4.5 Article

The calculated versus the measured glycosylated haemoglobin (HbA1c) levels in patients with type 2 diabetes mellitus

Journal

JOURNAL OF CLINICAL LABORATORY ANALYSIS
Volume 35, Issue 8, Pages -

Publisher

WILEY
DOI: 10.1002/jcla.23873

Keywords

calculated glycosylated haemoglobin A; diabetes mellitus; fasting blood sugar; Sudan

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Diabetes mellitus (DM) is a chronic metabolic disorder that is increasing globally and associated with chronic complications. Glycosylated haemoglobin (HbA(1c)) is the gold standard for monitoring glycaemic control, but measurements are relatively expensive. A cross-sectional study was conducted to evaluate the agreement between calculated and measured HbA(1c) levels, which showed a significant correlation but lack of agreement between the two.
Background Diabetes mellitus (DM) is a chronic metabolic disorder that is increasing globally. It is associated with chronic complications that are more common among patients with poor glycaemic control. Glycosylated haemoglobin (HbA(1c)) is the gold standard for monitoring glycaemic control. Measurements of HbA(1c) are relatively expensive and not available in some remote areas of developing countries. Methods We conducted a cross-sectional study to evaluate the agreement between the calculated and measured HbA(1c) levels. The equation to compute the calculated HbA(1c) also incorporated the fasting blood glucose (FBG) level and was as follows: HbA(1c) = 2.6 + 0.03 x FBG (mg/dl). Result We enrolled 290 patients with type 2 DM in this study. Of these, 204 (70.3%) were females and the mean (SD) age was 54.9 (12.8) years. The mean (SD) diabetes duration was 6.8 (5.5) years. There were 211 (72.8%) patients using oral hypoglycaemic agents, 62 (21.4%) were using insulin and 17 (5.9%) were using both insulin and oral hypoglycaemic agents. There was a borderline difference between the mean (SD) calculated and measured HbA(1c) levels (p = 0.054). There was a significant correlation between the calculated and measured HbA(1c) (r = 0.595, p < 0.001). However, there was no agreement between the calculated and measured HbA(1c). The bias +/- SD (limits of agreement) for calculated versus measured HbA(1c) was -1.008 +/- 2.02% (-5.05, 2.032). Conclusion Despite the presence of a significant correlation between the calculated and measured HbA(1c), the calculated level has shown an unacceptable agreement with the measured HbA(1c).

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