Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China.
Department of Endocrinology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.
J Diabetes. 2022 Jul;14(7):476-484. doi: 10.1111/1753-0407.13296. Epub 2022 Jul 21.
Continuous glucose monitoring systems have been widely used but discrepancies among various brands of devices are rarely discussed. This study aimed to explore differences in glycemic metrics between FreeStyle Libre (FSL) and iPro2 among adults with type 1 diabetes mellitus (T1DM).
Participants with T1DM and glycosylated hemoglobin of 7%-10% were included and wore FSL and iPro2 for 2 weeks simultaneously. Datasets collected on the insertion and detachment day, and those with insufficient quantity (<90%) were excluded. Agreements of measurement accuracy and glycemic metrics were evaluated.
A total of 40 498 paired data were included. Compared with the values from FSL, significantly higher median value was observed in iPro2 (147.6 [106.2, 192.6] vs. 144.0 [100.8, 192.6] mg/dl, p < 0.001) and the largest discordance was observed in hypoglycemic range (median absolute relative difference with iPro2 as reference value: 25.8% [10.8%, 42.1%]). Furthermore, significant differences in glycemic metrics between iPro2 and FSL were also observed in time in range (TIR) 70-180 mg/dl (TIR, 62.8 ± 12.4% vs. 58.8 ± 12.3%, p = 0.004), time spent below 70 mg/dl (4.4 [1.8, 10.9]% vs. 7.2 [5.4, 13.3]%, p < 0.001), time spent below 54 mg/dl (0.9 [0.3, 4.0]% vs. 2.6 [1.3, 5.6]%, p = 0.011), and coefficient of variation (CV, 38.7 ± 8.5% vs. 40.9 ± 9.3%, p = 0.017).
During 14 days of use, FSL and iPro2 provided different estimations on TIR, CV, and hypoglycemia-related parameters, which needs to be considered when making clinical decisions and clinical trial designs.
连续血糖监测系统已被广泛应用，但各品牌设备之间的差异却鲜有报道。本研究旨在探讨 1 型糖尿病患者使用 FreeStyle Libre（FSL）和 iPro2 时血糖指标的差异。
纳入糖化血红蛋白 7%-10%的 1 型糖尿病患者，同时佩戴 FSL 和 iPro2 两周。剔除插入和移除当天以及数据量不足（<90%）的数据集。评估两种设备测量准确性和血糖指标的一致性。
共纳入 40498 对配对数据。与 FSL 相比，iPro2 的中位值明显更高（147.6 [106.2, 192.6] vs. 144.0 [100.8, 192.6] mg/dl，p<0.001），且低值范围的差异最大（以 iPro2 为参考值的中位绝对相对差异：25.8% [10.8%, 42.1%]）。此外，iPro2 与 FSL 的血糖指标在 70-180mg/dl 时间范围内（TIR，62.8 ± 12.4% vs. 58.8 ± 12.3%，p=0.004）、血糖低于 70mg/dl 的时间（4.4 [1.8, 10.9]% vs. 7.2 [5.4, 13.3]%，p<0.001）、血糖低于 54mg/dl 的时间（0.9 [0.3, 4.0]% vs. 2.6 [1.3, 5.6]%，p=0.011）和变异系数（CV，38.7 ± 8.5% vs. 40.9 ± 9.3%，p=0.017）方面均存在显著差异。
在 14 天的使用过程中，FSL 和 iPro2 对 TIR、CV 和低血糖相关参数的估计存在差异，在进行临床决策和临床试验设计时需要考虑这些差异。
