Evaluation of the HemoCue HbA1c 501 System in Primary Care Settings

Abstract The routine measurement of hemoglobin A1c (HbA1c) is recommended by major clinical diabetes organizations. By providing results rapidly with point-of-care devices, more timely decisions regarding optimal treatment can be made, and studies have confirmed that immediate feedback of HbA1c results improves glycemic control in patients with type 1 and insulin-treated type 2 diabetes mellitus. The aim of this study was to evaluate the performance of the HemoCue HbA1c 501 during regular use in primary care settings. The results verify that the HemoCue HbA1c 501 system is accurate and easy to use in the hands of the intended user in a primary care setting. This is based on the fact that more than 96% of results fall within 6% bias and a total coefficient of variation of less than 2%, thereby fulfilling the latest National Glycohemoglobin Standardization Program requirements.