibodies will be determined through blood draws, which can signify the cells in the pancreas that produce insulin are damaged. A positive result will lead to participation in the additional phases. The second and third phases will be used to follow the participant throughout the study to see if there are changes or if the participant develops diabetes. Those at risk of T1D may qualify for other TrialNet studies to prevent diabetes. About 200,000 participants will be screened for this study, with participants coming from locations both internationally and from Children’s Hospital of Pittsburgh of UPMC.

Eligibility Criteria

Eligible participants encompass males and females age 1 to 45 years who have an immediate or extended blood relative with T1D, but have not themselves been diagnosed with diabetes.
Males: age 1 to 45
Females: age 1 to 45


Children will have a yearly blood sample until the age of 18. Adults will have a single blood sample. In addition about 5 percent of subjects will qualify for an oral glucose tolerance test in Phase 2 and Phase 3 to determine changes or if the participant has developed diabetes. Participants should plan on clinic visits once or once a year during the first phase of the study and every 6 months during phase 2 and 3.
Visits: Determined by age of participant
Duration: Open ended

Status: Open for Enrollment

Source(s) of Support

National Institutes of Health
Juvenile Diabetes Research Foundation
American Diabetes Association

Primary Investigator

Dorothy J. Becker, MBBCh

Contact Information

To get started, please contact:
Karen RIley, RN, BSN