Sun Zeng-Mei, Du Yuan-Ze, Wang Su-Yuan, Sun Shu-Yao, Ye Yan, Sun Xue-Ping, Li Ming-Xia, He Hua, Long Wun-Chun, Zhang Cheng-Hui, Yao Xuan-Yu, Fan Wu-Yi, Wang Ling, Wu Yun-Hong
Department of Endocrinology and Metabolism, Hospital of the People's Government of the Tibet Autonomous Region in Chengdu, Chengdu 614000, Sichuan Province, China.
Department of Nursing, Hospital of Chengdu Office of the People's Government of Tibet Autonomous Region, Chengdu 610041, Sichuan Province, China.
World J Diabetes. 2024 Jun 15;15(6):1254-1262. doi: 10.4239/wjd.v15.i6.1254.
The FreeStyle Libre flash glucose monitoring (FGM) system entered the Chinese market in 2017 to complement the self-monitoring of blood glucose. Due to its increased usage in clinics, the number of studies investigating its accuracy has increased. However, its accuracy has not been investigated in highland popu-lations in China.
To evaluate measurements recorded using the FreeStyle Libre FGM system compared with capillary blood glucose measured using the enzyme electrode method in patients with type 2 diabetes (T2D) who had migrated within 3 mo from highlands to plains.
Overall, 68 patients with T2D, selected from those who had recently migrated from highlands to plains (within 3 mo), were hospitalized at the Department of Endocrinology from August to October 2017 and underwent continuous glucose monitoring (CGM) with the FreeStyle Libre FGM system for 14 d. Throughout the study period, fingertip capillary blood glucose was measured daily using the enzyme electrode method (Super GL, China), and blood glucose levels were read from the scanning probe during fasting and 2 h after all three meals. Moreover, the time interval between reading the data from the scanning probe and collecting fingertip capillary blood was controlled to < 5 min. The accuracy of the FGM system was evaluated according to the CGM guidelines. Subsequently, the factors influencing the mean absolute relative difference (MARD) of this system were analyzed by a multiple linear regression method.
Pearson's correlation analysis showed that the fingertip and scanned glucose levels were positively correlated ( = 0.86, = 0.00). The aggregated MARD of scanned glucose was 14.28 ± 13.40%. Parker's error analysis showed that 99.30% of the data pairs were located in areas A and B. According to the probe wear time of the FreeStyle Libre FGM system, MARD and MARD were 16.55% and 14.35%, respectively ( = 1.23, = 0.22). Multiple stepwise regression analysis showed that MARD did not correlate with blood glucose when the largest amplitude of glycemic excursion (LAGE) was < 5.80 mmol/L but negatively correlated with blood glucose when the LAGE was ≥ 5.80 mmol/L.
The FreeStyle Libre FGM system has good accuracy in patients with T2D who had recently migrated from highlands to plains. This system might be ideal for avoiding the effects of high hematocrit on blood glucose monitoring in populations that recently migrated to plains. MARD is mainly influenced by glucose levels and fluctuations, and the accuracy of the system is higher when the blood glucose fluctuation is small. In case of higher blood glucose level fluctuations, deviation in the scanned glucose levels is the highest at extremely low blood glucose levels.
FreeStyle Libre 闪式葡萄糖监测(FGM)系统于2017年进入中国市场,以补充血糖自我监测。由于其在临床中的使用增加,研究其准确性的研究数量也有所增加。然而,在中国的高原人群中尚未对其准确性进行研究。
评估使用FreeStyle Libre FGM系统记录的测量值与采用酶电极法测量的毛细血管血糖值相比,在3个月内从高原迁移至平原的2型糖尿病(T2D)患者中的情况。
总体而言,从最近从高原迁移至平原(3个月内)的患者中选取68例T2D患者,于2017年8月至10月在内分泌科住院,并使用FreeStyle Libre FGM系统进行连续血糖监测(CGM)14天。在整个研究期间,每天使用酶电极法(中国的Super GL)测量指尖毛细血管血糖,并在空腹和三餐后2小时从扫描探头读取血糖水平。此外,将从扫描探头读取数据与采集指尖毛细血管血之间的时间间隔控制在<5分钟。根据CGM指南评估FGM系统的准确性。随后,采用多元线性回归方法分析影响该系统平均绝对相对差异(MARD)的因素。
Pearson相关性分析显示,指尖血糖水平与扫描血糖水平呈正相关(r = 0.86,P = 0.00)。扫描血糖的汇总MARD为14.28±13.40%。Parker误差分析显示,99.30%的数据对位于A区和B区。根据FreeStyle Libre FGM系统探头佩戴时间,MARD和MARD分别为16.55%和14.35%(P = 1.23,P = 0.22)。多元逐步回归分析显示,当血糖波动最大幅度(LAGE)<5.80 mmol/L时,MARD与血糖无相关性,但当LAGE≥5.80 mmol/L时,MARD与血糖呈负相关。
FreeStyle Libre FGM系统在最近从高原迁移至平原的T2D患者中具有良好的准确性。该系统可能是避免高血细胞比容对最近迁移至平原人群血糖监测影响的理想选择。MARD主要受血糖水平和波动的影响,当血糖波动较小时,系统的准确性较高。在血糖水平波动较大的情况下,扫描血糖水平在极低血糖水平时偏差最大。