Development of a Universal Calibration Method for a Noninvasive Glucometer

描述（由申请人提供）：格罗夫仪器公司（前身为VivaScan）旨在通过向市场推出一种完全无创、无血和无痛的血糖仪来促进良好血糖控制的益处，该血糖仪允许所有糖尿病患者以最佳方式测试其血糖，从而改善其血糖控制。格罗夫Instrument的无创血糖仪基于血液中近红外（NIR）光吸收的测量。我们的技术采用了专利的“光桥”（OB）方法，这是一种与著名的惠斯通电桥等效的光学方法。SBIR赠款和公司资金使格罗夫仪器公司能够开发并成功测试一种先进的实验室原型手持式无创血糖仪。目前，我们的患者设备在使用前必须在三到四小时的测量过程中使用基于血液的血糖仪进行校准。我们的目标是测试开发一种通用校准方法的可行性，该方法将允许用户使用我们的无创血糖仪，而无需使用前校准，类似于脉搏血氧仪。目前，我们使用偏最小二乘回归为每个主题开发单独的模型。建议的新的通用模型使用基于主成分分析与模拟退火和大都会算法的分类方法。一项初步研究表明，通用模型与个体血液校准模型相比，平均误差降低了15%。拟议项目的具体目标包括：2）在MATLAB中开发用于通用校准模型的测试台，并使用所收集的数据测试潜在通用模型中的各种改进，3）将优化的MATLAB模型移植到C++中，以便能够实时操作，4）招募大的且人口统计学上平衡的糖尿病受试者队列用于临床测试，以便验证所提出的方法对研究中90%或更好的受试者起作用，无论年龄、性别或种族/民族背景，以及5）编写I期的最终报告。第二阶段的工作将开发和测试一个紧凑的，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血糖控制质量及其生活质量和寿命具有显著影响。使用格罗夫Instruments器械优化葡萄糖检测可改善临床结局，并为个体患者和整个医疗保健系统节省大量成本，并且通用校准器械的存在将为在尽可能广泛的人群中获得更好的血糖控制提供大量机会。

DESCRIPTION (provided by applicant): Grove Instruments (formerly VivaScan) 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. Grove Instrument's noninvasive blood glucometer is based on measurements of near-infrared (NIR) light absorption in blood. Our technology utilizes a patented Optical Bridge" (OB) method, an optical equivalent of the well-known electrical Wheatstone bridge. SBIR grant and company funds have enabled Grove Instruments to develop and successfully test an advanced laboratory prototype handheld noninvasive blood glucometer. Currently, our patient device must be calibrated with a blood-based glucometer prior to use during a three to four hour measurement session. Our objective is to test the feasibility of developing a universal calibration method which will allow the user to employ our noninvasive glucometer without a pre-use calibration session, similar to pulse oximetry. Currently, we use a partial least squares regression to develop individual models for each subject. The proposed new universal model uses a classification method based upon principal component analysis with a simulated annealing and a Metropolis algorithm. A pilot study showed a reduction in the average error by 15% for the universal model vs. the individual blood calibration model. Specific Aims for the proposed project include: 1) Collect measurement data from a cohort of demographically-diverse diabetic in order to provide a training set for the proposed Universal Calibration Model, 2) Develop a test bench for the universal calibration model in MATLAB and test various improvements in potential universal models using the data collected, 3) Port the optimized MATLAB model into C++ in order to enable real-time operation, 4) Recruit a large and demographically balanced cohort of diabetic subjects for clinical testing in order to verify the proposed method works on at 90% or better of the subjects in the study, regardless of age, gender, or racial/ethnic background, and 5) Write final report for Phase I. Phase II work will develop and test a compact, affordable noninvasive glucometer. The proposed device has dramatic implications for the quality of glucose control for diabetic persons and their quality of life and longevity. Optimizing glucose testing with the Grove Instruments device can lead to improved clinical outcomes and substantial cost savings to the individual patient and to the entire health care system, and the existence of a universally calibrated device would provide substantial opportunity to obtain better glycemic control on the widest possible segment of the population.