Abstract
Background:
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.
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.
Get full access to this article
View all access options for this article.