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.
Access provided by Autonomous University of Puebla. Download to read the full chapter text
Chapter PDF
Similar content being viewed by others
Keywords
- Diabetic Retinopathy
- Albumin Excretion Rate
- Case Study Approach
- Complication Trial
- Conventional Insulin Therapy
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.
References
DCCT Research Group. 1993. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329:977–986.
Siebert C, Clark CM. 1993. Operational and policy considerations of data monitoring in clinical trials: The Diabetes Control and Complications Trial Experience. Control Clin Trials 14:30–44.
DCCT Research Group. 1986. The Diabetes Control and Complications Trial (DCCT): Design and methodological considerations for the feasibility phase. Diabetes 35:530–545.
DCCT Research Group. 1988. The Diabetes Control and Complications Trial (DCCT): Update. Diabetes Spectrum 1:187–190.
DCCT Research Group. 1990. The Diabetes Control and Complications Trial (DCCT): Update. Diabetes Care 13:427–433.
DCCT Research Group. 1987. The Diabetes Control and Complications Trial (DCCT): Results of the feasibility study (Phase II). Diabetes Care 10:1–19.
Early Treatment Diabetic Retinopathy Study Research Group. 1991. Grading diabetic retinopathy from stereoscopic color fundus photographs: an extension of the modified Airlie House Classification: ETDRS report No.10. Ophthalmology 98:786–806.
Lachin JM. 2000. Statistical Considerations in the Intent-to-treat Principle. Control Clin Trials 21:167–189.
Lachin JM, Foulkes MA. 1986. Evaluation of sample size and power for analyses of survival with allowance for non-uniform subject entry, losses to follow-up, non-compliance and stratification. Biometrics 42:507–519.
Lan KKG, DeMets DL. 1983. Discrete sequential boundaries for clinical trials. Biometrika 70:659–663.
Lan KKG, DeMets DL. 1989. Group sequential procedures: Calendar versus information time. Stat Med 8:1191–1198.
Wei LJ, Lachin JM. 1984. Two-sample asymptotically distribution-free tests for incomplete multivariate observations. J Am Stat Assoc 79:653–661.
Thall PF, Lachin JM. 1988. Analysis of recurrent events: Nonparametric methods for random interval count data. J Am Stat Assoc 83:339–347.
Lachin JM. 1992. Some large sample size distribution-free estimators and tests for multivariate partially incomplete observations from two populations. Stat Med 11:1151–1170.
Su JQ and Lachin JM. 1992. Group sequential distribution-free methods for the analysis of multivariate observations. Biometrics 48:1033–1042.
Lachin JM. 1988. Statistical properties of randomization in clinical trials. Control Clin Trials 9:289–311.
Wei LJ, Lachin JM. 1988 Properties of the Urn randomization in clinical trials. Control Clin Trials 9:345–364.
Lachin JM. 2000. Biostatistical Methods: The Assessment of Relative Risks. John Wiley and Sons, New York.
Lan KKG, Lachin JM and Bautista OM. 2003. Over-ruling a group sequential boundary-a stopping rule versus a guideline. Stat Med 22:3347–3355.
DCCT Research Group. 1989. Implementation of a multi-component process to obtain informed consent in the Diabetes Control and Complications Trial. Control Clin Trials 10:83–96.
The DCCT/EDIC Research Group. 2000. Retinopathy and nephropathy in patients with type 1 diabetes four years after a trial of intensive therapy. N Engl J Med 342:381–389.
The DCCT/EDIC Research Group. 2002. The effect of intensive therapy on the microvascular complications of type 1 diabetes mellitus. JAMA 287:2563–2569.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2006 Springer Science+Business Media, Inc.
About this chapter
Cite this chapter
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
Download citation
DOI: https://doi.org/10.1007/0-387-30107-0_9
Publisher Name: Springer, New York, NY
Print ISBN: 978-0-387-20330-0
Online ISBN: 978-0-387-30107-5
eBook Packages: Mathematics and StatisticsMathematics and Statistics (R0)