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The Utility of HbA1c as a Diagnostic Criterion of Diabetes
Hee-Jung Kim1, Eun Young Choi, Eal Whan Park
1Department of Family Medicine, Dankook University College of Medicine, Cheonan, Korea.
Insights
Hemoglobin A1c (HbA1c) testing underestimated diabetes prevalence compared to 2003 ADA criteria in high-risk individuals. The optimal HbA1c diagnostic cut-off was determined to be 6.45%.
Area of Science:
- Endocrinology
- Clinical Diagnostics
- Diabetes Mellitus Research
Background:
- Hemoglobin A1c (HbA1c) is a key biomarker for diabetes diagnosis.
- The 2003 American Diabetes Association (ADA) criteria are a standard for diabetes diagnosis.
- Investigating the diagnostic utility of HbA1c is crucial for accurate diabetes detection.
Purpose of the Study:
- To compare the diagnostic accuracy of HbA1c criteria with the 2003 ADA criteria for diabetes diagnosis.
- To determine the optimal cut-off value for HbA1c in diagnosing diabetes using receiver operating characteristic (ROC) curves.
- To assess the prevalence of newly diagnosed diabetes using both criteria in high-risk individuals.
Main Methods:
- Study included 224 non-diabetic subjects with fasting plasma glucose > 100 mg/dL.
- Subjects underwent a 75g oral glucose tolerance test (OGTT).
- Diabetes diagnosis was established using the 2003 ADA criteria and HbA1c levels.
Main Results:
- HbA1c criteria (≥6.5%) identified fewer diabetes cases (47.8%) than 2003 ADA criteria (58.2%), underestimating prevalence.
- HbA1c at 6.5% showed 73.5% sensitivity and 89.1% specificity compared to ADA criteria.
- The optimal HbA1c cut-off for diabetes diagnosis was 6.45% (AUC=0.85), with moderate agreement (kappa=0.60).
Conclusions:
- HbA1c testing, at a 6.5% threshold, underestimates diabetes prevalence in high-risk individuals compared to 2003 ADA criteria.
- An HbA1c cut-off of 6.45% provides a balance of sensitivity and specificity for diabetes diagnosis.
- Findings suggest HbA1c is a valuable, though not perfect, tool for diabetes screening and diagnosis.
Background:
Hemoglobin A1c (HbA1c) was adopted as a new standard criterion for diagnosing diabetes. We investigated the diagnostic utility of HbA1c by comparing the 2003 American Diabetes Association (ADA) diagnostic criteria of diabetes with HbA1c of 6.5%. Furthermore, the cut-off value for HbA1c was investigated using receiver operating characteristic curves.
Methods:
This study included 224 subjects without a history of diabetes that had a fasting plasma glucose level of above 100 mg/dL. The subjects had undergone a 75 g oral glucose tolerance test, and diabetes was defined as according to 2003 ADA criteria.
Results:
The prevalence of newly diagnosed diabetes was 58.2% by the 2003 ADA criteria, and 47.8% by HbA1c of 6.5%, which underestimated the prevalence of diabetes. Compared with the 2003 ADA criteria, the sensitivity and specificity of HbA1c of 6.5% were 73.5% and 89.1%, respectively. The kappa index of agreement between 2003 ADA and HbA1c criteria was 0.60. The cut-off point of HbA1c for diagnosing diabetes was 6.45% (sensitivity, 73.3%; specificity, 88.2%; area under the curve, 0.85). HbA1c was significantly associated with fasting glucose (r = 0.82, P < 0.01), postprandial glucose (r = 0.78, P < 0.01), and homeostasis model assessment of insulin resistance (r = 0.16, P < 0.05).
Conclusion:
For high risk patients whose fasting glucose was more than 100 mg/dL, HbA1c criterion underestimated the prevalence of newly diagnosed diabetes compared to the 2003 ADA criteria, and showed moderate agreement. The cut-off value for HbA1c was 6.45%, which was similar to the recommended diagnostic criterion of HbA1c by the 2009 ADA.
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