Magarian Peggy, Sterling Bernhard
OptiScan Biomedical Corporation, Hayward, California 94545, USA.
J Diabetes Sci Technol. 2009 Nov 1;3(6):1411-8. doi: 10.1177/193229680900300622.
Four randomized controlled trials have compared mortality and morbidity of tight glycemic control versus conventional glucose for intensive care unit (ICU) patients. Two trials showed a positive outcome. However, one single-center trial and a large multicenter trial had negative results. The positive trials used accurate portable lab analyzers. The negative trial allowed the use of meters. The portable analyzer measures in filtered plasma, minimizing the interference effects. OptiScan Biomedical Corporation is developing a continuous glucose monitor using centrifuged plasma and mid-infrared spectroscopy for use in ICU medicine. The OptiScanner draws approximately 0.1 ml of blood every 15 min and creates a centrifuged plasma sample. Internal quality control minimizes sample preparation error. Interference adjustment using this technique has been presented at the Society of Critical Care Medicine in separate studies since 2006.
A good laboratory practice study was conducted on three Yorkshire pigs using a central venous catheter over 6 h while performing a glucose challenge. Matching Yellow Springs Instrument glucose readings were obtained.
Some 95.7% of the predicted values were in the Clarke Error Grid A zone and 4.3% in the B zone. Of those in the B zone, all were within 3.3% of the A zone boundaries. The coefficient of determination (R(2)) was 0.993. The coefficient of variance was 5.02%. Animal necropsy and blood panels demonstrated safety.
The OptiScanner investigational device performed safely and accurately in an animal model. Human studies using the device will begin soon.
四项随机对照试验比较了重症监护病房（ICU）患者严格血糖控制与传统血糖控制的死亡率和发病率。两项试验显示出积极结果。然而，一项单中心试验和一项大型多中心试验得出了阴性结果。得出阳性结果的试验使用了精确的便携式实验室分析仪。得出阴性结果的试验允许使用血糖仪。便携式分析仪在过滤后的血浆中进行测量，将干扰效应降至最低。OptiScan生物医学公司正在开发一种连续血糖监测仪，该监测仪使用离心后的血浆和中红外光谱技术，用于ICU医学。OptiScanner每15分钟抽取约0.1毫升血液，并创建一个离心后的血浆样本。内部质量控制可将样本制备误差降至最低。自2006年以来，在危重病医学协会的单独研究中介绍了使用该技术进行干扰调整的情况。
对三只约克郡猪进行了一项良好实验室规范研究，在6小时内通过中心静脉导管进行葡萄糖激发试验，同时获取了与之匹配的Yellow Springs Instrument血糖仪读数。
约95.7%的预测值处于克拉克误差网格A区，4.3%处于B区。处于B区的所有数据均在A区边界的3.3%以内。决定系数（R²）为0.993。变异系数为5.02%。动物尸检和血液检测显示该监测仪安全。
OptiScanner研究设备在动物模型中安全、准确地运行。使用该设备的人体研究即将开始。
