Development of a Fiberless Transflectance Noninvasive Glucose Monitor

描述(申请人提供)：糖尿病是一种流行程度的公共卫生问题。它会对发病率、死亡率和整体医疗成本产生不利影响。众所周知，频繁的血糖自我监测(SMBG)和良好的血糖控制可以提高成本和结果。SMBG没有得到充分的接受，因为目前的技术很痛苦，需要流血，而且成本可能很高。因此，迫切需要一种非侵入性血糖仪，消除最佳SMBG的所有障碍。格罗夫仪器公司(GI，前身为VivaScan)开发了非侵入性血糖测量技术，可以满足迅速增长的糖尿病人群的需求。GI的非侵入性血糖仪是基于使用专利光桥(OB)方法实时测量血液中葡萄糖对近红外线(NIR)光的吸收。之前的SBIR赠款和私人公司的资金使GI能够开发和临床测试一种先进的工程原型，手持非侵入性血糖仪。格罗夫目前的目标是将我们的近红外透射式指尖原型仪器开发成准备商业化的个人手持非侵入性血糖仪。为了实现这一目标，我们有以下具体目标：1)设计、制造和测试1)对激光二极管和其他光学组件的对准不敏感并可低成本批量生产的新一代无光纤光学测量头；2)提供生理定位、稳定性和最大血流灌注的新的人体工程学手指端口；以及3)电子和机械模块，以实现50%的尺寸缩减。其他重要目标包括：1)对微循环毛细血管弓有详细而精密的了解，以完善测量过程中微循环血容量变化模式的检测和量化；2)开发一种新的方法，精确测量指尖再灌注期间的血浆容量变化；3)开发先进的信号处理和特征提取技术，以提高血糖测量的精确度和重复性；4)进行试验性临床研究，并确定新型(GI210)仪器的性能、准确性和重复性。建议的设备对糖尿病患者的血糖控制质量、他们的生活质量和寿命具有重大意义。使用GI无创指尖血糖仪优化SMBG可以改善临床结果，并为糖尿病患者和整个医疗保健系统节省大量成本。 与公众健康相关：格罗夫仪器公司打算通过将一种完全无创、无血、无痛的血糖仪推向市场，从而促进良好的血糖控制的好处，该血糖仪使所有糖尿病患者都能以最佳方式测试他们的血糖，从而改善他们的血糖控制。现有的手指穿刺式血糖仪并没有被常规使用，因为它们很痛，也不方便。Grove的个人非侵入性血糖仪将使糖尿病患者能够在不感到不适或增加成本的情况下进行任意频率的测试，帮助他们改善血糖控制和数百万人的健康，同时降低与糖尿病相关的医疗成本。

DESCRIPTION (provided by applicant): Diabetes is a public health problem of epidemic proportions. It adversely affects morbidity, mortality, and overall healthcare costs. It is well known that frequent self-monitoring of blood glucose (SMBG) and good glycemic control can improve both cost and outcome. SMBG is not adequately embraced because current technology is painful, requires blood, and can be costly. Thus there is an urgent need for a noninvasive blood glucometer that removes all of the impediments to optimal SMBG. Grove Instruments (GI, formerly VivaScan) has developed noninvasive glucose measurement technology that can meet the needs of the burgeoning diabetes population. GI's noninvasive blood glucometer is based on real-time measurements of near-infrared (NIR) light absorption by glucose in blood using a patented Optical Bridget (OB) method. Previous SBIR grants and private company funds have enabled GI to develop and clinically test an advanced engineering prototype handheld noninvasive blood glucometer. Grove's current objective is to develop our NIR transflectance fingertip prototype instrument into a personal handheld noninvasive glucometer ready for commercialization. To achieve this goal we have these specific aims: we will design, build and test 1) a next generation fiberless optical measurement head that is insensitive to alignment of laser diodes and other optical components and is mass-manufacturable at low cost 2) a new ergonomic finger port that provides for physiologic positioning, stability and maximal perfusion, and 3) electronic and mechanical modules to achieve 50% size reduction. Other important aims include: 1) development of a detailed and sophisticated understanding of the microcirculatory capillary arcades to refine detection and quantification of microcirculatory blood volume variation patterns during measurement; 2) develop a new method to precisely measure plasma volume variation during fingertip reperfusion; 3) develop advanced signal processing and feature extraction techniques to improve glucose measurement precision and repeatability, and 4) perform pilot clinical studies and determine the performance accuracy and repeatability of the new (GI210) device. The proposed device has dramatic implications for the quality of glucose control for diabetic persons, their quality of life and longevity. Optimizing SMBG with the GI noninvasive fingertip glucometer can lead to improved clinical outcomes and substantial cost savings to the diabetic individual and to the entire health care system. PUBLIC HEALTH RELEVANCE: Grove Instruments intends to promote the benefits of good glycemic control by bringing to market a completely noninvasive, bloodless, and painless glucometer that allows all people with diabetes to test their blood sugar optimally and thus improve their glycemic control. Existing finger prick glucometers are not being used routinely because they are painful and inconvenient. Grove's personal noninvasive glucometer will enable diabetic persons to test as frequently as desired without discomfort or increased cost helping them improve their glycemic control and the health of millions while reducing health care costs associated with diabetes.