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

Diabetes Research and Clinical Practice
Charles KiloDonald R Parker

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 0.6microL sample volume, provides results in 15s, 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> or =4.2mmol/L or +/-0.83mmol/L for BG concentrations<4.2mmol/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 wit...Continue Reading

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Citations

Apr 28, 2012·Journal of Diabetes Science and Technology·John WalshFrank Schwartz
Nov 7, 2009·The Korean journal of laboratory medicine·Dongheui AnWon Ki Min
Feb 20, 2010·Journal of Diabetes Science and Technology·Suzanne Austin Boren, William L Clarke

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