Clinical Study Details

Title

Type 1 Diabetes TrialNet: Oral Insulin Study

Description

A study is being done to see if oral insulin could delay or prevent the onset of type 1 diabetes in individuals identified as being at a greater risk for developing the disease. In a prior study called the Diabetes Prevention Trial, there was evidence that individuals who tested positive at a certain level for a diabetes-related autoantibody called insulin autoantibody (IAA) benefited from the use of oral insulin.
Relatives of people with type 1 diabetes will be screened to determine if they are at risk for developing diabetes. Relatives of people with type 1 diabetes have about a 3-4 percent chance of testing positive for autoantibodies associated with diabetes.

Eligibility

You (or your child) are eligible to be screened to determine your risk of developing type 1 diabetes if you (or your child) are a first degree blood relative (sibling, child, or parent) between the ages of 3 and 45 years or a second degree relative (cousin, uncle, aunt, niece, nephew, grandparent, or half-sibling) between 3 and 20 years of age.
**Note: Your relative that has diabetes probably has type 1 diabetes if they were diagnosed before age 40 AND started on insulin within the first year of diagnosis.**

Procedures

Phase I screening involves a simple blood test for the presence of diabetes related autoantibodies which may appear years before type 1 diabetes develops. If you test positive for the insulin autoantibody and test positive for one or more of the other autoantibodies under investigation, you will be eligible to enter Phase 2 of the Natural History study which would involve having an oral glucose tolerance test, repeat autoantibody testing, and HLA evaluation (HLA is a gene involved in type 1 diabetes).
At the Oral Insulin Initial Visit, participants will have an intravenous glucose tolerance test. Participants will be randomized to receive either oral insulin or placebo daily based on the results of the intravenous glucose tolerance test and autoantibody testing.

Contact

If you are interested in having either you or your child screened for the Natural History Study and potential eligibility for this study, please contact Adriana Soto at (650) 725-6577 or by email at adrianas@stanford.edu to discuss any questions you may have and to schedule a screening appointment.

Please review the consent form, as well as the TrialNet public website, for more information.

Brochure
Consent Form
Assent Form for Ages 7-11
Assent Form for Ages 12-17
Patient Handbook

Spanish Documents:
Consent
Assent - Ages 7-11
Assent - Ages 12-17
Patient Handbook

TrialNet public website at http://www.diabetestrialnet.org