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Early Termination of the Diabetes Control and Complications Trial

In: Data Monitoring in Clinical Trials

Author

Listed:
  • John M. Lachin

    (The George Washington University, The Biostatistics Center)

  • Patricia Cleary

    (The George Washington University, The Biostatistics Center)

  • Oscar Crofford

    (Vanderbilt University, Department of Medicine)

  • Saul Genuth

    (University Hospitals of Cleveland, Case Western Reserve University, Division of Clinical and Molecular Endocrinology, Department of Medicine)

  • David Nathan

    (Harvard University, Department of Medicine)

  • Charles Clark

    (Indiana University, Departments of Medicine, Pharmacology and Toxicology, School of Medicine)

  • Frederick Ferris

    (National Institutes of Health, Division of Epidemiology and Clinical Research, National Eye Institute)

  • Carolyn Siebert

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.

Suggested Citation

  • John M. Lachin & Patricia Cleary & Oscar Crofford & Saul Genuth & David Nathan & Charles Clark & Frederick Ferris & Carolyn Siebert, 2006. "Early Termination of the Diabetes Control and Complications Trial," Springer Books, in: David L. DeMets & Curt D. Furberg & Lawrence M. Friedman (ed.), Data Monitoring in Clinical Trials, chapter 0, pages 93-108, Springer.
    • Handle: RePEc:spr:sprchp:978-0-387-30107-5_9
    DOI: 10.1007/0-387-30107-0_9
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