The findings of two studies appearing in The New England Journal of Medicine (NEJM) on May 30 bring researchers a step closer to the goals of preventing type 1 diabetes and of preserving insulin production in people newly diagnosed with the disease. The studies, though different in size, goals, design, and outcomes, illustrate the therapeutic potential of an improved understanding of the autoimmune process that leads to type 1 diabetes.

One study--a large, multicenter, controlled clinical trial in 339 people at high risk (50 percent or greater chance) of developing type 1 diabetes in 5 years--found that low-dose insulin injections do not delay or prevent type 1 diabetes. The finding clearly negated earlier animal studies and a small pilot study in people, both of which suggested that insulin injections could prevent type 1 diabetes. Some physicians, relying on these preliminary studies, had begun using insulin injections to prevent diabetes in their at-risk patients.

"This trial showed the importance of conducting well-designed, carefully controlled clinical trials to definitively answer questions about the value of specific prevention approaches," said study chair Dr. Jay S. Skyler of the University of Miami. "We've learned that insulin injections, given in the way tested in this trial and in people at high risk of developing type 1 diabetes, do not delay or prevent type 1 diabetes. But from this study we've also learned a great deal about how type 1 diabetes develops and proven that immune and metabolic markers can be used to quantify the risk of diabetes. This knowledge is already proving extremely valuable for prevention efforts that will be tested in upcoming clinical trials."

The findings of the low-dose insulin injection trial, one of two trials that make up the Diabetes Prevention Trials-Type 1 (DPT-1), have laid the groundwork for other prevention studies by yielding a great deal of useful information about the antibody mark
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Contact: Joan Chamberlain
301-496-3583
NIH/National Institute of Diabetes and Digestive and Kidney Diseases
29-May-2002

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