Evaluation of a new blood glucose monitoring system with auto-calibration for home and hospital bedside use

Abstract

A new self-calibrating blood glucose monitoring system (BGMS) was evaluated in a series of clinical studies with both ambulatory subjects and with hospitalized patients. The new BGMS requires a 0.6 μL sample volume, provides results in 15 s, and uses a glucose dehydrogenase chemistry that is oxygen independent. In the first study, Ascensia ® Contour™ meters calibrated to whole blood were tested by health care professionals (HCP) and lay users at two clinical sites. Both HCPs and lay users obtained results that fulfilled the ISO 15197:2003 criteria that 95% of self-monitoring blood glucose (SMBG) measurements should fall within ±20% (for blood glucose (BG) concentrations ≥ 4.2 mmol/L or ±0.83 mmol/L for BG concentrations < 4.2 mmol/L) of the laboratory value. Lay users and HCPs obtained 97.2 and 96.7% of glucose results within ISO criteria, respectively. In a second study, HCPs assayed blood samples from patients at the hospital bedside using meters calibrated to give whole blood glucose and meters calibrated to give plasma glucose results. Overall, 94.7% of the measurements met the ISO 15197:2003 criteria. Most lay subjects rated the BGMS as either excellent or very good in a questionnaire, and were able to use it properly without training. These findings indicate that this new BGMS is a convenient and accurate instrument system suitable for both hospital bedside use by HCPs and for SMBG by people who routinely monitor their blood glucose.