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Information for Study Participants

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

Status: Recruiting

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

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.

If someone in your family has type 1 diabetes, you and other family members may be at risk. TrialNet is working to delay or prevent diabetes in people at risk for developing type 1 diabetes.

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.

If you have antibodies but cannot or do not want to be in the Oral Insulin Study, you can be in the TrialNet Pathway to Prevention Study. We will monitor you closely for diabetes. In addition, there may be other TrialNet studies that you can join in the future.

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.

Participation

To see if you might be eligible for this study and for a referral to a TrialNet site:

The blood test to determine whether or not you are at risk for type 1 diabetes is part of the Pathway to Prevention Study. Please see the list of Clinical Centers for more information.

Information will be kept confidential.

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