Barbara Davis Center for Childhood Diabetes, School of Medicine, University of Colorado at Denver, Aurora, Colorado 80045, USA.
Diabetes Technol Ther. 2009 Feb;11(2):65-72. doi: 10.1089/dia.2008.0109.
This study evaluated the accuracy and safety of two continuous glucose monitoring (CGM) systems, the SEVEN (DexCom, San Diego, CA) and the Navigator (Abbott Diabetes Care, Alameda, CA), with the YSI laboratory measurements of blood glucose (blood glucose meter manufactured by YSI, Yellow Springs, OH), when worn concurrently in adults with type 1 diabetes.
Fourteen subjects with type 1 diabetes, 33 +/- 6 (mean +/- SD) years old, were enrolled in this study. All subjects wore both sensors concurrently over three consecutive 5-day CGM sessions (15-day wear). On Days 5, 10, and 15, subjects participated in an 8-h in-clinic session where measurements from the CGM systems were collected and compared with YSI measurements every 15 min. At the end of Day 5 and 10 in-clinic sessions, the sensors were removed, and new sensors were inserted for the following CGM session despite the SEVEN system's recommended use for up to 7 days.
The mean absolute relative difference (ARD) for the two CGM devices versus YSI was not different: 16.8% and 16.1% for SEVEN and Navigator, respectively (P = 0.38). In the hypoglycemic region (YSI value <80 mg/dL), the mean ARD for SEVEN was lower than for Navigator (21.5% vs. 29.8%, respectively; P = 0.001). The data analyses were similar when compared with self-monitoring of blood glucose (SMBG) values. Thirteen additional Navigator replacement devices were issued compared to two for the SEVEN. A total of three versus 14 skin reactions were reported with the SEVEN and Navigator insertion area, respectively.
Glucose measurements with the SEVEN and Navigator were found to be similar compared with YSI and SMBG measurements, with the exception of the hypoglycemic range where the SEVEN performed better. However, the Navigator caused more skin area reactions.
本研究评估了两种连续血糖监测（CGM）系统，SEVEN（DexCom，圣地亚哥，加利福尼亚）和 Navigator（雅培糖尿病护理，阿拉米达，加利福尼亚），与 YSI 实验室测量的血糖（血糖计由 YSI，Yellow Springs，俄亥俄州制造），当同时在患有 1 型糖尿病的成年人中佩戴时的准确性和安全性。
14 名患有 1 型糖尿病的受试者，33 +/- 6（均值 +/- SD）岁，参加了这项研究。所有受试者在三个连续的 5 天 CGM 疗程（15 天佩戴）中同时佩戴两个传感器。在第 5、10 和 15 天，受试者参加了 8 小时的门诊就诊，在此期间收集 CGM 系统的测量值，并每隔 15 分钟与 YSI 测量值进行比较。在第 5 天和第 10 天门诊就诊结束时，尽管 SEVEN 系统建议使用长达 7 天，但仍移除传感器并插入新的传感器，以进行以下 CGM 疗程。
两种 CGM 设备与 YSI 的平均绝对相对差异（ARD）无差异：SEVEN 和 Navigator 分别为 16.8%和 16.1%（P = 0.38）。在低血糖区域（YSI 值<80mg/dL），SEVEN 的平均 ARD 低于 Navigator（分别为 21.5%和 29.8%；P = 0.001）。当与自我监测的血糖（SMBG）值进行比较时，数据分析是相似的。与 SEVEN 相比，额外发放了 13 个 Navigator 替换设备，而只有 2 个 SEVEN。SEVEN 和 Navigator 插入区域分别报告了 3 次和 14 次皮肤反应。
与 YSI 和 SMBG 测量值相比，SEVEN 和 Navigator 的葡萄糖测量值被发现相似，除了低血糖范围，SEVEN 的表现更好。然而，Navigator 引起了更多的皮肤区域反应。
