Schaller Roland, Feichtner Franz, Köhler Hans, Bodenlenz Manfred, Plank Johannes, Wutte Andrea, Mader Julia K, Ellmerer Martin, Hainisch Reinhard, Pieber Thomas R, Schaupp Lukas
Institute of Medical Technologies and Health Management, Joanneum Research Forschungsgesellschaft mbH, Graz, Austria.
J Diabetes Sci Technol. 2009 Jan;3(1):110-6. doi: 10.1177/193229680900300112.
Intensive insulin therapy reduces mortality and morbidity in critically ill patients but places great demands on medical staff who must take frequent blood samples for the determination of glucose levels. A cost-effective solution to this resourcing problem could be provided by an effective and reliable automated blood sampling (ABS) system suitable for ex vivo glucose determination.
The primary study aim was to compare the performance of a prototype ABS system with a manual reference system over a 30 h sampling period under controlled conditions in humans. Two venous cannulae were inserted to connect the ABS system and the reference system. Blood samples were taken with both systems at 15, 30, and 60 min intervals and analyzed using a Beckman glucose analyzer. During the study, blood glucose levels were altered through four meal ingestions.
The median Pearson coefficient of correlation between manually and automatically withdrawn blood samples was 0.976 (0.953-0.996). The system error was -3.327 ± 5.546% (-6.03-0.49). Through Clark error grid analysis, 420 data pairs were analyzed, showing that 98.6% of the data were in zone A and 1.4% were in zone B. Insulin titration error grid analysis revealed an acceptable treatment in 100% of cases. A 17.5-fold reduction in the occurrence of blood-withdrawal failures through occluded catheters was moreover achieved by the added implementation in the ABS system of a "keep vein open" saline infusion.
Our study showed that the ABS system described provides a user-friendly, reliable automated means for reproducible and accurate blood sampling from a peripheral vein for blood glucose determination and thus represents a promising alternative to frequent manual blood sampling.
强化胰岛素治疗可降低重症患者的死亡率和发病率，但对医护人员要求很高，因为他们必须频繁采集血样以测定血糖水平。一种有效且可靠的适用于体外血糖测定的自动采血（ABS）系统，可能为解决这一资源问题提供一种经济高效的方案。
主要研究目的是在人体受控条件下，比较原型ABS系统与手动参考系统在30小时采样期内的性能。插入两根静脉套管以连接ABS系统和参考系统。两个系统均每隔15、30和60分钟采集血样，并使用贝克曼葡萄糖分析仪进行分析。在研究期间，通过四次进餐改变血糖水平。
手动和自动采集的血样之间的皮尔逊相关系数中位数为0.976（0.953 - 0.996）。系统误差为 -3.327 ± 5.546%（-6.03 - 0.49）。通过克拉克误差网格分析，对420对数据进行了分析，结果显示98.6%的数据位于A区，1.4%的数据位于B区。胰岛素滴定误差网格分析显示100%的病例治疗可接受。此外，通过在ABS系统中增加“保持静脉通畅”生理盐水输注，因导管堵塞导致的采血失败发生率降低了17.5倍。
我们的研究表明，所描述的ABS系统提供了一种用户友好、可靠的自动化方法，可从外周静脉进行可重复且准确的血样采集以测定血糖，因此是频繁手动采血的一种有前景的替代方法。
