Development of a Fiberless Transflectance Noninvasive Glucose Monitor

无纤维透反射无创血糖监测仪的开发

• 批准号: 8331543
• 负责人: Stevan Kun
• 金额: $ 45.03万
• 依托单位: GROVE INSTRUMENTS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-07-21 至 2014-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8331543
• 关键词: Address; Affect; Blood; Blood Glucose; Blood Glucose Self-Monitoring; Blood Plasma Volume; Blood Volume; Blood capillaries; Centers for Disease Control and Prevention (U.S.); Cephalometry; Characteristics; Clinical; Clinical Data; Clinical Research; Connective Tissue; Cost Savings; Data; Detection; Development; Devices; Diabetes Mellitus; Electronics; Engineering; Epidemic; Fingers; Funding; Glucose; Goals; Grant; Health; Health Care Costs; Healthcare Systems; Hematocrit procedure; Individual; Lasers; Lead; Legal patent; Light; Longevity; Marketing; Measurement; Measures; Mechanics; Methodology; Methods; Microcirculation; Morbidity - disease rate; Movement; Nature; Optics; Outcome; Pain; Painless; Patients; Pattern; Performance; Perfusion; Persons; Phase; Physiological; Population; Positioning Attribute; Process; Public Health; Quality of life; Reperfusion Therapy; Research Project Grants; Skin; Small Business Innovation Research Grant; Techniques; Technology; Testing; Time; Tissues; Variant; Work; absorption; attenuation; base; blood glucose regulation; capillary; commercialization; computerized data processing; cost; design; diabetic; ergonomics; glucose monitor; glycemic control; improved; instrument; meetings; mortality; next generation; patient oriented; prototype; volunteer

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.

描述（由申请人提供）：糖尿病是一个流行病级的公共卫生问题。它对发病率、死亡率和总体医疗费用产生不利影响。众所周知，频繁自我监测血糖 (SMBG) 和良好的血糖控制可以改善成本和结果。 SMBG 没有得到充分的接受，因为当前的技术是痛苦的、需要血液并且成本高昂。因此，迫切需要一种无创血糖仪来消除最佳 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 的无创血糖仪基于使用获得专利的光学 Bridget (OB) 方法实时测量血液中葡萄糖对近红外 (NIR) 光的吸收。之前的 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 NIR 透反射指尖原型仪器开发成个人手持式无创血糖仪，为商业化做好准备。为了实现这一目标，我们有以下具体目标：我们将设计、构建和测试 1) 下一代无光纤光学测量头，该测量头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，可提供生理定位、稳定性和最大灌注，以及 3) 电子和机械模块，以实现 50% 的尺寸减小。其他重要目标包括：1）发展对微循环毛细血管弓的详细而复杂的理解，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) develop a new method to precisely measure plasma volume variation during fingertip reperfusion; 3) 开发先进的信号处理和特征提取技术，以提高血糖测量精度和可重复性，4) 进行试点临床研究并确定新 (GI210) 设备的性能准确性和可重复性。所提出的装置对于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影响。使用胃肠道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。