Meng Ran, Gu Tianwei, Yang Fan, Liu Jie, Sun Qichao, Zhu Dalong
Department of Endocrinology, Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital, Nanjing, 210008, China.
Diabetes Ther. 2021 Dec;12(12):3153-3165. doi: 10.1007/s13300-021-01171-2. Epub 2021 Oct 26.
The present study was aimed to evaluate the performance and safety of the Glunovo® real-time continuous glucose monitoring system (CGMS) in monitoring interstitial fluid glucose in adult participants with diabetes (at least 18 years old) using venous blood glucose as control.
This was a multicenter, self-controlled clinical trial, conducted in participants with diabetes from China, between March 2019 to October 2019. The CGMS was used by all the participants for a 14-day wear-in period. The real-time glucose values measured by Glunovo® CGMS were compared with venous blood glucose values measured by the Entwicklung, Konstruktion und Fertigung (EKF) blood glucose detector. The primary outcomes were the consistency rate of CGMS readings and venous blood glucose values (20/20% standard).
A total of 78 participants (41 men, 37 women) and 156 CGMS sensors were included in the study. Among the included participants, 25 and 53 participants had type 1 and type 2 diabetes, respectively, with median age of 52.50 years (range 32-62 years). The overall agreement rate (20/20%) was 89.71% (95% CI 89.18-90.24%). It was observed that 99.08% (95% CI 98.91-99.24%) and 99.82% (95% CI 99.74-99.89%) of the measuring points fell within the A + B zones of the Clarke error grid analysis and Parkes/consensus error grid analysis, respectively. The mean absolute relative difference was 10.30% ± 4.86%. The probability of a glucose measurement falling within a range, when stratified by venous glucose measurements, ranged from 7.14% for 19.44-22.22 mmol/L to 79.21% for 4.44-6.67 mmol/L. There were 73 (41.24%) and 27 (57.45%) successful CGMS alarms for hypoglycemic and hyperglycemic events, respectively.
From the results, Glunovo® CGMS had excellent accuracy and limited clinical risk compared with venous blood glucose in the range of 2.2-22.2 mmol/L over 14 days.
本研究旨在评估Glunovo®实时连续血糖监测系统（CGMS）在以静脉血糖作为对照，监测成年糖尿病患者（至少18岁）组织间液葡萄糖时的性能和安全性。
这是一项多中心、自身对照的临床试验，于2019年3月至2019年10月在中国的糖尿病患者中开展。所有参与者使用CGMS进行为期14天的磨合期。将Glunovo® CGMS测量的实时血糖值与恩特威克托、康斯楚克申与费尔蒂贡（EKF）血糖仪测量的静脉血糖值进行比较。主要结局为CGMS读数与静脉血糖值的一致性率（20/20%标准）。
本研究共纳入78名参与者（41名男性，37名女性）和156个CGMS传感器。在纳入的参与者中，分别有25名和53名参与者患有1型和2型糖尿病，中位年龄为52.50岁（范围32 - 62岁）。总体符合率（20/20%）为89.71%（95%CI 89.18 - 90.24%）。观察到分别有99.08%（95%CI 98.91 - 99.24%）和99.82%（95%CI 99.74 - 99.89%）的测量点落在克拉克误差网格分析和帕克斯/共识误差网格分析的A + B区内。平均绝对相对差异为10.30%±4.86%。按静脉血糖测量分层时，血糖测量值落在某一范围内的概率，在静脉血糖为19.44 - 22.22 mmol/L时为7.14%，在静脉血糖为4.44 - 6.67 mmol/L时为79.21%。低血糖和高血糖事件的CGMS警报分别有73次（41.24%）和27次（57.45%）成功触发。
结果表明，在14天内，Glunovo® CGMS与静脉血糖相比，在2.2 - 22.2 mmol/L范围内具有出色的准确性且临床风险有限。
