TrialNet: Oral Insulin for Prevention of Type 1 Diabetes in Relatives “At-Risk”

About this Study

Type 1 diabetes is an autoimmune disease. The immune system makes proteins that attack and destroy the cells in the body that produce insulin. These proteins, called autoantibodies, can be found in the blood up to 10 years before someone is diagnosed with diabetes. A major goal of TrialNet studies is to delay or prevent diabetes in people with these antibodies.

TrialNet is now testing oral insulin (insulin taken by mouth, not by injection). We will see if oral insulin helps to delay or prevent type 1 diabetes. Results from a recently completed study (called DPT-1) suggest that oral insulin might delay or prevent type 1 diabetes in some people found to be at risk.

Eligibility Criteria

To be screened, you must fulfill at least one of the two conditions below:

  • 3 to 45 years of age and have a brother, sister, child, or parent with type 1 diabetes
  • 3 to 20 years of age and have a cousin, aunt, uncle, niece, nephew, half sibling, or grandparent with type 1 diabetes

What will I be asked to do?

You will take one study capsule each day.

  • Half of the people will take capsules filled with insulin.
  • Half of the people will take a placebo (capsules that contain an inactive substance).
  • You will not know whether your capsules contain insulin or a placebo.

You will come to a study center for blood tests every 6 months, and at other times as needed.

How to participate

If you have questions about the study or are interested in participating, please contact Gail at ggannon@medicine.bsd.uchicago.edu.