Freckmann Guido, Link Manuela, Kamecke Ulrike, Haug Cornelia, Baumgartner Bernhard, Weitgasser Raimund
1 Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
2 Abteilung für Innere Medizin / Kompetenzzentrum Diabetes, Privatklinik Wehrle-Diakonissen, Salzburg, Austria.
J Diabetes Sci Technol. 2019 Sep;13(5):890-898. doi: 10.1177/1932296819826965. Epub 2019 Feb 7.
To be able to compare continuous glucose monitoring (CGM) systems, they have to be worn in parallel by the same subjects. This study evaluated the performance and usability of three different CGM systems in direct comparison.
In this open, prospective study at two sites, 54 patients with diabetes wore three CGM systems each (Dexcom G5™ Mobile CGM system [DG5], Guardian™ Connect system [GC], and a Roche CGM system [RCGM]) in parallel for 6 or 7 days in a mixed inpatient and outpatient setting. Capillary comparison measurements were performed using a self-monitoring of blood glucose (SMBG) system. During study site visits, glucose excursions were induced. Performance of the systems was evaluated by calculating mean absolute relative differences (MARD, calculated as absolute differences for glucose concentrations <100 mg/dL and as relative differences for glucose concentrations ≥100 mg/dL), and mean relative differences (MRD, bias) between CGM and SMBG results. In addition, usability of the systems was assessed.
Overall MARD was 10.1 ± 2.1 for DG5, 11.5 ± 4.2 for GC, and 11.9 ± 5.6 for RCGM. Performance improved in all systems after the first day of use. All systems showed >99% of values within zones A and B of the consensus error grid. Overall, all CGM systems showed a small negative bias compared to SMBG. Usability of the systems differed regarding patch adhesion rate, failure rate, and patient rating. Most patients preferred GC, but in general all systems were rated positively.
All three CGM systems showed similar overall accuracy in this direct comparison, but small differences were observed with regard to specific glucose ranges and usability aspects.
为了能够比较连续血糖监测（CGM）系统，必须让同一受试者同时佩戴这些系统。本研究直接比较了三种不同CGM系统的性能和可用性。
在两个地点进行的这项开放性前瞻性研究中，54例糖尿病患者在住院和门诊混合环境中，每人同时佩戴三种CGM系统（德康G5™移动CGM系统[DG5]、佳腾™ Connect系统[GC]和罗氏CGM系统[RCGM]）6或7天。使用血糖仪进行毛细血管对比测量。在研究站点访视期间，诱发血糖波动。通过计算平均绝对相对差异（MARD，血糖浓度<100mg/dL时计算为绝对差异，血糖浓度≥100mg/dL时计算为相对差异）以及CGM与血糖仪测量结果之间的平均相对差异（MRD，偏差）来评估系统性能。此外，还评估了系统的可用性。
DG5的总体MARD为10.1±2.1，GC为11.5±4.2，RCGM为11.9±5.6。使用第一天后，所有系统的性能均有所改善。所有系统在共识误差网格的A区和B区内的值均>99%。总体而言，与血糖仪相比，所有CGM系统均显示出较小的负偏差。各系统在贴片粘贴率、故障率和患者评分方面的可用性存在差异。大多数患者更喜欢GC，但总体而言，所有系统的评分均为正面。
在这次直接比较中，所有三种CGM系统的总体准确性相似，但在特定血糖范围和可用性方面存在细微差异。
