New Features and Performance of a Next-Generation SEVEN-Day Continuous Glucose Monitoring System with Short Lag Time

被引:41
作者
Bailey, Timothy [1 ]
Zisser, Howard [2 ]
Chang, Anna [3 ]
机构
[1] AMCR Inst Inc, Escondido, CA 92026 USA
[2] Sansum Diabet Res Inst, Santa Barbara, CA USA
[3] John Muir Phys Network Clin Res Ctr, Concord, CA USA
关键词
IMPROVED METABOLIC-CONTROL; CHILDREN; EXCURSIONS;
D O I
10.1089/dia.2009.0075
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background: The purpose of this study was to evaluate new features and performance of the SEVEN(R) 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. Methods: 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. Results: 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. Conclusions: 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.
引用
收藏
页码:749 / 755
页数:7
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