A Calibration Free Continuous Invasive Sensor Targeted at Glycaemic Control in the ICU

由Van Den Berghe等人的开创性临床研究证明，侵入性光纤连续血糖传感器/监测系统的开发是对临床需求的直接响应。这本书于2001年出版。这项研究表明，当重症监护患者通常经历的高血糖水平通过持续注射胰岛素(严格的血糖控制[TGC])恢复并保持在正常血糖水平时，患者死亡率降低40%，发病率降低37%-46%。发病率的减少反映在病人在重症监护室的住院时间缩短，从而提供了额外的经济利益。在试验中，通过间歇性地密集测量和维持患者的血糖水平--最多每小时--实现了所描述的患者益处。尽管全球ICU社区试图引入TGC，但他们只是放宽了限制(因此减少了益处)，因为在典型的ICU中，每小时监测血糖是不可能实现的，而且人们担心，在血样之间的盲目间隔期间，持续注射胰岛素将使患者陷入低血糖，并带来灾难性的后果。开发一种可提供实时数据的侵入性连续光学血糖传感器/监测仪旨在实现TGC，并最大化患者和经济效益。开发一种基于生命周期的系统，具有无需校准的使用模式，将最大限度地提高市场渗透率，并促进TGC在全球范围内受益。

The development of an invasive fibre optic continuous glucose sensor/monitoring system is in direct response to the clinical need demonstrated by the seminal clinical study of Van Den Berghe et al. which was published in 2001. This study demonstrated that when the elevated glucose levels, usually experienced by Intensive Care Patients, were brought back and held within normal glucose levels by the continuous administration of insulin (Tight Glycaemic Control [TGC]), then patient mortality was reduced by 40% and morbidity by 37-46%. This reduction in morbidity was reflected in a reduction of the patient length of stay in the Intensive Care Unit thus providing additional economic benefits. The patient benefits described were achieved on the trial by intensively measuring and maintaining patient glucose levels intermittently-a maximum of hourly. Although the global ICU community have attempted to introduce TGC they have only introduced with relaxed limits (and hence achieved reduced benefits) because hourly monitoring of glucose in a typical ICU is not achievable and the fear is that during the blind interval between blood samples the adminstration of continuous insulin will push the patient into hypoglcaemia with catastrophic consequences. The development of an invasive continuous optical glucose sensor/monitor that provides real time data is aimed at enabling TGC and maximising patient and economic benefit. The development of a lifetime based system, that has a use model that is calibration free, will maximise market penetration and facilitate TGC benefits globally.