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  • Title: Performance of a new real-time continuous glucose monitoring system: A multicenter pilot study.
    Author: Zhou J, Zhang S, Li L, Wang Y, Lu W, Sheng C, Li Y, Bao Y, Jia W.
    Journal: J Diabetes Investig; 2018 Mar; 9(2):286-293. PubMed ID: 28563974.
    Abstract:
    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.
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