Weinstein Richard L, Schwartz Sherwyn L, Brazg Ronald L, Bugler Jolyon R, Peyser Thomas A, McGarraugh Geoffrey V
Diablo Clinical Research, 2255 Ygnacio Valley Rd., Suite M, Walnut Creek, CA 94598, USA.
Diabetes Care. 2007 May;30(5):1125-30. doi: 10.2337/dc06-1602. Epub 2007 Mar 2.
The purpose of this study was to compare the accuracy of measurements of glucose in interstitial fluid made with the FreeStyle Navigator Continuous Glucose Monitoring System with Yellow Springs Instrument laboratory reference measurements of venous blood glucose.
Fifty-eight subjects with type 1 diabetes, aged 18-64 years, were enrolled in a multicenter, prospective, single-arm study. Each subject wore two sensors simultaneously, which were calibrated with capillary fingerstick measurements at 10, 12, 24, and 72 h after insertion. Measurements from the FreeStyle Navigator system were collected at 1-min intervals and compared with venous measurements taken once every 15 min for 50 h over the 5-day period of sensor wear in an in-patient clinical research center. Periods of high rates of change of glucose were induced by insulin and glucose challenges.
Comparison of the FreeStyle Navigator measurements with the laboratory reference method (n = 20,362) gave mean and median absolute relative differences (ARDs) of 12.8 and 9.3%, respectively. The percentage in the clinically accurate Clarke error grid A zone was 81.7% and that in the in the benign error B zone was 16.7%. During low rates of change (< +/-1 mg x dl(-1) x min(-1)), the percentage in the A zone was higher (84.9%) and the mean and median ARDs were lower (11.7 and 8.5%, respectively).
Measurements with the FreeStyle Navigator system were found to be consistent and accurate compared with venous measurements made using a laboratory reference method over 5 days of sensor wear (82.5% in the A zone on day 1 and 80.9% on day 5).
本研究旨在比较使用FreeStyle Navigator连续血糖监测系统测量组织间液葡萄糖的准确性与黄泉仪器公司实验室静脉血葡萄糖参考测量的准确性。
58名年龄在18 - 64岁的1型糖尿病患者参与了一项多中心、前瞻性、单臂研究。每位受试者同时佩戴两个传感器，在插入后10、12、24和72小时用毛细血管指尖血糖测量进行校准。在住院临床研究中心，在传感器佩戴的5天时间内，以1分钟的间隔收集FreeStyle Navigator系统的测量数据，并与每15分钟进行一次的静脉测量数据进行比较，为期50小时。通过胰岛素和葡萄糖激发诱导血糖快速变化期。
将FreeStyle Navigator测量值与实验室参考方法（n = 20,362）进行比较，平均绝对相对差异（ARD）和中位数绝对相对差异分别为12.8%和9.3%。临床准确的克拉克误差网格A区的百分比为81.7%，良性误差B区的百分比为16.7%。在低变化率（< +/-1 mg x dl(-1) x min(-1)）期间，A区的百分比更高（84.9%），平均和中位数ARD更低（分别为11.7%和8.5%）。
与使用实验室参考方法进行的静脉测量相比，发现FreeStyle Navigator系统在传感器佩戴的5天内测量结果一致且准确（第1天A区为82.5%，第5天为80.9%）。
