Hemoglobin A1c measurements over nearly two decades: Sustaining comparable values throughout the diabetes control and complications trial and the epidemiology of diabetes interventions and complications study

Michael W Steffes, Patricia Cleary, David Goldstein, Randie Little, Hsiao Mei Wiedmeyer, Curt Rohlfing, Jack England, Jean Bucksa, Maren Nowicki

Research output: Contribution to journalArticlepeer-review

103 Scopus citations

Abstract

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)%]. Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)753-758
Number of pages6
JournalClinical chemistry
Volume51
Issue number4
DOIs
StatePublished - Apr 2005

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