Moser Othmar, Sternad Christoph, Eckstein Max L, Szadkowska Agnieszka, Michalak Arkadiusz, Mader Julia K, Ziko Haris, Elsayed Hesham, Aberer Felix, Sola-Gazagnes Agnes, Larger Etienne, Fadini Gian Poalo, Bonora Benedetta Maria, Bruttomesso Daniela, Boscari Federico, Freckmann Guido, Pleus Stefan, Christiansen Sverre C, Sourij Harald
Division of Exercise Physiology and Metabolism, Institute of Sport Science, University of Bayreuth, Bayreuth, Germany.
Interdisciplinary Metabolic Medicine Trials Unit, Medical University of Graz, Graz.
Diabetes Obes Metab. 2022 Mar;24(3):522-529. doi: 10.1111/dom.14609. Epub 2021 Dec 19.
To conduct a pooled analysis to assess the performance of intermittently scanned continuous glucose monitoring (isCGM) in association with the rate of change in sensor glucose in a cohort of children, adolescents, and adults with type 1 diabetes.
In this pooled analysis, isCGM system accuracy was assessed depending on the rate of change in sensor glucose. Clinical studies that have been investigating isCGM accuracy against blood glucose, accompanied with collection time points were included in this analysis. isCGM performance was assessed by means of median absolute relative difference (MedARD), Parkes error grid (PEG) and Bland-Altman plot analyses.
Twelve studies comprising 311 participants were included, with a total of 15 837 paired measurements. The overall MedARD (interquartile range) was 12.7% (5.9-23.5) and MedARD differed significantly based on the rate of change in glucose (P < 0.001). An absolute difference of -22 mg/dL (-1.2 mmol/L) (95% limits of agreement [LoA] 60 mg/dL (3.3 mmol/L), -103 mg/dL (-5.7 mmol/L)) was found when glucose was rapidly increasing (isCGM glucose minus reference blood glucose), while a -32 mg/dL (1.8 mmol/L) (95% LoA 116 mg/dL (6.4 mmol/L), -51 mg/dL (-2.8 mmol/L)) absolute difference was observed in periods of rapidly decreasing glucose.
The performance of isCGM was good when compared to reference blood glucose measurements. The rate of change in glucose for both increasing and decreasing glucose levels diminished isCGM performance, showing lower accuracy during high rates of glucose change.
进行一项汇总分析，以评估间歇性扫描式动态血糖监测（isCGM）在1型糖尿病儿童、青少年和成人队列中与传感器葡萄糖变化率相关的性能。
在这项汇总分析中，根据传感器葡萄糖的变化率评估isCGM系统的准确性。本分析纳入了针对动态血糖监测与血糖准确性进行研究并伴有采集时间点的临床研究。通过中位数绝对相对差异（MedARD）、帕克斯误差网格（PEG）和布兰德-奥特曼图分析来评估isCGM的性能。
纳入了12项研究，共311名参与者，总计15837对测量值。总体MedARD（四分位间距）为12.7%（5.9 - 23.5），且MedARD根据葡萄糖变化率存在显著差异（P < 0.001）。当葡萄糖快速上升时（isCGM葡萄糖减去参考血糖），发现绝对差异为 -22 mg/dL（-1.2 mmol/L）（95%一致性界限[LoA]为60 mg/dL（3.3 mmol/L），-103 mg/dL（-5.7 mmol/L）），而在葡萄糖快速下降期间观察到的绝对差异为 -32 mg/dL（-1.8 mmol/L）（95% LoA为116 mg/dL（6.4 mmol/L），-51 mg/dL（-2.8 mmol/L））。
与参考血糖测量值相比，isCGM的性能良好。葡萄糖上升和下降水平时的葡萄糖变化率均会降低isCGM的性能，在高葡萄糖变化率期间准确性较低。
