SBIR Phase II: Novel sensor for non-invasive blood glucose monitoring

这个SBIR二期项目将展示一种基于创新的光学传感技术的有前景的连续无创血糖监测方法。到目前为止，还没有任何组织成功地生产出FDA批准的非侵入性血糖仪，即提供与当前自检方法(在试纸上沉积血滴)相当的灵敏度和选择性水平的血糖仪。制造准确仪器的主要困难是可靠地区分人体组织中微弱的葡萄糖信号和固有的干扰效应。牛顿光子学(NP)发展了一种基于光学相干层析成像(OCT)的新方法。研究人员此前已经证明，OCT可以检测一个人的血糖水平。不幸的是，生理效应的相当大的影响，特别是细胞大小、组织水化和组织不均匀的影响，限制了这种模式的实际应用。NP将OCT传感与皮肤的热调制和新的降噪技术相结合，以克服这一关键缺陷。在第一阶段，NP在使用模体和体外组织的实验中演示了操作原理。在第二阶段，NP将升级人体测试系统并进行临床前试验。NP的非侵入性血糖监测器将改善数百万依赖外部血糖水平控制健康的人的生活。NP监视器提供连续的数据输出。它保持了测量的准确性，而无需商业皮下探头所需的频繁校准。这些功能将实现方便、无痛的操作。两组用户将从这项技术中受益：a)医院将改善重症监护患者的健康和寿命，同时降低医疗保健成本。每年约有2000万重症监护病房(ICU)患者经常因大手术或疾病而患上高血糖。2001年的一项里程碑式的医学研究表明，对ICU患者进行严格的血糖控制直接导致住院时间的缩短，并使住院后第一年的死亡率降低3-8%。B)自我检测糖尿病患者将有一种方便、无痛的方法来更频繁地监测他们的血糖水平，从而更准确地控制血糖水平。糖尿病是一种无法治愈的慢性病。2002年，美国治疗糖尿病及其并发症的直接成本为920亿美元，约占美国医疗保健系统年度总成本的10%。

This SBIR Phase II project will demonstrate a promising method for continuous noninvasive glucose monitoring based on an innovative optical sensing technology. To date no organization has been successful in producing an FDA-approved non-invasive glucometer, i.e. one that provides a level of sensitivity and selectivity equivalent to the current self-test method (deposition of a blood droplet on a test strip). The primary difficulty in building an accurate instrument has been the reliable discrimination of the weak glucose signature from interfering effects inherent in live human tissue. Newton Photonics (NP) has developed a new approach based on optical coherence tomography (OCT). Researchers have previously demonstrated that OCT could detect a person's glucose level. Unfortunately, the considerable influence of physiological effects, especially those of cell size, tissue hydration and tissue non-uniformity, have limited the practical application of this modality. NP integrates OCT sensing with thermal modulation of the skin and new noise reduction techniques to overcome this critical deficiency. In Phase I, NP demonstrated the principles of operation in experiments using phantoms and ex-vivo tissue. In Phase-II NP will upgrade the system for human testing and conduct pre-clinical trials.NP's non-invasive glucose monitor will improve the lives of millions of individuals whose health depends on the external control of their glucose levels. The NP monitor provides continuous data output. It maintains its measurement accuracy without the frequent calibration required by commercially available subcutaneous probes. These capabilities will enable convenient, pain-free operation. Two groups of users will benefit from this technology: a) hospitals will improve the health and longevity of intensive care patients while simultaneously reducing the cost of healthcare. Approximately 20 million intensive care unit (ICU) patients per year frequently suffer hyperglycemia as a result of major surgery or illness. A 2001 landmark medical study demonstrated that tight glycemic control of ICU patients leads directly to reduced hospital stay duration and also provides a 3-8% decrease in first year post-hospitalization death rate. b) Self-testing diabetics will have a convenient, painless way to more frequently monitor their glucose level and thus control it more accurately. Diabetes is a chronic disease with no cure. The direct cost of treating diabetes and its complications in the US was $92 billion in 2002, approximately 10% of the entire annual cost of the US healthcare system.