Validation and effect on diabetes control of glycated haemoglobin (HbA1c) point-of-care testing

Abstract

Background. Optimal control of diabetes mellitus (DM) remains daunting globally. Point-of-care testing (POCT) for glycated haemoglobin (HbA1c) enables the clinician to make immediate management decisions and thereby improve DM control and complications. Better control is increasingly being striven for in developing countries where availability of POCT devices is limited.

Methods. Every alternate patient who visited the diabetes clinic at Edendale Hospital, Durban, South Africa, between 1 June 2017 and 31 August 2017 was invited to participate in the study. These patients made up the POCT group, with the remainder making up the control laboratory group. The POCT group had Quo-Test HbA1c POCT done at the clinic visit and their treatment was adjusted based on the HbA1c reading, while the control group received standard treatment. The two groups of patients were reviewed at 3 months to identify differences in diabetes control between them.

Results. Data from 266 patients were analysed (135 in the POCT group v. 131 in the control group). There was no significant difference between the price of the POCT and laboratory HbA1c tests (p=0.823). The POCT and laboratory HbA1c values showed good correlation at baseline (r=0.995; p<0.001). The two groups of patients were evenly matched in respect of most demographic and clinical variables. Patients in the POCT group showed a significant improvement in mean (standard deviation) glycaemic control between baseline and 3 months (9.61 (2.46) v. 8.98 (2.15); p<0.043). No improvement was noted in the control group (9.58 (2.49) v. 9.43 (2.15); p=0.823).

Conclusions. The Quo-Test HbA1c POCT had good correlation with standard laboratory methods in respect of both glycaemic control and price. Patients who had POCT at baseline showed a significant improvement in glycaemic control at 3 months. HbA1c POCT in the setting of a multifaceted approach to diabetes care has been shown to have definite benefits.