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. 2008 Sep;23(9):1346-53.
doi: 10.1007/s11606-008-0661-6. Epub 2008 Jun 10.

Value of risk stratification to increase the predictive validity of HbA1c in screening for undiagnosed diabetes in the US population

Adit A Ginde  1 , Enrico Cagliero, David M Nathan, Carlos A Camargo Jr
Affiliations

Value of risk stratification to increase the predictive validity of HbA1c in screening for undiagnosed diabetes in the US population

Adit A Ginde et al. J Gen Intern Med. 2008 Sep.

Abstract

Background: Opportunistic screening using hemoglobin A1c (HbA1c) may improve detection of undiagnosed diabetes but remains controversial.

Objective: To evaluate the predictive validity of HbA1c as a screening test for undiagnosed diabetes in a risk-stratified sample of the US population.

Design: Weighted cross-sectional analysis of diabetes risk factors, HbA1c, and fasting plasma glucose (FPG) in National Health and Nutrition Examination Survey (NHANES), 1999-2004.

Subjects: Six thousand seven hundred and twenty-three NHANES participants from morning examination session, aged > or = 18 years and without prior physician-diagnosed diabetes.

Measurements: HbA1c and undiagnosed diabetes defined by FPG > or = 7.0 mmol/l (126 mg/dl).

Results: The estimated prevalence of undiagnosed diabetes in the US population was 2.8% (5.5 million people). HbA1c had strong correlation with undiagnosed diabetes, with an area under the receiver-operating characteristic curve of 0.93. Independent predictors of undiagnosed diabetes were older age, male sex, black race, hypertension, elevated waist circumference, elevated triglycerides, and low high-density lipoprotein cholesterol. We derived a risk score for undiagnosed diabetes and stratified participants into low (0.44% prevalence), moderate (4.1% prevalence), and high (11.1% prevalence) risk subgroups. In moderate and high risk groups, a threshold HbA1c value > or = 6.1% identified patients requiring confirmatory FPG; HbA1c < or = 5.4% identified patients for whom diabetes could be reliably excluded. Intermediate HbA1c (5.5-6.0%) may exclude diabetes in moderate, but not high risk groups).

Conclusions: Risk stratification improves the predictive validity of HbA1c in screening for undiagnosed diabetes in the US population. Although opportunistic screening with HbA1c would improve detection of undiagnosed diabetes, cost-effectiveness studies are needed before implementation of specific screening strategies using HbA1c.

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Figures

Figure 1
Figure 1
Receiver operating characteristic (ROC) curve for accuracy of hemoglobin A1c in predicting undiagnosed diabetes. Based on gold standard of fasting plasma glucose ≥7.0 mmol/l (126 mg/dl) to define undiagnosed diabetes. Area under the curve = 0.93 (95% CI, 0.91–0.95).
Figure 2
Figure 2
STARD diagram for detection of undiagnosed diabetes by risk stratification and hemoglobin A1c. Abbreviations: STARD, Standards for Reporting of Diagnostic Accuracy; HbA1c, hemoglobin A1c. Risk groups based on significant predictors of undiagnosed diabetes in multivariate analysis.
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