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

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 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.

Evaluation of a new blood glucose monitoring system with auto-calibration.

BACKGROUND: The Ascensia CONTOUR System (Bayer HealthCare LLC, Elkhart, IN) is a new blood glucose (BG) monitoring system (BGMS) that uses glucose dehydrogenase chemistry and that combines low sample volume, fast response time, an auto-control marking feature, and an auto-calibration function in a small package. METHODS: The system was evaluated at four diabetes clinics with ambulatory subjects who had diabetes. The BGMS was tested by both health care professionals (HCPs) and lay users. It was also evaluated at high altitude (10,200 feet) and, in conjunction with the Ascensia MICROLET VACULANCE (Bayer), for use with samples obtained from four alternative anatomical sites. RESULTS: When the system was used with blood from fingersticks, both lay users and HCPs obtained results that fulfilled the International Organization for Standardization (ISO) 15197:2003 accuracy criteria, which advocate that 95% of BG measurements should fall within +/-15 mg/dL (for BG concentrations <75 mg/dL) or +/-20% (for BG concentrations > or = 75 mg/dL) of the laboratory value. Lay users obtained 96.9% of glucose results, and HCPs obtained 96.4% of glucose results, within ISO accuracy criteria. People with diabetes who had no prior experience using the system also obtained acceptable results (97.0%), as did the HCP using fingerstick samples from subjects in the high altitude study (97.0%). Among the alternative anatomical sites tested, only the results from the palm met the ISO criteria (97.5%), although the results from all four sites (palm, thigh, abdomen, and forearm) were clinically acceptable when assessed using error grid analysis. Most subjects rated the BGMS as either excellent or very good in a questionnaire, and were able to use it properly without training. CONCLUSIONS: These findings indicate that the Ascensia CONTOUR System, which does not require calibration by the user, is a convenient and accurate instrument with useful features for people who routinely monitor BG.