Boston Children's Hospital Diabetes Program is participating in the Diabetes Prevention Trial - Type 1 (DPT-1). The DPT-1 is a nationwide clinical trial to determine whether type 1 diabetes, also called insulin-dependent or juvenile diabetes, can be prevented or delayed in people at risk for developing the disease. Preliminary studies conducted in animals have shown that it may be possible to prevent type 1 diabetes with oral insulin or insulin by injection. In one study, mice fed low doses of insulin once or twice a week for 30 weeks were less likely to develop diabetes than mice who were not fed insulin. In animal studies, low doses of insulin by injection have successfully prevented diabetes and, in human studies, insulin injections have preserved the insulin-producing cells in people with prediabetes or in the early stages of diabetes.
If you are interested in participating, or have questions about the clinical trial, please contact Dr. Joseph Wolfsdorf, Director of Children's Diabetes Program.
Who can participate in the trial?
The DPT-1 is screening relatives of people with type 1 Diabetes. People ages 3 to 45 years who have a close relative with the disease are eligible for testing. Close relatives include parents, brothers, sisters, or children. People ages 3 to 20 years who have a distant relative with type 1 diabetes can also be tested. Distant relatives include cousins, nieces, nephews, aunts, uncles, grandchildren or half-brothers or sisters.
Blood tests will reveal those at intermediate and high risk for type 1 diabetes. These individuals will be invited to participate in the study. Children and young adults are encouraged to participate. Children under age 3 may be screened but cannot enroll in the study until they reach the minimum age.
How is the trial designed?
If test results show that a person is at risk for developing diabetes, that person will be invited to participate in the DPT-1 clinical trial. Based on their degree of risk, individuals will be assigned the Oral Insulin Trial. They will be randomly assigned to the oral insulin group or to the placebo control group.
Individuals with a 25 to 50 percent chance of developing IDDM are eligible to participate in the Oral Insulin Trial. They will be randomly assigned to the oral insulin group or to the control group. Volunteers assigned to the oral insulin group will take a daily capsule comprised of insulin crystals.
Both groups will:
- Test blood sugar five times in one day, every 3 months
- Have oral glucose tolerance tests every six months
- Have the benefit of early diagnosis of IDDM well before symptoms appear, enabling initiation of early insulin treatment
DPT-1 volunteers should agree to remain in the study for up to five years. During this time, they will receive free blood tests and other medical care related to the study.
Who is eligible to participate?
To be eligible for the Oral Insulin Trial, individuals must:
- Have a 25 to 50 percent chance of developing IDDM within five years
- Be the parent, sibling, or child of a person with IDDM and between the ages of 3 and 45.
- Be the cousin, nephew, niece, uncle, aunt, grandchild, or half-sibling of a person with IDDM and between the ages of 3 and 20 years old
Researchers will screen children under age 3 for possible future participation in the study.
Who is sponsoring the trial?
The DPT-1 is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in coorperation with the National Institute of Child Health and Human Development, National Institute of Allergy and Infectious Diseases, National Center for Research Resources, Juvenile Diabetes Foundation International and American Diabetes Association.
In addition, promotional support and supplies are also being provided by a number of corporate sponsors including: Eli Lilly and Company, Becton-Dickson and Company, Boehringer Mannheim Corporation, Bristol-Myers Squibb Company, Lifescan Inc., Bayer Inc., and Medisense Inc.