AMCR Institute, Escondido, California 92026, USA.
Diabetes Technol Ther. 2009 Dec;11(12):749-55. doi: 10.1089/dia.2009.0075.
The purpose of this study was to evaluate new features and performance of the SEVEN PLUS System (DexCom, Inc., San Diego, CA), a real-time continuous glucose monitoring (CGM) device. This study is the first to evaluate the SEVEN PLUS device.
Fifty-three subjects were enrolled at three U.S. centers; 43 (81%) of the subjects had type 1 diabetes mellitus, and 10 (19%) had insulin-requiring type 2 diabetes mellitus. Subjects inserted and wore either one or two sensors for 7 days. A subgroup (n = 18) wore two sensors to track precision. Subjects participated in one 8-h in-clinic session with blood draws every 15 min on study Day 1, 4, or 7 to collect laboratory reference YSI instrument (YSI, Yellow Springs, OH) and self-measured plasma glucose (SMPG) reference measurements. For the remainder of the week, CGM was used as an adjunct to SMPG during home use.
The overall median absolute relative difference (ARD) versus YSI was 13.0%. Zones A and B of the Clarke Error Grid of CGM measurements were 73.8% and 22.1%, respectively. Precision ARD was 15.3 +/- 6.2% (mean +/- SD). The median ARD versus SMPG was 12.1%. Sensor life (89% lasted 7 days) was improved compared to the SEVEN device. The lag time obtained with various statistical measures between CGM and YSI were similar and estimated as a median of 8 min (interquartile range, 11 min) using the Pearson correlation coefficient. No serious adverse events or infectious complications were reported.
The performance of this new system compares favorably to the previous SEVEN device in terms of accuracy, precision, lag time, sensor life, and rate of data capture.
本研究旨在评估 SEVEN PLUS 系统（DexCom，Inc.，圣地亚哥，CA）的新功能和性能，该系统是一种实时连续血糖监测（CGM）设备。这是首次评估 SEVEN PLUS 设备的研究。
53 名受试者在三个美国中心入组；43 名（81%）受试者患有 1 型糖尿病，10 名（19%）受试者患有需要胰岛素的 2 型糖尿病。受试者插入并佩戴一个或两个传感器 7 天。一个亚组（n=18）佩戴两个传感器以跟踪精度。受试者在研究第 1、4 或 7 天参加了一个 8 小时的门诊检查，每 15 分钟采集一次血液样本来收集实验室参考 YSI 仪器（YSI，Yellow Springs，OH）和自我测量的血浆葡萄糖（SMPG）参考测量值。在接下来的一周内，CGM 在家庭使用期间作为 SMPG 的辅助手段。
与 YSI 相比，总体中位数绝对相对差异（ARD）为 13.0%。CGM 测量值的 Clarke 误差网格的 A 区和 B 区分别为 73.8%和 22.1%。精度 ARD 为 15.3+/-6.2%（平均值+/-标准差）。与 SMPG 相比，中位数 ARD 为 12.1%。与 SEVEN 设备相比，传感器寿命（89%持续 7 天）得到了改善。使用各种统计措施在 CGM 和 YSI 之间获得的滞后时间相似，使用 Pearson 相关系数估计为中位数 8 分钟（四分位距，11 分钟）。未报告严重不良事件或感染并发症。
就准确性、精度、滞后时间、传感器寿命和数据采集率而言，该新系统的性能与之前的 SEVEN 设备相当。
