Relatives of People with Type 1 Diabetes: From Age 3 to Age 45 - An Oral Insulin Preventative Study
Study Name: Oral Insulin for Prevention of Diabetes in Relatives at Risk for Type 1 Diabetes Mellitus
Study Sponsor: TrialNet
Principal Investigator: Stephen E. Gitelman, M.D.
Who can sign up for this study? To be eligible for this study, you MUST be enrolled in the TrialNet Natural History Study (currently being conducted at UCSF and at other sites). In addition, you MUST:
Have insulin autoantibodies and at least one other type of autoantibody linked to type 1 diabetes. Autoantibody tests are part of the Natural History study.
- Have a normal Oral Glucose Tolerance Test (OGTT). These tests are also part of the Natural History study.
- Have a close relative with type 1 diabetes
- Be 3 to 45 years of age, if your relative with type 1 diabetes is a biological parent, a sibling, or a child
- Be 3 to 20 years of age, if your relative with type 1 diabetes is a cousin, niece, nephew, aunt, uncle, or grandparent
What is this study about? This study is being conducted by the UCSF Pediatric Diabetes Clinical Research Program. The purpose is to see if treatment with oral insulin (capsules of insulin crystals that are taken by mouth) will result in fewer people developing type 1 diabetes compared with people who do not receive oral insulin. Oral insulin is experimental (not approved by the U.S. Food and Drug Administration, or FDA).
What will happen in this study? If you join this study, you will be agreeing to take one study capsule a day and come to UCSF for study visits. For the first year, the visits will be every 3 months. For the rest of the study, the visits will be every 6 months. At the study visits, we will be doing tests, including blood tests to check on your health and diabetes status.
Half of the people in this study will get capsules filled with insulin crystals. The other half will get capsules filled with crystals that are not insulin. You cannot choose which group you will be in. You will be randomly chosen to be in a group. Neither you nor the study team will know which group you are in.
How long will this study last? This study will last approximately 7 to 8 years. It may last a few years longer if needed.
Reimbursement: For your time and effort, you will be paid $50.00 for each completed study visit.
For more information: David Ng at 415-514-3730 or firstname.lastname@example.org.