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The Limitations of Clinical Mais for Prevention of IDDM

At least three randomized trials assessing the efficacy of treatments to prevent IDDM in islet-cell antibody (ICA)-positive relatives of persons with the disease are underway. In collaboration with European and American investigators, we have undertaken a trial testing the preventive effect of large daily doses of nicotinamide (the European Nicotinamide Diabetes Intervention Trial [ENDIT]) (1). A second, German study is also evaluating nicotinamide (the Deutsche Nikotinamid Interventionsstudie [DENIS]) (2). In a third American trial (the Diabetes Prevention Trial-Type 1 [DPT-1]), parenteral and oral insulin will be assessed (3). How will these trials affect the care of those at risk for IDDM? We are optimistic that the management of patients with a family history of IDDM will improve if it is shown that the disease's early stages can be safely delayed. In addition, the trials will have a major bearing on the larger goal of preventing IDDM in the general population (4). However, the trials also have limitations that will leave important aspects of the prevention equation unresolved and that will affect the role for IDDM screening as a routine clinical activity. At the same time, strategies are available to reduce such uncertainty, and these strategies would be more effective if considered earlier in the assessment of preventive initiatives. We consider here the limitations of the current prevention trials. We point out that they are unavoidable and that they also apply to future trials, including those testing primary preventions such as vaccines or dietary modification (5). We will then describe three ways to address these limitations that will help clarify the eventual place for routine screening for IDDM.