Continuous glucose monitoring with glucose sensors: calibration and assessment criteria.
Continuous glucose monitoring with glucose sensors: calibration and assessment criteria.
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DOI：
10.1089/152091503322250596
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发表时间：
2003-01-01
影响因子：
5.4
通讯作者：
Heinemann, Lutz
中科院分区：
文献类型：
--
作者：
Lodwig, Volker;Heinemann, Lutz
通过微创或无创葡萄糖传感器进行连续血糖监测 (CM) 有助于进一步优化糖尿病患者的代谢控制，而无需频繁测量毛细血管血糖。大多数葡萄糖传感器测量间质液 (ISF) 中的葡萄糖浓度。由于该隔室中的条件不同，制造商似乎不可能进行一般的体外校准（=工厂校准）。因此，传感器信号的校准必须由患者自己反复进行。校准过程可以通过传统的毛细血管血糖测量来执行，以便将从特定隔室（例如，ISF）获得的传感器信号转换成“血液”葡萄糖值。许多方面都会影响该程序的有效性。血糖和 ISF 葡萄糖变化在时间和浓度维度上的关系尚不清楚，尤其是在动态变化期间。物理滞后时间主要取决于所使用的葡萄糖传感器技术，也会引入系统校准误差。首次校准（通常在应用给定葡萄糖传感器后数小时进行）后，需要以一定的时间间隔进行重新校准。因此，患者应严格评估 CM 系统显示的值。在葡萄糖值不可信的情况下，他们应该通过传统的毛细血管葡萄糖测量来验证结果。迄今为止，对于用于评估 CM 系统性能和校准质量的评估标准尚未达成共识。现有的根据相应参考值显示 CM 值的方法，包括线性回归分析和误差网格分析，以及系统误差、预测误差平方和（以 % 为单位）和平均绝对偏差等数值标准，通常不适用于 CM。看起来他们似乎不允许对 CM 系统获得的数据进行充分的描述。迫切需要开发新颖的充分评估标准，以便更好地表征 CM 系统性能。如果所有评估 CM 系统的制造商和科学家都统一使用这些数据，就可以对不同系统的性能进行公平的比较。
Continuous glucose monitoring (CM) by means of minimally invasive or noninvasive glucose sensors can help to further optimize metabolic control in patients with diabetes without need for frequent capillary blood glucose measurements. Most glucose sensors measure glucose concentration in the interstitial fluid (ISF). Because of the varying conditions in this compartment, a general in vitro calibration ( = factory calibration) by the manufacturer appears not to be possible. Therefore, calibration of the sensor signal must be performed by the patient himself repeatedly. The calibration procedure can be performed by means of conventional capillary blood glucose measurements in order to transform the sensor signals obtained from the specific compartment (e.g., ISF) into "blood" glucose values. A number of aspects can influence the validity of this procedure. The relationship between changes in blood glucose and in ISF glucose, in both time and concentration dimensions, is not well understood, especially during dynamic changes. The physical lag time, which critically depends on the glucose sensor technology used, can also introduce a systematic calibration error. After the first calibration, usually performed some hours after the application of a given glucose sensor, recalibration at certain intervals is necessary. Therefore, patients should critically assess the values displayed by a CM system. In the case of implausible glucose values they should verify the results by means of a conventional capillary glucose measurement. Up to now there is no consensus on assessment criteria to be used for evaluation of CM system performance and calibration quality. Existing methods of displaying CM values against corresponding reference values, including linear regression analysis and error grid analysis, as well as numeric criteria such as System Error, Predicted Error Sum of Squares (in %), and Mean Absolute Deviation are not generally applicable to CM. It appears as if they do not allow sufficient description of data obtained with CM systems. There is a pressing need to develop novel adequate assessment criteria enabling a better characterization of CM system performance. If these were used uniformly by all manufacturers and scientists assessing CM systems, this would allow a fair comparison of the performance of different systems.