Glycated albumin as a biomarker for diagnosis of diabetes mellitus: A systematic review and meta-analysis

BACKGROUND Glycated albumin(GA), the non-enzymatic glycation product of albumin in plasma, became a glycemic marker in the beginning of the 21 st century. The assay is not affected by hemoglobin levels and reflects the glycemic status over a shorter period as compared to Hb A1 c measurements. Thus, GA may contributes as an intermediate glucose index in the current diabetes mellitus(DM) diagnostic system.AIM To search and summarize the available data on glycated albumin measurements required for the diagnosis of diabetes mellitus.METHODS Databases, including Pub Med, Embase, Web of Science, and Cochrane Central Register of Controlled Trials(CENTRAL), among others, were systematically searched. The Quality Assessment of Diagnostic Accuracy Studies-2 tool was applied for the assessment of quality, and the bivariate model was used to pool the sensitivity and specificity. The hierarchical summary receiver operator characteristic curves(HSROC) model was utilized to estimate the summary receiver operating characteristics curve(SROC). Sensitivity analysis was performed to investigate the association of the study design and patient characteristics with the test accuracy and meta-regression to find the source of heterogeneity.RESULTS Three studies regarding gestational diabetes mellitus(GDM) and a meta-analysis of 16 non-GDM studies, comprising a total sample size of 12876, were included in the work. Results reveal that the average cut-off values of GA reported for the diagnosis of GDM diagnosis was much lower than those for non-GDM. For non-GDM cases, diagnosing DM with a circulating GA cut-off of 14.0% had a sensitivity of 0.766(95%CI: 0.539, 0.901), specificity of 0.687(95%CI: 0.364, 0.894), and area under the curve of 0.80(95%CI: 0.76, 0.83) for the SROC. The estimated SROC at different GA cut-off values for non-GDM exhibited that the average location parameter lambda of 16 non-GDM studies was 2.354(95%CI: 2.002, 2.707), and the scale parameter beta was-0.163(95%CI:-0.614, 0.288). These nonGDM studies with various thresholds had substantial heterogeneity, which may be attributed to the type of DM, age, and body mass index as possible sources.CONCLUSION Glycated albumin in non-DM exhibits a moderate diagnostic accuracy. Further research on the diagnostic accuracy of GA for GDM and combinational measurements of GA and other assays is suggested.