Development of an Advanced Handheld Noninvasive Glucometer

先进手持式无创血糖仪的开发

• 批准号: 7670013
• 负责人: Stevan Kun
• 金额: $ 17.43万
• 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 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7670013
• 关键词: Advanced Development; Affect; Algorithms; American; Applications Grants; Back; Biological; Blood; Blood Glucose; Blood specimen; Cephalometry; Clinical; Collection; Cost Savings; Data; Development; Device or Instrument Development; Devices; Diabetes Mellitus; Diagnosis; Disadvantaged; Disease; Ear; Electronics; Equilibrium; FDA approved; Fiber; Fiber Optics; Fingers; Funding; Generations; Glucose; Goals; Grant; Hand; Health; Healthcare Systems; Hemoglobin; Housing; Individual; Label; Laboratories; Lasers; Lead; Legal patent; Light; Longevity; Marketing; Measurement; Measures; Methodology; Methods; Modification; Morphologic artifacts; Motion; Noise; Non-Insulin-Dependent Diabetes Mellitus; Operative Surgical Procedures; Optics; Outcome; Output; Pain; Pain-Free; Patients; Performance; Personal Computers; Persons; Phase; Pilot Projects; Plug-in; Positioning Attribute; Price; Procedures; Public Health; Quality of life; Recommendation; Reporting; Safety; Sampling; Scanning; Series; Signal Transduction; Site; Sleep; Small Business Innovation Research Grant; Source; Staging; Structure; Surface; System; Techniques; Technology; Testing; Thick; Time; Tissue Sample; Tissues; United States; United States National Institutes of Health; Variant; Water; Work; Writing; absorption; base; blood glucose regulation; commercialization; computer data analysis; computerized data processing; cost; design; detector; diabetes control; diabetic; ergonomics; glucose monitor; glycemic control; imprint; improved; instrument; light transmission; meetings; monitoring device; novel; optical fiber; prevent; programs; prototype; public health relevance; sensor; software systems; transmission process; usability; visual feedback; volunteer

DESCRIPTION (provided by applicant): VivaScan intends to promote the benefits of good glycemic control by bringing to market a completely noninvasive and bloodless, glucometer that will give people with diabetes a pain-free way to test their blood sugar. VivaScan has developed a noninvasive blood glucose monitor, based on measurements of near- infrared (NIR) light absorption in tissue. Our technology utilizes a patented Optical BridgeT (OB) method, which is the optical equivalent of the well-known electrical Wheatstone bridge. The OB measures the variation of differential optical absorption of the sample at two wavelengths to "null out" the large water and background absorption, providing a "cleaner" glucose absorption signal with a signal enhancement in the order of ~1500. SBIR grant and company funds have enabled VivaScan to develop and successfully test VS191 - an advanced laboratory prototype handheld noninvasive blood glucose monitor. The device employs a fiber optic bundle to noninvasively measure blood glucose. During a measurement that lasts ~20 seconds, the finger is placed into the instrument, gently squeezed, light is shone at the finger tip, its blood content modulated and the transflected (backscattered) light is measured and recorded. Our recent patient studies on 10 volunteers produced 450 data pairs with an average absolute prediction error of 12% and 100% of the measurement data in the clinically acceptable A and B zones of the Clarke error grid (84% within 120% error). Four factors associated with the fiber optic bundle limit the development of an affordable, compact and robust hand held noninvasive glucometer. The fiber optic bundle: 1) has a low light transmission efficiency (~8%) resulting in a low measurement signal to noise ratio; 2) is expensive (~$1300); 3) requires a large (10 x 4 cm) space inside the device; and 4) requires a precise movable carriage assembly. The objective of this Phase I project is to develop and test the feasibility of a new device without optical fiber bundles which noninvasively determines blood glucose by transflectance (backscattering) optical measurements. Successful completion of the specific aims for this proposal will result in a device that provides more efficient operation, improved accuracy, significantly less expensive manufacturing costs and a more compact light generation/collection module. The aims for the proposed SBIR Phase I Application project include: 1) Design, build and test a fiberless measurement head; 2) Build a VS193 fiberless handheld noninvasive blood glucose monitor; 3) Perform in-house patient pilot studies to test and validate the VS193 performance. The Phase II work would develop and test a fully functional compact, affordable, and noninvasive glucometer. The proposed device has dramatic implications for the quality of glucose control for diabetic persons, but more importantly, for their quality of life and longevity. Optimizing glucose testing with the VivaScan device can lead to improved clinical outcomes and substantial cost savings to the individual patient and to the entire health care system. PUBLIC HEALTH RELEVANCE: Diabetes is a miserable disease and a serious public health problem, affecting more than 20.8 million people in the United States today. The NIH Diabetes Control & Complications Trial provided compelling evidence that frequent blood-glucose monitoring (more than 4 times a day) and tight blood-glucose control offer significant benefits to the long-term health of a diabetic person [DCCT]. Previous studies show that on average, diabetic individuals test their glucose only 1.6 times a day (instead of the preferred 6-10 times). This is an indication that existing invasive finger stick glucose measuring devices do not serve their purpose. They are simple to use; however, diabetic individuals fail to use them routinely mainly because finger stick tests are painful, expensive, and messy. Although there is an urgent need, presently there is no available consumer device that can measure blood glucose noninvasively. VivaScan is in an advanced stage of developing a noninvasive handheld glucose monitor that uses measurements of the light transflected (backscattered) from the finger tip. Although the achieved results are nearing commercialization accuracy, we have encountered problems that are preventing us from further increasing the glucose measurement accuracy. This is due to the low detected light levels from the finger transflectance measurement system which reduces our signal to noise ratio. However, we have identified a means to resolve this issue. This Phase I grant proposal details how, by introducing a novel optical measurement method, we can increase the detected light levels in order to facilitate improvement of the measurement accuracy. Our ultimate goal is to bring our noninvasive blood glucose monitor to the market.

描述（由申请人提供）：VivaScan旨在通过向市场推出一种完全无创和无血的血糖仪来促进良好血糖控制的益处，该血糖仪将为糖尿病患者提供一种无痛的血糖检测方法。VivaScan开发了一种无创血糖监测仪，基于组织中近红外（NIR）光吸收的测量。我们的技术采用了专利的Optical BridgeT（OB）方法，这是著名的惠斯通电桥的光学等效物。OB测量样品在两个波长处的差分光学吸收的变化，以“消除”大的水和背景吸收，提供“更干净”的葡萄糖吸收信号，信号增强约为1500。SBIR赠款和公司资金使VivaScan能够开发并成功测试VS 191-一种先进的实验室原型手持式无创血糖监测仪。该设备采用光纤束非侵入性地测量血糖。在持续约20秒的测量过程中，将手指放入仪器中，轻轻挤压，在指尖照射光线，调节其血液含量，并测量和记录透射（反向散射）光。我们最近对10名志愿者进行的患者研究产生了450个数据对，平均绝对预测误差为12%，在Clarke误差网格的临床可接受的A和B区中的测量数据为100%（84%在120%误差范围内）。与光纤束相关的四个因素限制了经济实惠、紧凑且坚固的手持式无创血糖仪的发展。光纤束：1）具有低的光传输效率（~8%），导致低的测量信噪比; 2）昂贵（~ 1300美元）; 3）在设备内部需要大的空间（10 x 4 cm）;以及4）需要精确的可移动托架组件。该I期项目的目的是开发和测试一种无光纤束的新设备的可行性，该设备通过透射反射（后向散射）光学测量非侵入性地确定血糖。成功完成本提案的具体目标将导致提供更有效的操作、改进的精度、显著更便宜的制造成本和更紧凑的光生成/收集模块的设备。拟议SBIR第一阶段应用项目的目标包括：1）设计、构建和测试无光纤测量头; 2）构建VS 193无光纤手持式无创血糖监测仪; 3）进行内部患者试点研究，以测试和验证VS 193性能。第二阶段的工作将开发和测试一个功能齐全的紧凑，负担得起的，非侵入性血糖仪。所提出的设备对糖尿病患者的葡萄糖控制质量具有显著影响，但更重要的是，对他们的生活质量和寿命具有显著影响。使用VivaScan设备优化葡萄糖检测可以改善临床结果，并为个体患者和整个医疗保健系统节省大量成本。公共卫生相关性：糖尿病是一种痛苦的疾病，也是一个严重的公共卫生问题，今天在美国影响着2080多万人。美国国立卫生研究院糖尿病控制和并发症试验提供了令人信服的证据，表明频繁的血糖监测（每天超过4次）和严格的血糖控制对糖尿病患者的长期健康有显着的好处[DCCT]。以前的研究表明，平均而言，糖尿病患者每天只测试1.6次葡萄糖（而不是首选的6-10次）。这表明现有的侵入性手指针刺葡萄糖测量设备不能达到其目的。它们使用简单;然而，糖尿病患者不能常规使用它们，主要是因为手指针刺测试是痛苦的，昂贵的和混乱的。尽管存在迫切的需求，但目前还没有可以非侵入性地测量血糖的可用消费者设备。VivaScan正处于开发一种无创手持式血糖监测仪的高级阶段，该监测仪使用从指尖透射（反向散射）的光的测量。虽然所取得的结果接近商业化的精度，但我们遇到了一些问题，这些问题阻碍了我们进一步提高葡萄糖测量精度。这是由于从手指透反射测量系统检测到的低光水平，这降低了我们的信噪比。但是，我们已经找到了解决这个问题的方法。这份第一阶段拨款建议书详细说明了我们如何通过引入一种新的光学测量方法，提高检测到的光水平，以促进测量精度的提高。我们的最终目标是将我们的无创血糖监测仪推向市场。