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An Assessment of HbA1c in Diabetes Mellitus and Pre-diabetes Diagnosis: a Multi-centered Data Mining Study

Muhittin A Serdar1, Mustafa Serteser2, Yasemin Ucal2

  • 1Department of Medical Biochemistry and Acibadem Labmed Laboratories, Acibadem Mehmet Ali Aydinlar University School of Medicine, Istanbul, Turkey. muhittin.serdar@acibadem.edu.tr.

Applied Biochemistry and Biotechnology
|July 14, 2019
PubMed

Insights

The HbA1c test shows limited diagnostic effectiveness for diabetes mellitus (DM) and pre-diabetes, especially compared to fasting plasma glucose (FPG). Further research is needed to clarify its role in DM diagnosis and management.

Area of Science:

  • Clinical diagnostics
  • Endocrinology
  • Biochemistry

Background:

  • Glycemic control in diabetes mellitus (DM) is commonly evaluated using the HbA1c test.
  • Controversial findings exist regarding the diagnostic utility of HbA1c for DM.
  • This study addresses the diagnostic effectiveness of HbA1c in a large patient cohort.

Purpose of the Study:

  • To investigate the diagnostic effectiveness of the HbA1c test in identifying diabetes mellitus (DM) and pre-diabetes.
  • To compare the diagnostic performance of HbA1c with fasting plasma glucose (FPG).
  • To evaluate the impact of age and gender on HbA1c diagnostic accuracy.

Main Methods:

  • Retrospective analysis of HbA1c and oral glucose tolerance test (OGTT) results from 6551 patients across 12 Turkish medical centers (2010-2016).
  • HbA1c measurements were performed using immunoturbidimetric methods on Roche systems.
  • Receiver Operating Characteristic (ROC) curve analysis was employed to determine diagnostic sensitivity, specificity, and Area Under the Curve (AUC).

Main Results:

  • For DM diagnosis, HbA1c at a cut-off of 41 mmol/mol (5.9%) showed 74.5% sensitivity, 87.1% specificity, and 0.866 AUC. At the universal cut-off of 48 mmol/mol (6.5%), sensitivity dropped to 32.4% with 99.9% specificity.
  • Fasting plasma glucose (FPG) demonstrated diagnostic performance with 71.3% sensitivity, 85.3% specificity, and 0.853 AUC.
  • HbA1c exhibited lower diagnostic accuracy for pre-diabetes (45.7% sensitivity, 76.4% specificity, 0.641 AUC at 39 mmol/mol or 5.7%).
  • Age and gender did not significantly impact HbA1c diagnostic values.

Conclusions:

  • HbA1c measurements present challenges in definitively diagnosing diabetes mellitus and show particularly low sensitivity for pre-diabetes detection.
  • The diagnostic contribution of HbA1c to FPG measurements remains questionable.
  • Further multi-center studies using diverse methodologies are recommended to establish the definitive role of HbA1c in diabetes diagnosis.

Keywords:
Diabetes mellitusFasting plasma glucoseHbA1cOGTT

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