Mondal Shaikat, Mondal Himel, Biri Sairavi Kiran
Department of Physiology, Raiganj Government Medical College and Hospital, Raiganj, West Bengal, India.
Department of Physiology, Bhima Bhoi Medical College and Hospital, Balangir, Odisha, India.
Indian J Endocrinol Metab. 2020 Mar-Apr;24(2):181-186. doi: 10.4103/ijem.IJEM_580_19. Epub 2020 Apr 30.
Along with stand-alone glucose monitors, smartphone-dependent glucose meters (SDGM) are available for self-monitoring of blood glucose (SMBG). These display-less devices, connected to a smartphone, measure glucose and display report on a smartphone screen, which can be easily shared with doctors.
The aim of this study was to check the accuracy of the available SDGMs in relation to the laboratory reference method.
Two available SDGMs: BeatO™ and GlucoMe™ were tested. A total of 104 venous blood samples were tested for glucose in SDGMs and by the reference method. The accuracy of the report was checked by the International Standards Organization (ISO), American Diabetes Association (ADA), and Clinical Laboratory Improvement Amendments (CLIA) criteria. Clarke error grid analysis (CEGA) was carried out to find the suitability of SDGM in clinical usage.
Mean plasma glucose ( = 104) level from laboratory report was 106.48 ± 44.58 mg/dL, that from BeatO™ was 105.78 ± 52.6, and GlucoMe™ was 99.72 ± 51.22. The accuracy was lower than that recommended by ISO 2013 (29.8% and 30.77% error in BeatO™ and GlucoMe™, respectively), ADA (63.46% and 74% error in BeatO™ and GlucoMe™, respectively), and CLIA (42.31% and 46.15% error in BeatO™ and GlucoMe™, respectively) criteria. According to CEGA, BeatO™ and GlucoMe™ can guide correct treatment in diabetes mellitus patients for 74% and 71% of measurement, respectively.
The accuracy of both the SDGMs was lower than that suggested by ISO, ADA, and CLIA criteria. The result of this study would help patients and doctors in informed choice for the procurement of glucose monitors.
除了独立的血糖仪外,依赖智能手机的血糖仪(SDGM)也可用于自我血糖监测(SMBG)。这些无显示屏的设备与智能手机相连,可测量血糖并在智能手机屏幕上显示报告,该报告可轻松与医生共享。
本研究的目的是检验现有SDGM相对于实验室参考方法的准确性。
测试了两种现有的SDGM:BeatO™ 和GlucoMe™。共对104份静脉血样本进行了SDGM血糖检测和参考方法检测。报告的准确性按照国际标准化组织(ISO)、美国糖尿病协会(ADA)和临床实验室改进修正案(CLIA)标准进行检查。进行了克拉克误差网格分析(CEGA)以确定SDGM在临床使用中的适用性。
实验室报告的平均血浆葡萄糖水平(n = 104)为106.48±44.58mg/dL,BeatO™ 测得的为105.78±52.6,GlucoMe™ 测得的为99.72±51.22。其准确性低于ISO 2013推荐的标准(BeatO™ 和GlucoMe™ 的误差分别为29.8%和30.77%)、ADA标准(BeatO™ 和GlucoMe™ 的误差分别为63.46%和74%)以及CLIA标准(BeatO™ 和GlucoMe™ 的误差分别为42.31%和46.15%)。根据CEGA,BeatO™ 和GlucoMe™ 分别能在74%和71%的测量中指导糖尿病患者的正确治疗。
两种SDGM的准确性均低于ISO、ADA和CLIA标准所建议的水平。本研究结果将有助于患者和医生在购买血糖仪时做出明智的选择。