HbA1c of 6.5% to diagnose diabetes mellitus – Does it work for us? – The Bellville South Africa study

Diabetes is a disease fuelled by the increasing worldwide obesity epidemic with significant morbidity and mortality, and the World Health Organization (WHO) estimates that it will affect 366 million individuals worldwide by 2030 [1]. Its diagnosis was previously made either according to the WHO criteria which were updated in 2006 [2] using a fasting blood glucose sample and subsequent 75 g oral glucose tolerance test (OGTT) with blood taken for glucose determination again 2 hours after an oral glucose challenge, or according to the American Diabetes Association (ADA) criteria which were updated in 2005 [3], using only a fasting blood glucose level. Using ADA criteria only has been found to underestimate the prevalence of diabetes and misses those individuals with impaired glucose tolerance (IGT), a pre-diabetic state [4]. The disadvantage of both these diagnostic approaches is that they require the patient to fast and if need confirming, would require a second fasting sample. Glucose also has a large biological and diurnal variation and depends on recent carbohydrate intake and the OGTT is fairly invasive [5]. In 2010, the ADA updated their diagnostic criteria to include an OGTT as well [6]. On the other hand, HbA1c, which is formed by the attachment of glucose to various amino groups of haemoglobin and has been used since 1977 for the long-term (2–3 month) glycaemic control follow up of diabetes, has recently been advocated by the ADA as a diagnostic tool. In 2009, the International Expert Committee of the ADA issued a statement proposing an HbA1c value of 6.5% (48 mmol/mol) as a diagnostic level for the diagnosis of diabetes. This value was chosen, as it was found to be the value after which the incidence of retinopathy, a common complication that often is present before the actual diagnosis of diabetes is made, is increased [7]. This test would be advantageous, as it does not require a fasting sample and has much less intraindividual variation.University Research Fund of the Cape Peninsula University of Technology, South Africa and the National Health Laboratory Services South Africa (grant number 94122