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TRIALNET recruitment

NIH NEWS RELEASE Oral Insulin Does Not Prevent Type 1 Diabetes

NIH NEWS RELEASE Insulin Injections Fail To Prevent Type 1 Diabetes

Type 1 Diabetes Prevention Trials - QUESTIONS & ANSWERS




NIH Website
Welcome to Diabetes Prevention
Trial - Type 1 (DPT-1)
NIDDK Website

The Diabetes Prevention Trial of Type 1 Diabetes is the combination of two studies envisioned to be the first in a series of studies designed to test the potential to prevent or delay the onset of Type 1 diabetes mellitus (DM). Individuals can be placed into one of four risk groups for type 1 DM based upon the presence or absence of various immunological markers as well as tests of insulin secretion. Individuals can be found to be at "High Risk", "Intermediate Risk", "Modest Risk", or "Low Risk". The purpose of dividing individuals into these four predictive risk groups is that specific intervention strategies are best applied to them because of their stage in natural history, while the invasiveness of the therapeutic approaches to be tested needs to be appropriately reconciled with the estimated risk of Type 1 DM in the different risk groups. For more information about DPT-1, visit the Questions & Answers section.

The intervention protocol for the "Intermediate Risk" group was designed to determine whether presentation of an islet cell autoantigen (i.e. orally ingested insulin) to the immune system via the intestinal mucosa could induce disease relevant immunological tolerance, thereby delaying the development of Type 1 DM. This study, which is now completed, was designed to be a randomized, placebo-controlled, double-blind, multicenter clinical trial. You can find out the results of this trial in NIH's News Release.

The protocol for the "High Risk" group was designed to determine whether parenteral insulin therapy, consisting of periodic courses of continuous intravenous insulin, with accompanying chronic subcutaneous insulin, will delay their expected development of clinical Type 1 DM. This now completed trial was a randomized, controlled, multicenter clinical trial. You can find out the results of this trial in NIH's News Release.