Wen Xiaofang, Zeng Nan, Zhang Ningbo, Ou Tingting, Li Xiaowei, Li Xiaoying, Li Wangen, Xu Kang, Du Tao
Department of Endocrinology, The Second Affiliated Hospital, Guangzhou Medical University, Guangzhou, 510260, People's Republic of China.
Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen, 518036, People's Republic of China.
Diabetes Metab Syndr Obes. 2022 Nov 3;15:3437-3445. doi: 10.2147/DMSO.S381565. eCollection 2022.
Although flash continuous glucose monitoring systems (FCGM) accuracy has been extensively studied in diabetes, its accuracy is still not fully evaluated in type 2 diabetes (T2D) patients in real-world settings. In the present study, we aim to assess the effects of diabetes complications and related comorbidities on FCGM accuracy in T2D patients with diabetes complications and related comorbidities in the real world.
FCGM data were collected at eight-time points daily (3 AM, 7 AM, 9 AM, 11 AM, 1 PM, 5 PM, 7 PM, and 9 PM) from 742 patients with T2D and compared with simultaneous fingertip capillary blood glucose (reference blood glucose, REF), and the difference was evaluated using Parkes error grid (PEG), surveillance error grid (SEG), and logistic regression analysis.
In total, 25,579 FCGM/REF data pairs were included in the study. The FCGM values were lower than the paired REF values in 75% of the pairs. The maximum bias (-23.0%) and maximum mean absolute relative difference (24.5%) were observed at 3 AM among eight-time points. SEG analysis also demonstrated the highest percentage of paired readings in moderate and great risk zone (C and D) at 3 AM than PEG analysis (7.33% vs 0.43%, <0.001). According to the SEG classification, hypoglycemia, infection, diabetic foot, diabetic ketoacidosis, and hypertension were independent risk factors that impaired FCGM accuracy in patients.
FCGM commonly underestimates blood glucose levels. Compared with PEG, SEG analysis seems more conducive to the analysis of FCGM performance. The present data highlights the impairment of diabetes complications and related comorbidities on the FCGM accuracy in T2D patients.
尽管闪光连续血糖监测系统（FCGM）的准确性已在糖尿病领域得到广泛研究，但在现实环境中，其在2型糖尿病（T2D）患者中的准确性仍未得到充分评估。在本研究中，我们旨在评估糖尿病并发症及相关合并症对现实世界中患有糖尿病并发症及相关合并症的T2D患者FCGM准确性的影响。
从742例T2D患者中每日8个时间点（凌晨3点、上午7点、上午9点、上午11点、下午1点、下午5点、晚上7点和晚上9点）收集FCGM数据，并与同时采集的指尖毛细血管血糖（参考血糖，REF）进行比较，使用帕克斯误差网格（PEG）、监测误差网格（SEG）和逻辑回归分析评估差异。
本研究共纳入25,579对FCGM/REF数据。75%的配对中FCGM值低于配对的REF值。在八个时间点中，凌晨3点观察到最大偏差（-23.0%）和最大平均绝对相对差异（24.5%）。SEG分析还显示，凌晨3点时中度和高风险区（C和D）的配对读数百分比高于PEG分析（7.33%对0.43%，<0.001）。根据SEG分类，低血糖、感染、糖尿病足、糖尿病酮症酸中毒和高血压是损害患者FCGM准确性的独立危险因素。
FCGM通常低估血糖水平。与PEG相比，SEG分析似乎更有利于分析FCGM性能。本数据突出了糖尿病并发症及相关合并症对T2D患者FCGM准确性的损害。
