Bonora B, Maran A, Ciciliot S, Avogaro A, Fadini G P
Division of Metabolic Diseases, Department of Medicine, University of Padova, Via Giustiniani, 2, 35128, Padua, Italy.
J Endocrinol Invest. 2016 Dec;39(12):1391-1399. doi: 10.1007/s40618-016-0495-8. Epub 2016 Jun 10.
Continuous glucose monitoring (CGM) is being increasingly used in clinical practice. The flash glucose monitoring (FGM) and CGM are different systems of interstitial glucose recording. We aimed to determine the agreement between the factory-calibrated FGM FreeStyle Libre (FSL) and the gold-standard CGM Dexcom G4 Platinum (DG4P).
We analyzed data from n = 8 outpatients with type 1 diabetes, who wore the FSL and DG4P for up to 14 days during their habitual life. We aligned FSL and DG4P recordings to obtain paired glucose measures. We calculated correlation coefficients, mean absolute relative difference (MARD), percentages in Clarke error grid areas, time spent in hyperglycaemia, target glycaemia, or hypoglycaemia, as well as glucose variability with both sensors. Comparison with self-monitoring of blood glucose (SMBG) was also performed.
Patients varied in terms of age, diabetes duration, and HbA1c (from 5.9 to 9.6 %). In the pooled analysis of 10,020 paired values, there was a good correlation between FSL and DG4P (r = 0.76; MARD = 18.1 ± 14.8 %) with wide variability among patients. The MARD was significantly higher during days 11-14 than in days 1-10, and during hypoglycaemia (19 %), than in normoglycaemia (16 %) or hyperglycaemia (13 %). Average glucose profiles and MARD versus SMBG were similar between the two sensors. Time spent in normo-, hyper-, or hypoglycaemia, and indexes of glucose variability was similarly estimated by the two sensors.
In outpatients with type 1 diabetes, we found good agreement between the FSL and DG4P. No significant difference was detected in the estimation of clinical diagnostic parameters.
连续血糖监测(CGM)在临床实践中的应用日益广泛。闪光血糖监测(FGM)和CGM是不同的组织间液葡萄糖记录系统。我们旨在确定工厂校准的FGM FreeStyle Libre(FSL)与金标准CGM Dexcom G4 Platinum(DG4P)之间的一致性。
我们分析了8例1型糖尿病门诊患者的数据,这些患者在日常生活中佩戴FSL和DG4P长达14天。我们对FSL和DG4P的记录进行比对,以获得配对的血糖测量值。我们计算了相关系数、平均绝对相对差异(MARD)、克拉克误差网格区域的百分比、高血糖、目标血糖或低血糖状态下的时间,以及两个传感器的血糖变异性。还进行了与自我血糖监测(SMBG)的比较。
患者在年龄、糖尿病病程和糖化血红蛋白(HbA1c)方面存在差异(范围为5.9%至9.6%)。在对10,020对配对值的汇总分析中,FSL和DG4P之间存在良好的相关性(r = 0.76;MARD = 18.1 ± 14.8%),患者之间存在较大变异性。MARD在第11 - 14天显著高于第1 - 10天,在低血糖期间(19%)高于正常血糖期间(16%)或高血糖期间(13%)。两个传感器的平均血糖曲线以及与SMBG相比的MARD相似。两个传感器对正常血糖(正常血糖)、高血糖或低血糖状态下的时间以及血糖变异性指标的估计相似。
在1型糖尿病门诊患者中,我们发现FSL和DG4P之间具有良好的一致性。在临床诊断参数的估计中未检测到显著差异。