Randomised controlled trial of near-patient testing for glycated haemoglobin in people with type 2 diabetes mellitus

Background Tight glycaemic control in people with type 2 diabetes can lead to a reduction in microvascular and possibly macrovascular complications. The use of near-patient (rapid) testing offers a potential method to improve glycaemic control. Aim To assess the effect and costs of rapid testing for glycated haemoglobin (HbA1c) in people with type 2 diabetes. Design of study Pragmatic open randomised controlled trial. Setting Eight practices in Leicestershire, UK. Method Patients were randomised to receive instant results for HbA1c or to routine care. The principal outcome measure was the proportion of patients with an HbA1c <7% at 12 months. We also assessed costs for the two groups. Results Of the 681 patients recruited to the study 638 (94%) were included in the analysis. The mean age at baseline was 65.7 years (SD = 10.8 years) with a median (interquartile range) duration of diabetes of 4 (1-8) years. The proportion of patients with HbA1c <7% did not differ significantly between the intervention and control groups (37 versus 38%, odds ratio 0.95 [95% confidence interval = 0.69 to 1.31]) at 12 months follow up. The total cost for diabetes-related care was 2390 per patient for the control group and 2370 for the intervention group. This difference was not statistically significant. Conclusion Near-patient testing for HbA1c alone does not lead to outcome or cost benefits in managing people with type 2 diabetes in primary care. Further research is required into the use of rapid testing as part of an optimised patient management model including arrangements for patient review and testing.