TrialNet - Prevention of Type 1 Diabetes

Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus

Protocol Description

The TrialNet Oral Insulin Diabetes Prevention Study seeks to determine whether repeated intervention with oral insulin prevents or delays the development of Type 1 Diabetes Mellitus (T1DM) in non-diabetic relatives of patients with T1DM. Eligible relatives for the study are those who have antibodies to the body’s own insulin and do not have any blood sugar abnormalities. Results from previous tests suggest that oral insulin may delay diabetes in people with higher levels of insulin autoantibodies. This new multi-center study seeks to determine if these findings are true in similar groups of people.

Eligibility Criteria

Eligible participants include children and adults, who do not have diabetes of any kind, have participated in the TrialNet Natural History study and have had tests that show they have normal glucose levels, but have certain markers associated with an increased risk of developing T1DM. Candidates should be age 3 to 45, and have a sibling or parent with T1DM; or age 3 to 20, and have a cousin, aunt, uncle, niece, nephew, half-sibling or grandparent with T1DM.
Males: age 3 to 45
Females: age 3 to 45


Following an initial screening visit, there will be a 3-month visit, and thereafter participants will have clinic visits every 6 months throughout the length of this study. At each visit, a physical, blood tests and other health measurements will be done.
Visits: Number of visits dependent on whether participant develops T1DM Type 1 diabetes and duration of the study
Duration: Ongoing through 2014

Status: Open for Enrollment

Primary Investigator

Dorothy J. Becker, MBBCh

Contact Information

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