Prevalence-dependent decision limits for the early detection of type 2 diabetes mellitus in venous blood, venous plasma and capillary blood during glucose challenge

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Abstract
The glycemia decision limits recommended by WHO/ADA for type 2 diabetes detection are derived from clinical signs in advanced stages of the disease. Since insulin secretion patterns and sensitivitity are impaired at the beginning of type 2 diabetes, this stage may be better suited to identify decision limits with higher diagnostic efficiency than those currently applied. Oral glucose tolerance tests were performed in 300 subjects. Glucose concentrations were measured at 30-min intervals in venous plasma, venous blood and capillary blood. Insulin concentrations in venous plasma, an insulin sensitivity index and body mass index were used to indicate a type 2 diabetic state. A multiple logistic regression procedure was "trained" using only subjects "clearly" considered to be non-diseased or diseased based on an oral glucose tolerance test according to WHO criteria. This insulin algorithm was applied to the whole study group, leading to definitive classification into the non-diseased or the diseased group. This a posteriori classification was used to identify cutoff values with the highest diagnostic efficiency. The diagnostic efficiency was significantly higher when decision limits lower than the WHO recommendations for glucose concentrations were applied in a preselected subpopulation and in all three sample systems tested, e.g., 9.49 mmol/L (171 mg/dL) for venous plasma and 8.94 mmol/L (161 mg/dL) for capillary blood in the 2-h post-load state. The optimized and WHO 2-h cutoff values corresponded to a disease prevalence of 28% and approximately 5% (20% in the fasting state), respectively. Diagnostic efficiency was higher in the 2-h post-load than in the fasting state. Combining fasting values with 2-h post-load values did not further improve the diagnostic efficiency. Glucose concentrations determined from capillary blood were as efficient as those from venous blood or plasma. The number of diabetic subjects detected differed considerably between capillary blood and venous plasma for the WHO/ADA cutoff values, but not for the optimized cutoff values. The efficiency of type 2 diabetes diagnosis can be improved by optimizing cutoff values according to disease prevalence. Unexpectedly, the optimized 2-h post-load cutoff was lower for capillary blood than for venous plasma. It is proposed to identify a risk group e.g., by characteristics of the metabolic syndrome in which the 2-h post-challenge concentration is determined using lower cut-off values than presently recommended.