Ji Linong, Guo Xiaohui, Guo Lixin, Ren Qian, Yu Nan, Zhang Jie
1 Peking University People's Hospital, Beijing, China.
2 Peking University First Hospital, Beijing, China.
J Diabetes Sci Technol. 2017 Mar;11(2):290-295. doi: 10.1177/1932296816662884. Epub 2016 Sep 25.
Flash glucose monitoring is a new glucose sensing technique that measures interstitial glucose levels for up to 14 days and does not require any calibration. The aim of this study is to evaluate the performance of the new system in Chinese patients with diabetes.
A multicenter, prospective, masked study was performed in a total of 45 subjects with diabetes. Subjects wore 2 sensors at the same time, for up to 14 days. The accuracy was evaluated against capillary blood glucose (BG) and venous Yellow Springs Instrument (YSI; Yellow Springs, OH) measurements. During all 14 days, subjects were asked to perform at least 8 capillary BG tests per day. Each subject attended 3 days of 8-hour clinic sessions to measure YSI and sensor readings every 15 minutes.
Forty subjects had evaluable glucose readings, with 6687 of 6696 (99.9%) sensor and capillary BG pairs within consensus error grid zones A and B, including 5824 (87.0%) in zone A. The 6969 sensor and venous YSI pairs resulted in 6965 (99.9%) pairs within zones A and B, including 5755 (82.6%) in zone A. The sensor pairs with BG and YSI result in mean absolute relative difference (MARD) of 10.0% and 10.7%, respectively. Overall between-sensor coefficient of variation (CV) was 8.0%, and the mean lag time was 3.1 (95% confidence interval 2.54 to 4.29) minutes.
The system works well for people with diabetes in China, and it is easy to wear and use.
动态葡萄糖监测是一种新的葡萄糖传感技术，可测量长达14天的组织间液葡萄糖水平，且无需任何校准。本研究的目的是评估该新系统在中国糖尿病患者中的性能。
对总共45例糖尿病患者进行了一项多中心、前瞻性、盲法研究。受试者同时佩戴2个传感器，持续长达14天。通过与毛细血管血糖（BG）和静脉血葡萄糖氧化酶法（YSI；美国俄亥俄州黄泉市）测量结果进行对比来评估准确性。在整个14天期间，要求受试者每天至少进行8次毛细血管BG检测。每位受试者参加为期3天、每天8小时的门诊，每15分钟测量一次YSI和传感器读数。
40例受试者有可评估的葡萄糖读数，6696对传感器与毛细血管BG读数中，有6687对（99.9%）在一致性误差网格A区和B区内，其中5824对（87.0%）在A区。6969对传感器与静脉血YSI读数中，有6965对（99.9%）在A区和B区内，其中5755对（82.6%）在A区。传感器与BG和YSI读数的配对平均绝对相对差值（MARD）分别为10.0%和10.7%。总体传感器间变异系数（CV）为8.0%，平均滞后时间为3.1（95%置信区间2.54至4.29）分钟。
该系统在中国糖尿病患者中效果良好，且佩戴和使用方便。
