Department of Pediatrics, Diabetology, Endocrinology and Nephrology, Medical University of Lodz, Lodz, Poland.
Department of Biostatistics and Translational Medicine, Medical University of Lodz, Lodz, Poland.
Pediatr Diabetes. 2019 Aug;20(5):604-612. doi: 10.1111/pedi.12854. Epub 2019 Apr 17.
We aimed to compare glycemic control and variability parameters obtained from paired records of real-time continuous glucose monitoring (RT-CGM) and flash glucose monitoring (FGM).
Ten Polish boys and 11 girls aged 15.3 ± 2.1 years with type 1 diabetes for 7.7 ± 4.5 years and glycated hemoglobin 7.35 ± 0.7% (57 ± 5 mmol/mol) were recruited between August 2017 and June 2018 and equipped with devices for RT-CGM (iPro2 system with Enlite electrodes) and FGM (FreeStyle Libre) for 1 week. Afterwards, Glyculator 2.0 software was used to calculate and compare key metrics of glycemic control listed in the International Consensus on Use of Continuous Glucose Monitoring, with distinction into all record/night-time/day-time blocks when appropriate.
Agreement between the two systems' measurements across patients ranged from poor (R = .39) to nearly perfect (R = .97). Significant differences between RT-CGM and FGM were observed in five important metrics: coefficient of variation (median difference: -4.12% [25%-75%: -7.50% to -2.96%], P = .0001), low blood glucose index (-0.88 [-1.88 to -0.18], P = .0004), % of time below 70 mg/dL (3.9 mmol/L) (-4.77 [-8.39 to -1.19], P = .0015) and 54 mg/dL (3 mmol/L) (-1.33 [-4.07 to 0.00], P = .0033) and primary time in range (TIR) 70-180 mg/dL (8.58 [1.31 to 12.66], P = .0006).
RT-CGM and FGM differ in their estimates of clinically important indices of glycemic control. Therefore, such metrics cannot be directly compared between people using different systems. Our result necessitates system-specific guidelines and targets if TIR and glycemic variability are to be used as an endpoint in clinical trials.
我们旨在比较实时连续血糖监测(RT-CGM)和闪光血糖监测(FGM)配对记录获得的血糖控制和变异性参数。
2017 年 8 月至 2018 年 6 月期间,招募了 10 名波兰男孩和 11 名年龄为 15.3±2.1 岁、糖尿病病程为 7.7±4.5 年、糖化血红蛋白为 7.35±0.7%(57±5mmol/mol)的 1 型糖尿病患儿,为其配备 RT-CGM(iPro2 系统与 Enlite 电极)和 FGM(FreeStyle Libre)设备,佩戴时长为 1 周。随后,使用 Glyculator 2.0 软件计算并比较国际连续血糖监测使用共识中列出的血糖控制关键指标,并在适当情况下区分所有记录/夜间/日间时间段。
患者两种系统测量值之间的一致性范围从较差(R=0.39)到几乎完美(R=0.97)。在五个重要指标中,RT-CGM 和 FGM 之间存在显著差异:变异系数(中位数差异:-4.12%[25%-75%:-7.50%至-2.96%],P=0.0001)、低血糖指数(-0.88[-1.88 至-0.18],P=0.0004)、低于 70mg/dL(3.9mmol/L)的时间百分比(-4.77[-8.39 至-1.19],P=0.0015)和 54mg/dL(3mmol/L)(-1.33[-4.07 至 0.00],P=0.0033)和血糖 70-180mg/dL(8.58[1.31 至 12.66],P=0.0006)的时间比例。
RT-CGM 和 FGM 在评估血糖控制的临床重要指标方面存在差异。因此,不能直接比较使用不同系统的人群之间的此类指标。如果 TIR 和血糖变异性要作为临床试验的终点,那么我们的研究结果需要针对特定系统制定指南和目标。