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Early Termination of the Diabetes Control and Complications Trial

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Data Monitoring in Clinical Trials

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Abstract

The Diabetes Control and Complications Trial (1983–1993) of 1,441 subjects followed for an average of 6.5 years assessed the effects of intensive therapy aimed at maintaining near normal levels of blood glucose versus conventional therapy on the risks of diabetes complications of the eyes, kidneys, and nerves. The study was designed to test the hypothesis that the higher than normal blood glucose levels associated with conventional insulin therapy caused these complications. The study was terminated one year ahead of schedule by the monitoring board. This paper describes the medical, ethical, and statistical challenges faced by the study group and the monitoring board.

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Author information

Authors and Affiliations

  1. The Biostatistics Center, The George Washington University, Rockville, Maryland

    John M. Lachin & Patricia Cleary

  2. Department of Medicine, Vanderbilt University, Nashville, Tennessee

    Oscar Crofford

  3. Division of Clinical and Molecular Endocrinology, Department of Medicine, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, Ohio

    Saul Genuth

  4. Department of Medicine, Harvard University, Boston, Massachusetts

    David Nathan

  5. Departments of Medicine, Pharmacology and Toxicology, School of Medicine, Indiana University, Bloomington, Indiana

    Charles Clark

  6. Division of Epidemiology and Clinical Research, National Eye Institute, National Institutes of Health, Bethesda, Maryland

    Frederick Ferris

  7. Scotland, Maryland

    Carolyn Siebert

Authors
  1. John M. Lachin
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  2. Patricia Cleary
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  3. Oscar Crofford
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  4. Saul Genuth
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  5. David Nathan
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  6. Charles Clark
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  7. Frederick Ferris
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  8. Carolyn Siebert
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Editor information

Editors and Affiliations

  1. Department of Biostatistics and Medical Informatics, University of Wisconsin Medical School, Madison, WI, 53972-4675, USA

    David L. DeMets

  2. Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC, 27157, USA

    Curt D. Furberg

  3. Bethesda, MD, USA

    Lawrence M. Friedman

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© 2006 Springer Science+Business Media, Inc.

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Lachin, J.M. et al. (2006). Early Termination of the Diabetes Control and Complications Trial. In: DeMets, D.L., Furberg, C.D., Friedman, L.M. (eds) Data Monitoring in Clinical Trials. Springer, New York, NY. https://doi.org/10.1007/0-387-30107-0_9

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