Open AccessPerformance of a new real‐time continuous glucose monitoring system: A multicenter pilot study
Author(s) -
Zhou Jian,
Zhang Shuo,
Li Liang,
Wang Yufei,
Lu Wei,
Sheng Chunjun,
Li Yiming,
Bao Yuqian,
Jia Weiping
Publication year - 2018
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/jdi.12699
Subject(s) - medicine , continuous glucose monitoring , hypoglycemia , confidence interval , mean difference , type 1 diabetes , diabetes mellitus , plasma glucose , type 2 diabetes , reference values , nuclear medicine , endocrinology
Aims/Introduction The present study aimed to investigate the performance of a new real‐time continuous glucose monitoring system. Materials and Methods Interstitial glucose levels were monitored for 7 days in 63 patients with type 1 or type 2 diabetes using the Medtrum A6 TouchCare ® CGM System. Venous blood was collected on a randomized day of the wear period. Plasma glucose levels were measured as reference values. Results Among 1,678 paired sensor–reference values, 90.5% (95% confidence interval 89.1–91.9%) were within ±20%/20 mg/dL of the reference values, with a mean absolute relative difference of 9.1 ± 8.7% (95% CI : 8.9–9.2%). The percentages of paired sensor–reference values falling within zone A and B of the Clarke error grid analysis ( EGA ) and the type 1 diabetes consensus EGA were 99.1 and 99.8%. Continuous EGA showed that the percentages of accurate readings, benign errors, and erroneous readings were 89.9, 6.3 and 3.8%, respectively. Surveillance EGA showed that 90.6, 9.2, and 0.2% of sensor–reference values with no, slight and lower moderate risk, respectively. The mean absolute relative difference was 16.6, and 96.0% of the sensor values fell within zones A and B of the consensus EGA for hypoglycemia. More than 85% of sensor values were within ±20%/20 mg/ dL of reference values, the mean absolute relative difference was <11, and >99.5% of the sensor values fell in zones A and B of the consensus EGA . Conclusions The Medtrum real‐time continuous glucose monitoring system was numerically and clinically accurate over a large glucose range across 7 days of wear.