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J Diabetes Investig. 2018 Mar;9(2):286-293. doi: 10.1111/jdi.12699. Epub 2017 Jul 7.

Performance of a new real-time continuous glucose monitoring system: A multicenter pilot study.

Zhou J1,2,3,4,5, Zhang S6, Li L7, Wang Y1,2,3,4,5, Lu W1,2,3,4,5, Sheng C7, Li Y6, Bao Y1,2,3,4,5, Jia W1,2,3,4,5.

Author information

1
Department of Endocrinology and Metabolism, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, China.
2
Shanghai Clinical Center for Diabetes, Shanghai, China.
3
Shanghai Key Clinical Center for Metabolic Disease, Shanghai, China.
4
Shanghai Diabetes Institute, Shanghai, China.
5
Shanghai Key Laboratory of Diabetes Mellitus, Shanghai, China.
6
Department of Endocrinology and Metabolism, Huashan Hospital, Shanghai Medical College, Fudan University, Shanghai, China.
7
Department of Endocrinology and Metabolism, Shanghai Tenth People's Hospital, School of Medicine, Tongji University, Shanghai, China.

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.

KEYWORDS:

Accuracy; Continuous glucose monitoring; Error grid analysis

PMID:
28563974
PMCID:
PMC5835467
DOI:
10.1111/jdi.12699
[Indexed for MEDLINE]
Free PMC Article

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