Noninvasive Nocturnal Hypoglycemic Alarm

无创夜间低血糖警报

• 批准号: 7433856
• 负责人: MARK A. ARNOLD
• 金额: $ 47.54万
• 依托单位: ASL ANALYTICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-06-01 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7433856
• 关键词: Affect; Algorithms; Animal Model; Applications Grants; Back; Biosensor; Blood Glucose; Brain; Characteristics; Classification; Clinic; Clinical Trials; Computer software; Condition; Daily; Dermis; Development; Device or Instrument Development; Devices; Diabetes Mellitus; Drops; Elements; Event; Feasibility Studies; Fiber Optics; Fingers; Fourier Transform; Frequencies; Glucose; Glucose Clamp; Goals; Hand; Health; Home environment; Hour; Human; Hydration status; Hypoglycemia; Hypoglycemic Agents; In Vitro; Individual; Infection; Insulin-Dependent Diabetes Mellitus; Iowa; Joints; Life; Measurement; Measures; Memory Loss; Monitor; Morbidity - disease rate; Movement; Names; Near-Infrared Spectroscopy; Normal Range; Operative Surgical Procedures; Optics; Patients; Pattern; Performance; Persons; Phase; Phase II Clinical Trials; Plague; Population; Preparation; Private Sector; Property; Purpose; Rate; Recurrence; Research; Skin; Skin Tissue; Sleep; Small Business Technology Transfer Research; Sprague-Dawley Rats; System; Technology; Temperature; Time; Tissues; Universities; base; biomaterial compatibility; cognitive function; design; glucose monitor; glycemic control; human subject; improved; in vivo; innovation; instrument; instrumentation; mortality; novel; programs; research study; sound; tool; transmission process

DESCRIPTION (provided by applicant): A collaborative effort between ASL Analytical, Inc. and a research team at the University of Iowa is proposed to development a noninvasive nocturnal hypoglycemic alarm. The goal for the alarm system is to provide continuous noninvasive measurements during the sleep period of an individual with diabetes, sounding an audible alarm to wake the person if an impending hypoglycemic event is detected. The system will be based on continuous spectral measurements in the combination near infrared region. Through the use of a customized Fourier transform spectrometer and novel fiber-optic interface, transmission measurements will be made through the thin skin on the back of the hand of the sleeping person. The patient will initiate the monitoring session by performing a conventional finger-stick glucose measurement and acquiring a corresponding reference spectrum. Subsequent spectra will be referenced to this initial spectrum, and a novel pattern classification algorithm will be used to detect hypoglycemic events. Both in vitro and in vivo experiments are proposed in this Phase I application to optimize the hardware and software components of the alarm system. Glucose clamp experiments performed with Sprague-Dawley rats will be used to establish the performance characteristics of the spectrometer hardware, fiber-optic interface, and alarm algorithm. In addition, optimization of the fiber-optic interface will be aided by experiments performed with a population of human subjects. Through these studies, the feasibility of the proposed nocturnal alarm will be evaluated in preparation for a potential Phase II development effort. Hypoglycemia is a potentially life-threatening condition where blood glucose concentrations drop below normal values. Episodes of severe hypoglycemia contribute significantly to the morbidity and mortality of individuals with type I diabetes and recurrent hypoglycemia can result in long-lasting damage to brain function including memory loss and degradation of other cognitive functions. Nocturnal hypoglycemia is particularly troublesome for many individuals with type I diabetes because it can go undetected and it is one component in the progression of hypoglycemic unawareness. The proposed nocturnal alarm represents an innovative approach to reduce significantly the frequency of hypoglycemic occurrences. Our approach is noninvasive, thereby avoiding confounding issues associated with biocompatibility and infection that plague implantable biosensor technologies.

描述（由申请人提供）： ASL Analytication，Inc。与爱荷华大学的研究团队之间的合作努力是为了开发非侵入性的夜间降糖警报。警报系统的目的是在患有糖尿病的人的睡眠期间提供连续的无创测量值，如果检测到即将发生的降血糖事件，声音听起来可唤醒该人。该系统将基于红外区域附近组合的连续光谱测量。通过使用定制的傅立叶变换光谱仪和新型的光纤接口，将通过浅色皮肤在熟睡中的手背上的薄皮进行传输测量。患者将通过执行常规的指葡萄糖测量并获得相应的参考光谱来开始监测。随后的光谱将参考此初始光谱，并将使用一种新型的模式分类算法来检测降血糖事件。在此阶段I应用程序中提出了体外和体内实验，以优化警报系统的硬件和软件组件。 Sprague-Dawley大鼠进行的葡萄糖夹夹实验将用于建立光谱仪硬件，光纤接口和警报算法的性能特征。此外，通过对人类受试者的人群进行的实验，将有助于光纤界面的优化。通过这些研究，将评估提出的夜间警报的可行性，以准备潜在的II期发展工作。 低血糖是一种潜在的威胁生命的疾病，其中血糖浓度降至正常值以下。严重低血糖的发作显着促进了I型糖尿病和复发性低血糖的个体的发病率和死亡率，可能会对脑功能造成长期的损害，包括记忆丧失和其他认知功能的降解。对于许多I型糖尿病患者而言，夜间低血糖特别麻烦，因为它可能未被发现，并且是降血糖不认识发展的一个组成部分。提出的夜间警报代表了一种创新的方法，可显着降低降血糖事件的频率。我们的方法是无创的，从而避免了困扰可植入生物传感器技术的生物相容性和感染相关的混淆问题。