1 型糖尿病患者中 Freestyle Libre 瞬感葡萄糖监测系统（瞬感 GM）的性能：一项随机交叉试验的次要结局分析。
Performance of the Freestyle Libre flash glucose monitoring (flash GM) system in individuals with type 1 diabetes: A secondary outcome analysis of a randomized crossover trial.
机构信息
Diabetes Research Group, Medical School, Swansea University, Swansea, UK.
Applied Sport, Technology, Exercise and Medicine Research Centre (A-STEM), College of Engineering, Swansea University, Swansea, UK.
出版信息
Diabetes Obes Metab. 2019 Nov;21(11):2505-2512. doi: 10.1111/dom.13835. Epub 2019 Aug 5.
AIMS
The efficacy of flash glucose monitoring (flash GM) systems has been demonstrated by improvements in glycaemia; however, during high rates of glucose flux, the performance of continuous glucose monitoring systems was impaired, as detailed in previous studies. This study aimed to determine the performance of the flash GM system during daily-life glycaemic challenges such as carbohydrate-rich meals, bolus insulin-induced glycaemic disturbances and acute physical exercise in individuals with type 1 diabetes.
MATERIALS AND METHODS
This study comprised four randomized trial visits with alternating pre- and post-exercise bolus insulin doses. Throughout the four 14-hour inpatient phases, 19 participants received three carbohydrate-rich meals and performed moderate-intensity exercise. Venous blood glucose and capillary blood glucose during exercise was compared to interstitial glucose concentrations. Flash GM accuracy was assessed by median absolute relative difference (MARD) (interquartile range [IQR]) using the Bland-Altman method and Clark error grid, as well as according to guidelines for integrated CGM approvals (Class II-510(K)).
RESULTS
The overall MARD (IQR) during inpatient phases was 14.3% (6.9%-22.8%), during hypoglycaemia (≤3.9 mmol/L) was 31.6% (16.2%-46.8%), during euglycaemia (4.0 mmol/L - 9.9 mmol/L) was 16.0% (8.5%-24.0%) and during hyperglycaemia (≥10 mmol/L) was 9.4% (5.1%-15.7%). Overall Bland-Altman analysis showed a bias (95% LoA) of 1.26 mmol/L (-1.67 to 4.19 mmol/L). The overall MARD during acute exercise was 29.8% (17.5%-39.8%), during hypoglycaemia was 45.1% (35.2%-51.1%), during euglycaemia was 30.7% (18.7%-39.2%) and during hyperglycaemia was 16.3% (10.0%-22.8%).
CONCLUSION
Flash GM interstitial glucose readings were not sufficiently accurate within the hypoglycaemic range and during acute exercise and require confirmatory blood glucose measurements.
目的
已证明闪光血糖监测（flash GM）系统通过改善血糖控制来提高疗效；然而，在葡萄糖通量率较高的情况下，连续血糖监测系统的性能受到了损害，这在之前的研究中已有详细说明。本研究旨在确定 flash GM 系统在 1 型糖尿病患者日常生活中的血糖挑战（如富含碳水化合物的膳食、胰岛素冲击引起的血糖波动和急性体育锻炼）期间的性能。
材料与方法
本研究共包括 4 次随机试验访问，交替进行运动前和运动后胰岛素冲击剂量。在 4 个 14 小时的住院阶段中，19 名参与者接受了 3 次富含碳水化合物的膳食并进行了中等强度的运动。比较运动期间的静脉血糖和毛细血管血糖与间质葡萄糖浓度。使用 Bland-Altman 方法和 Clark 误差网格以及根据集成 CGM 批准指南（Class II-510(K)）评估 flash GM 准确性，通过中位数绝对相对差异（MARD）（四分位距 [IQR]）进行评估。
结果
住院期间的总体 MARD（IQR）为 14.3%（6.9%-22.8%），低血糖（≤3.9mmol/L）时为 31.6%（16.2%-46.8%），血糖正常（4.0mmol/L-9.9mmol/L）时为 16.0%（8.5%-24.0%），高血糖（≥10mmol/L）时为 9.4%（5.1%-15.7%）。总体 Bland-Altman 分析显示偏差（95% LoA）为 1.26mmol/L（-1.67 至 4.19mmol/L）。急性运动期间的总体 MARD 为 29.8%（17.5%-39.8%），低血糖时为 45.1%（35.2%-51.1%），血糖正常时为 30.7%（18.7%-39.2%），高血糖时为 16.3%（10.0%-22.8%）。
结论
flash GM 间质葡萄糖读数在低血糖范围和急性运动期间不够准确，需要进行确认性血糖测量。
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