Freckmann Guido, Pleus Stefan, Eichenlaub Manuel, Eriksson Boija Elisabet, Fokkert Marion, Hinzmann Rolf, Jendle Johan, Klonoff David C, Makris Konstantinos, Nichols James H, Pemberton John, Selvin Elizabeth, Tran Nam K, Witthauer Lilian, Slingerland Robbert J
IFCC Scientific Division-Working Group on Continuous Glucose Monitoring, Ulm, Germany.
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
J Diabetes Sci Technol. 2025 May 6:19322968251336221. doi: 10.1177/19322968251336221.
While current systems for continuous glucose monitoring (CGM) are safe and effective, there is a high degree of variability between readings within and across CGM systems. In current CGM performance studies, device readings are compared with glucose concentrations obtained with a comparator ("reference") measurement procedure (usually capillary or venous glucose). However, glucose concentrations from capillary and venous samples can systematically differ, often by as much as 5 to 10%. Different comparator methods have shown biases of up to 8%, and comparator devices of the same brand can systematically differ by more than 5%. To address these issues, the Working Group on CGM of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC WG-CGM) recommends standardizing study procedures and the comparator measurement process in CGM performance studies. The majority of IFCC WG-CGM members recommend the use of capillary samples as reference, mainly because CGM readings will then be aligned better with results from self-monitoring of blood glucose (SMBG). Even with factory-calibrated CGM systems, manufacturers require CGM users to perform SMBG in some situations, eg, manual calibration, confirmation of extreme readings, discordance between CGM readings and symptoms of hyper- or hypoglycemia, or intermittent signal loss. Comparator devices should meet defined analytical performance specifications for bias and imprecision. Comparator bias can be reduced by retrospective correction of comparator values based on measurements with a method or materials of higher metrological order. Once manufacturers align CGM readings of their systems with comparator results using standardized procedures, variability across CGM systems will be reduced.
虽然当前的连续血糖监测（CGM）系统安全有效，但不同CGM系统内部以及不同系统之间的读数存在很大差异。在当前的CGM性能研究中，设备读数与通过比较器（“参考”）测量程序获得的血糖浓度（通常是毛细血管或静脉血糖）进行比较。然而，毛细血管和静脉样本的血糖浓度可能会系统性地不同，差异通常高达5%至10%。不同的比较器方法显示偏差高达8%，同一品牌的比较器设备之间的系统性差异可能超过5%。为了解决这些问题，国际临床化学和检验医学联合会（IFCC）的CGM工作组（IFCC WG-CGM）建议在CGM性能研究中规范研究程序和比较器测量过程。IFCC WG-CGM的大多数成员建议使用毛细血管样本作为参考，主要是因为这样CGM读数将与血糖自我监测（SMBG）的结果更好地一致。即使是经过工厂校准的CGM系统，制造商也要求CGM用户在某些情况下进行SMBG，例如手动校准、确认极端读数、CGM读数与高血糖或低血糖症状不一致，或间歇性信号丢失。比较器设备应满足关于偏差和不精密度的既定分析性能规范。可以通过基于具有更高计量等级的方法或材料的测量对比较器值进行回顾性校正来降低比较器偏差。一旦制造商使用标准化程序将其系统的CGM读数与比较器结果对齐，不同CGM系统之间的差异将减小。
