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Received on August 26, 2004
Accepted on January 6, 2005
General Clinical Chemistry |
1 Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis MN
2 Biostatistics Center, the George Washington University, Rockville MD
3 Departments of Pathology and Anatomical Sciences and Child Health, University of Missouri, Columbia, MO
4 Fairview University Medical Center, Minneapolis MN
* To whom correspondence should be addressed. E-mail: steff001{at}umn.edu.
Background: Clinical trials require assays that provide consistent results during the course of a study. The hemoglobin A1c (HbA1c) assay, a measure of chronic glycemia, is critical to the study of diabetes control and complications.
Methods: The Diabetes Control and Complications Trial (DCCT) and its follow-up study, the Epidemiology of Diabetes Interventions and Complications (EDIC), required 20 years of consistent HbA1c results, measured by three different ion-exchange HPLC procedures. To maintain and document consistent HbA1c results measured in the DCCT and EDIC Central Biochemistry Laboratory, a backup laboratory used frozen hemolysates as long-term calibrators and a HPLC method with a single lot of Bio-Rex 70 resin.
Results: Over 20 years, long-term quality-control values have remained constant. Four studies of nondiabetic ranges produced nearly identical values [mean (SD), 5.1 (0.5)%, 4.9 (0.3)%, 5.0 (0.4)%, and 5.0 (0.3)%].
Conclusions: The overall consistency of the HbA1c assays during the 20-year course of the DCCT and EDIC has been critical in establishing the benefits of intensive therapy and in understanding the relationship between long-term glycemia and the development and progression of the complications of diabetes.
The following articles in journals at HighWire Press have cited this article:
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  S.-C. Shiesh, H.-M. Wiedmeyer, J.-T. Kao, S. D. Vasikaran, J. B. Lopez, and the Laboratory Management Committee for the Asian- Proficiency Testing of Hb A1c: A 4-Year Experience in Taiwan and the Asian Pacific Region Clin. Chem., October 1, 2009; 55(10): 1876 - 1880. [Abstract] [Full Text] [PDF]
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 Diabetes Control and Complications Trial/Epidemiol Modern-Day Clinical Course of Type 1 Diabetes Mellitus After 30 Years' Duration: The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications and Pittsburgh Epidemiology of Diabetes Complications Experience (1983-2005) Arch Intern Med, July 27, 2009; 169(14): 1307 - 1316. [Abstract] [Full Text] [PDF]
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 P. Enzlin, R. Rosen, M. Wiegel, J. Brown, H. Wessells, P. Gatcomb, B. Rutledge, K.-L. Chan, P. A. Cleary, and the DCCT/EDIC Research Group Sexual Dysfunction in Women With Type 1 Diabetes: Long-term findings from the DCCT/ EDIC study cohort Diabetes Care, May 1, 2009; 32(5): 780 - 785. [Abstract] [Full Text] [PDF]
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S. K. Van Den Eeden, A. V. Sarma, B. N. Rutledge, P. A. Cleary, J. W. Kusek, L. M. Nyberg, K. T. McVary, H. Wessells, and for the DCCT/EDIC Research Group Effect of Intensive Glycemic Control and Diabetes Complications on Lower Urinary Tract Symptoms in Men With Type 1 Diabetes: Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study Diabetes Care, April 1, 2009; 32(4): 664 - 670. [Abstract] [Full Text] [PDF]
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L. D. Bash, E. Selvin, M. Steffes, J. Coresh, and B. C. Astor Poor Glycemic Control in Diabetes and the Risk of Incident Chronic Kidney Disease Even in the Absence of Albuminuria and Retinopathy: Atherosclerosis Risk in Communities (ARIC) Study Arch Intern Med, December 8, 2008; 168(22): 2440 - 2447. [Abstract] [Full Text] [PDF]
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 Diabetes Control and Complications Trial/Epidemiol Prolonged Effect of Intensive Therapy on the Risk of Retinopathy Complications in Patients With Type 1 Diabetes Mellitus: 10 Years After the Diabetes Control and Complications Trial Arch Ophthalmol, December 1, 2008; 126(12): 1707 - 1715. [Abstract] [Full Text] [PDF]
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G. Musen, A. M. Jacobson, C. M. Ryan, P. A. Cleary, B. H. Waberski, K. Weinger, W. Dahms, M. Bayless, N. Silvers, J. Harth, et al. Impact of Diabetes and Its Treatment on Cognitive Function Among Adolescents Who Participated in the Diabetes Control and Complications Trial Diabetes Care, October 1, 2008; 31(10): 1933 - 1938. [Abstract] [Full Text] [PDF]
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I. H. de Boer, B. Kestenbaum, T. C. Rue, M. W. Steffes, P. A. Cleary, M. E. Molitch, J. M. Lachin, N. S. Weiss, J. D. Brunzell, and for the Diabetes Control and Complications Trial ( Insulin Therapy, Hyperglycemia, and Hypertension in Type 1 Diabetes Mellitus Arch Intern Med, September 22, 2008; 168(17): 1867 - 1873. [Abstract] [Full Text] [PDF]
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 A H Berg and D B Sacks Haemoglobin A1c analysis in the management of patients with diabetes: from chaos to harmony J. Clin. Pathol., September 1, 2008; 61(9): 983 - 987. [Abstract] [Full Text] [PDF]
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A. D. Paterson, B. N. Rutledge, P. A. Cleary, J. M. Lachin, R. S. Crow, and for the Diabetes Control and Complications Trial/E The Effect of Intensive Diabetes Treatment on Resting Heart Rate in Type 1 Diabetes: The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Diabetes Care, August 1, 2007; 30(8): 2107 - 2112. [Abstract] [Full Text] [PDF]
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E. Selvin, C. M. Crainiceanu, F. L. Brancati, and J. Coresh Short-term Variability in Measures of Glycemia and Implications for the Classification of Diabetes Arch Intern Med, July 23, 2007; 167(14): 1545 - 1551. [Abstract] [Full Text] [PDF]
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 The Diabetes Control and Complications Trial/Epide Long-Term Effect of Diabetes and Its Treatment on Cognitive Function N. Engl. J. Med., May 3, 2007; 356(18): 1842 - 1852. [Abstract] [Full Text] [PDF]
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E. S. Kilpatrick, A. S. Rigby, and S. L. Atkin Variability in the Relationship between Mean Plasma Glucose and HbA1c: Implications for the Assessment of Glycemic Control Clin. Chem., May 1, 2007; 53(5): 897 - 901. [Abstract] [Full Text] [PDF]
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L. Fox, M. Dontchev, K. Ruedy, R. Beck, C. Kollman, L. Messer, J. Coffey, D. Wilson, E. Doyle, W. Tamborlane, et al. Relative Inaccuracy of the A1cNow in Children With Type 1 Diabetes Diabetes Care, January 1, 2007; 30(1): 135 - 137. [Full Text] [PDF]
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 P. A. Cleary, T. J. Orchard, S. Genuth, N. D. Wong, R. Detrano, J.-Y. C. Backlund, B. Zinman, A. Jacobson, W. Sun, J. M. Lachin, et al. The Effect of Intensive Glycemic Treatment on Coronary Artery Calcification in Type 1 Diabetic Participants of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Diabetes, December 1, 2006; 55(12): 3556 - 3565. [Abstract] [Full Text] [PDF]
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