Are European standard deviation targets for haemoglobin A1c too strict?

The Diabetes Control and Complications Trial (DCCT) has provided objective evidence for desirable glycaemic control in Type 1 patients and defines the benefits of good glycaemic control in terms of haemoglobin A1c (HbA1c) values. However, HbA1c assays vary, leading to suggestions that glycaemic control be classified according to numbers of standard deviations (SD) from a local non-diabetic population mean. We have classified the glycaemic control of 339 UK Type 1 diabetic patients (182 male, 157 female, median age 36 (range 15-74) years) using the DCCT to set HbA1c targets and compared this with the SD method. Using age matched controls (mean HbA1c 4.02%, SD 0.28%, n=106), SD guidelines classified 1% of patients into good (HbA1c <3SD from reference mean), 4% into borderline (3-5SD) and 95% into poor (>5SD) glycaemic control. When calibrating the same instrument to the DCCT analyser (r=0.996), 37% of patients had HbA1c results lower than the 7% median value found in the intensively treated DCCT group, while only 12% of patients had values greater than the 9% conventionally treated median HbA1c. DCCT subjects with HbA1c values of less than 8% belonged predominantly to the intensively treated group. In this study, 71% of patients fell into this category. Thus, guidelines based on numbers of SD away from a non-diabetic mean may overestimate the glycaemic control required to reduce microvascular complications in Type 1 patients. Standardizing to DCCT targets is more appropriate.