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DOI: 10.1111/j.1464-5491.2010.03159.x
Abstract
Aim To analyse the performance of HbA1c in diagnosing Type 2 diabetes based on fasting plasma glucose and or 2-h plasma
glucose measurements after a 75-g oral glucose tolerance test.
Methods This is a study of diagnostic test accuracy in individuals referred to the Clinical Pathology Department for oral
glucose tolerance testing. After fasting overnight, HbA1c, fasting plasma glucose and 2-h plasma glucose were measured. The
receiver operating characteristic curve was used to evaluate the diagnostic performance of HbA1c.
Results Four hundred and ninety-eight subjects (195 male, mean age 56 years) were enrolled and 115 (23.1%) were diagnosed
with diabetes according to glucose-based methods and only 56 (11.2%) individuals were identified by HbA1c 6.5%
(48 mmol mol) (sensitivity 20.9%, specificity 95.3%). There is poor agreement between the newly recommended criterion and
the current glucose-based diagnostic criteria (j = 0.217; P < 0.001), probably because the diagnostic methods identify different
populations of patients. Adding a glucose-based method into an algorithm, as proposed by the UK Department of Health,
improved HbA1c performance.
Conclusions HbA1c 6.5% (48 mmol mol) showed limited sensitivity to diabetes diagnosis, although with high specificity.
The results suggest that this cut-off point would not be enough to diagnose diabetes. Its use as the sole diabetes diagnostic test
should be interpreted with caution to assure the correct classification of diabetic individuals.
Diabet. Med. 28, 3135 (2011)
Keywords diabetes, diagnosis, diagnostic tests, glycated hemoglobin
HbA1c
< 6.0% 66.4% 6.5%
(< 42 mmol mol) (4246 mmol mol) ( 48 mmol mol)
n 331 111 56
Sex (man woman) 139 192 35 76 21 35
Age (years) 53 13 61 11 61 12
BMI 27 5.6 28 6.0 30 6.3
Waist circumference (cm) 94 17 97 18 103 13
Without diabetes 113 (34.1%) 8 (7.2%) 1 (1.78%)
Pre-diabetes 168 (50.7%) 67 (60.3%) 26 (46.4%)
Diabetes mellitus 50 (15.1%) 36 (32.4%) 29 (51.7%)
Hypertension 162 (48.9%) 79 (71.1%) 44 (78.5%)
Family history of diabetes 162 (48.9%) 61 (54.9%) 30 (53.5%)
Family history of hypertension 238 (71.9%) 75 (67.5%) 40 (71.4%)
Family history of cardiovascular disease 207 (62.5%) 72 (64.8%) 40 (71.4%)
Fasting plasma glucose (mmol l) 5.7 0.7 6.2 0.8 7.6 2.5
2-h plasma glucose (mmol l) 7.4 2.9 8.8 4.0 12.7 5.8
HbA1c (%) 5.3 0.4 6.1 0.14 7.2 1.5
Creatinine ((mol l) 74.2 17.7 81.3 17.7 83.0 16.8
n = 498.
Data are mean sd or median (interval).
of patients with diabetes will not be identified. In addition, we diagnostic test should be interpreted with caution to assure the
observed an increase in false positive results using the cut-off correct classification of diabetic individuals.
point of HbA1c 6.0% (42 mmol mol); 93% of the
individuals misclassified presented some degree of glucose
Competing interests
abnormality.
These findings suggest that the HbA1c method and the glucose- Nothing to declare.
based methods identify different patient populations.
Several studies had suggested lower values than the present
Acknowledgements
recommended values of HbA1c 6.5% (48 mmol mol) to
diagnose diabetes [35]. Besides, the cut-off value of HbA1c We thank the staff of the Pre-Analytical Unit and the Clinical
> 6.1% (43 mmol mol) presented high sensitivity and Biochemistry Unit at the Clinical Pathology Department for
specificity to screen for diabetes in high-risk individuals, OGTT performance and HbA1c analysis, respectively. This study
and the combination of HbA1c and fasting plasma glucose was supported by Fundo de Incentivo a Pesquisa (FIPE) to
improved the sensitivity for both tests alone [4]. Moreover, Hospital de Clnicas de Porto Alegre (HCPA). GC and JC
there is a continuous relationship between fasting plasma were recipients of scholarships from Coordenacao de
glucose and HbA1c and cardiovascular risk. It has been Aperfeicoamento de Pessoal de Ensino Superior (CAPES) and
suggested that individuals with an HbA1c level of 5.66.1% Fundacao de Amparo a Pesquisa do Rio Grande do Sul
(3843 mmol mol) and a fasting plamsa glucose level of (FAPERGS), respectively.
5.66.3 mmol l are at greatest risk for cardiovascular disease
and should be targeted for further evaluation [10]. In a
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