Development of a Fiberless Transflectance Noninvasive Glucose Monitor

描述（由申请人提供）：糖尿病是一种流行的公共卫生问题。它对发病率、死亡率和总体医疗保健成本产生不利影响。众所周知，频繁的自我血糖监测（SMBG）和良好的血糖控制可以改善成本和结果。SMBG没有被充分接受，因为目前的技术是痛苦的，需要血液，而且成本很高。因此，迫切需要一种无创血糖仪，消除达到最佳SMBG的所有障碍。Grove Instruments （GI，前身为VivaScan）开发了无创血糖测量技术，可以满足迅速增长的糖尿病人群的需求。GI的无创血糖仪是基于实时测量近红外（NIR）光吸收血液中的葡萄糖使用专利光学桥（OB）方法。以前的SBIR拨款和私人公司资金使GI能够开发和临床测试先进的工程原型手持式无创血糖仪。Grove目前的目标是将我们的近红外透射指尖原型仪器发展成为个人手持式无创血糖仪，准备商业化。为了实现这一目标，我们有这些具体的目标：我们将设计、制造和测试1)下一代无纤维光学测量头，它对激光二极管和其他光学元件的对准不敏感，并且可以低成本批量生产2)一种新的符合人体工程学的手指端口，提供生理定位、稳定性和最大灌注，以及3)电子和机械模块，以实现50%的尺寸缩小。其他重要目标包括：1)发展对微循环毛细血管拱廊的详细和复杂的理解，以改进测量过程中微循环血容量变化模式的检测和量化；2)建立一种精确测量指尖再灌注过程中血浆容量变化的新方法；3)开发先进的信号处理和特征提取技术，以提高葡萄糖测量的精度和可重复性；4)开展临床试验，确定新型（GI210）设备的性能准确性和可重复性。该装置对糖尿病患者的血糖控制质量、生活质量和寿命具有重要意义。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。

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.