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Noninvasive Blood Glucose Monitoring Using Otoacoustic Emissions

使用耳声发射进行无创血糖监测

基本信息

批准号：
7555076
负责人：
Eric A Wan
金额：
$ 17.27万
依托单位：
OREGON HEALTH & SCIENCE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-01-10 至 2010-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7555076
关键词：
Acoustics Affect Algorithms Animals Arts Audiology Auditory Blood Blood Glucose Blood Vessels Brain Clinical Clinical Trials Cochlea Contralateral Data Development Devices Diabetes Mellitus Disease Ear Electrical Engineering Endocrinology Engineering Evaluation Exposure to Feedback Fingers Fright Future Glucose Glucose tolerance test Grant Hand Human Individual Investigation Ipsilateral Lead Link Literature Masks Measurement Measures Mechanics Methods Microalbuminuria Modeling Monitor Needles Neural Pathways Neuropathy Noise Non-linear Models Oryctolagus cuniculus Otolaryngology Outcomes Research Pain Patients Pattern Peripheral Persons Play Population Procedures Protocols documentation Reading Reporting Research Research Methodology Research Personnel Research Project Grants Retinal Diseases Risk Series Signal Transduction Site Stimulus Techniques Technology Testing Time Training base computer science computerized data processing cost diabetic diabetic patient glucose monitor instrumentation multidisciplinary non-diabetic novel otoacoustic emission patient population predictive modeling present value relating to nervous system research study response sound success transmission process

项目摘要

DESCRIPTION (provided by applicant): Project Summary The long term objective of the proposed research is to develop a new means for diabetic patients to painlessly and non-invasively monitor their blood glucose levels. There is convincing evidence that when diabetes patients actively monitor and control their blood glucose levels, long term complications including retinopathy and neuropathy can be avoided. Current monitoring technologies require the patient to prick their finger to extract blood, which can discourage a patient from actively monitoring their glucose levels. In this exploratory project, a novel method is proposed for noninvasive glucose monitoring. The method is based on the measurement and analysis of otoacoustic emissions (OAE). The OAE is a low-intensity sound generated by the cochlea in response to acoustic stimuli. Evoking and measuring an OAE is done using a tiny speaker and microphone that fits snugly inside of the ear. There is evidence from the literature that the temporal and spectral components of an OAE correlate with vascular glucose levels. This was confirmed in an animal study using rabbits. A single study investigating the link between OAEs and glucose in human diabetic subjects, however, did not show significant correlation. However, no studies have been performed which considered suppressed OAEs. The OAE response can be partially suppressed or masked by presenting a competing acoustic stimulus either contralaterally (opposite ear), ipsilaterally (same ear), or both. This suppression effect has been shown to be a result of neural efferent feedback from the brain. Neural effects including evoked responses and axonal transmission latencies are known to correlate with glucose. This suggests that suppressed OAEs may provide a robust correlation with glucose since the suppression is a result of peripheral neural feedback, and neural activity is affected by glucose levels. Preliminary experiments presented here provide strong evidence to support this hypothesis. This grant proposes additional more detailed experiments and evaluations. Specific aims include (1) determining optimal procedures for evoking and measuring suppressed OAEs that best correlate with blood glucose in diabetic and nondiabetic subjects, (2) developing parametric and non-parametric models to predict blood glucose levels, and (3) evaluating the prediction models based on clinical accuracy measures. Research methods include a number of experiments in which diabetic and non-diabetic subjects will be given a glucose tolerance test while suppressed and unsuppressed OAEs are measured. Signal processing algorithms will be applied to the OAE waveforms to evaluate how well temporal and spectral patterns correlate with blood glucose during the test. Control experiments will be done and potential interfering compounds will be independently assessed. The outcome from this research could ultimately lead to the future development of a low-cost, hand-held device that would be used by diabetic patients to painlessly and noninvasively monitor their glucose levels. Project Narrative/Relevance:Studies have shown that persons with diabetes can reduce the risk of complications associated with the disease significantly by actively monitoring their blood sugar levels. However, many diabetic patients fail to monitor their blood sugar for the primary reasons of finger soreness, pain, inconvenience, or fear of needles. In this project, a new method for enabling diabetic patients to painlessly and non-invasively monitor their glucose levels is proposed which uses low intensity sounds emitted from the ears.

描述(由申请人提供)：项目摘要拟议研究的长期目标是为糖尿病患者开发一种无痛和非侵入性监测他们的血糖水平的新方法。有令人信服的证据表明，当糖尿病患者积极监测和控制他们的血糖水平时，可以避免包括视网膜病变和神经病变在内的长期并发症。目前的监测技术要求患者刺破手指提取血液，这可能会阻碍患者主动监测他们的血糖水平。在这一探索性项目中，提出了一种新的无创血糖监测方法。该方法基于对耳声发射(OAE)的测量和分析。耳声发射是一种由耳蜗声刺激产生的低强度声音。唤醒和测量耳声发射是通过一个贴合在耳朵内的微型扬声器和麦克风来完成的。文献中有证据表明，耳声发射的时间和频谱成分与血管血糖水平相关。在一项用兔子进行的动物研究中证实了这一点。然而，一项对人类糖尿病受试者OAEs和血糖之间关系的单一研究并未显示出显著的相关性。然而，还没有进行过被认为是被抑制的OAE的研究。通过呈现对侧(对侧耳)、同侧(同侧耳)或两者兼而有之的相互竞争的声刺激，可以部分抑制或掩盖OAE反应。这种抑制效应被证明是来自大脑的神经传出反馈的结果。众所周知，包括诱发反应和轴突传递潜伏期在内的神经效应与葡萄糖相关。这表明，受抑制的OAEs可能与葡萄糖有很强的相关性，因为这种抑制是外周神经反馈的结果，而神经活动受葡萄糖水平的影响。这里提供的初步实验提供了强有力的证据来支持这一假说。这笔赠款建议进行更多更详细的实验和评估。具体目标包括：(1)确定最佳程序以诱发和测量与糖尿病和非糖尿病受试者的血糖最相关的受抑制的OAEs；(2)开发参数和非参数模型来预测血糖水平；以及(3)基于临床精确度评估预测模型。研究方法包括一些实验，其中糖尿病和非糖尿病受试者将接受葡萄糖耐量测试，同时测量受抑和未受抑的OAE。信号处理算法将被应用于OAE波形，以评估在测试期间时间和频谱模式与血糖的相关性如何。将进行对照实验，并将独立评估潜在的干扰化合物。这项研究的结果最终可能导致未来开发一种低成本的手持设备，供糖尿病患者使用，以无痛和非侵入性地监测他们的血糖水平。项目说明/相关性：研究表明，糖尿病患者可以通过积极监测他们的血糖水平，显著降低与疾病相关的并发症风险。然而，许多糖尿病患者未能监测他们的血糖，主要原因是手指酸痛、疼痛、不便或害怕打针。在这个项目中，提出了一种新的方法，使糖尿病患者能够无痛和非侵入性地监测他们的血糖水平，使用从耳朵发出的低强度声音。