【摘要】 目的 评价三诺爱看（Sinocare iCan）i3型和H3型持续葡萄糖监测（CGM）系统应用于成年DM患者BG监测的安全性和有效性。方法 选取2022年1月至4月于北京大学人民医院、中南大学湘雅二医院和北京市平谷医院诊治的≥18岁DM患者120例，分为居家佩戴三诺爱看i3型的i3组和住院佩戴H3型的H3组，每组60例，以Yellow Spring Instrument生化分析仪为对照器械进行比较，评价其有效性与安全性。结果 两组一般资料比较，差异无统计学意义（P>0.05）。i3、H3组与参考值的20/20%一致性（93.65%、95.81%）、测量点落在Clarke误差栅格A+B区比例（99.22%、100.00%）、测量点落在Consensus误差栅格A+B区比例（100.00%、100.00%）、平均相对误差绝对值（8.71%、7.45%）均符合标准。i3、H3组高血糖阈值提醒成功率为90.19%、96.52%，检测成功率为96.06%、96.66%，低血糖阈值提醒成功率为79.44%、80.33%，检测成功率为96.23%、100.00%。易用性评价显示，两组>90%患者对使用的便捷性和佩戴舒适感评价较高，>85%表示传感器附着无痛感，研究过程中监测仪器提前取下或脱落6例，i3组发生不良事件25例次，H3组发生不良事件8例次，未发生与仪器相关的不良事件及严重不良事件。结论 三诺爱看i3型和H3型CGM系统具有良好的有效性和安全性。更多还原

【Abstract】 Objective To evaluate the safety and efficacy of the Sinocare iCan i3 and H3 continuous glucose monitoring(CGM) systems in monitoring blood glucose levels in adult patients with diabetes mellitus(DM). Methods A total of 120 DM patients aged 18 years or above who were treated at Peking University People’s Hospital,The Second Xiangya Hospital of Central South University,and Pinggu Hospital of Beijing from January to April 2022 were selected. They were divided into the i3 group(wearing Sinocare iCan i3 type at home) and the H3 group(wearing Sinocare iCan H3 type during hospitalization),with 60 cases in each group. The effectiveness and safety of the devices were evaluated by comparing with the Yellow Spring Instrument biochemical analyzer as the control instrument. Results There was no statistically significant difference in the general data of the two groups(P>0. 05). The the reference values 20/20% consistency(93. 65%, 95. 81%),the rate of measurement points falling within the Clarke error grid A+B area(99. 22%, 100. 00%),the rate of measurement points falling within the Consensus error grid A+B area(100. 00%,100. 00%),and the mean absolute relative error(8. 71%, 7. 45%) all met the standards between i3,H3 groups. The true alert rate of high blood glucose threshold reminder in i3,H3 groups was 90. 19% and 96. 52%,the correct detection rate was 96. 06% and 96. 66%,the true alert rate of low blood glucose threshold reminder was 79. 44% and 80. 33%,and the correct detection rate was 96. 23% and 100. 00%. The usability evaluation showed that more than 90% of the patients in both groups rated the convenience of use and the wearing comfort as high,and more than 85% reported no pain during sensor attachment. During the study,6 cases of premature removal or detachment of the monitoring instrument occurred,with 25 cases of adverse events in the i3 group and 8 cases in the H3 group. No adverse events related to the instrument or serious adverse events occurred. Conclusions The Sinocare iCan i3 and H3 types of CGM systems devices have excellent effectiveness and safety.更多还原