Noninvasive Nocturnal Hypoglycemic Alarm

描述（由申请人提供）： ASL Analytical，Inc.爱荷华州大学的一个研究小组被提议开发一种非侵入性的夜间低血糖报警器。报警系统的目标是在糖尿病患者的睡眠期间提供连续的非侵入性测量，如果检测到即将发生的低血糖事件，则发出声音报警以唤醒患者。该系统将以组合近红外区域的连续光谱测量为基础。通过使用定制的傅里叶变换光谱仪和新型光纤接口，将通过睡眠者手背上的薄皮肤进行传输测量。患者将通过执行常规手指针刺葡萄糖测量并获取相应的参考光谱来启动监测会话。随后的光谱将参考该初始光谱，并且将使用新的模式分类算法来检测低血糖事件。在第一阶段申请中提出了体外和体内实验，以优化报警系统的硬件和软件组件。使用Sprague-Dawley大鼠进行的葡萄糖钳夹实验将用于确定光谱仪硬件、光纤接口和报警算法的性能特征。此外，光纤接口的优化将通过对人类受试者群体进行的实验来辅助。通过这些研究，将评估拟议的夜间报警的可行性，为潜在的第二阶段开发工作做准备。 低血糖是一种潜在的危及生命的疾病，其中血糖浓度降至正常值以下。严重低血糖的发作显著地导致I型糖尿病个体的发病率和死亡率，并且复发性低血糖可导致对脑功能的长期损害，包括记忆丧失和其他认知功能的退化。夜间低血糖对于许多I型糖尿病患者来说特别麻烦，因为它可能未被发现，并且它是低血糖无意识进展的一个组成部分。所提出的夜间报警代表了一种创新的方法，以显着降低低血糖发生的频率。我们的方法是非侵入性的，从而避免了困扰植入式生物传感器技术的生物相容性和感染相关的混淆问题。

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.