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The Diabetes Prevention Trial of Type 1 Diabetes (DPT-1)
The Diabetes Prevention Trial of Type 1 (DPT-1) was a multicenter randomized, controlled clinical trial designed to determine whether it is possible to delay or prevent the clinical onset of type 1 diabetes through daily doses of insulin in individuals determined to be at risk for the disease. Subjects were recruited from study clinics and through media campaigns.First-degree relatives, 3 to 45 years of age, and second-degree relatives, 3 to 20 years of age, of patients with diabetes were screened for islet-cell antibodies. Those individuals found to be at high risk of diabetes were randomized to receive either close observation or low-dose parenteral insulin. Those individuals found to be at intermediate risk of diabetes are randomized to receive insulin orally or to receive placebo. Patients were followed for up to six years.
Details
| Lead sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 711 |
| Start date | 1994-02 |
| Completion | 2003-06 |
Conditions
- Diabetes Mellitus, Type 1
Interventions
- Parenteral Insulin
- Close Observation
- Oral Insulin
- Placebo
Primary outcomes
- Rate of Type 1 Diabetes Per Year — Glucose tolerance is measured every 6 months for up to 6 years
The rate of type 1 diabetes per year is calculated by dividing the number of participants who develop diabetes by the total number of years of follow-up. The diagnosis of diabetes is as defined by the American Diabetes Association (ADA) based on oral glucose testing or the presence of symptoms and unequivocal hyperglycemia.
Countries
United States, Canada