Affinity Sensor-based Dual-Hormone Closed-Loop Glucose Control System

描述（由申请人提供）：世界卫生组织估计，糖尿病影响全世界约1.85亿人，其中约有100万人患有糖尿病。2000万人（约6%的人口）在美国（约。10%的1型糖尿病患者）。在正常血糖范围内更严格的血糖控制被证明是最大限度地减少1型糖尿病所有长期并发症的唯一最重要的决定因素。实现更严格血糖控制的一种方法涉及人工胰腺的开发，该人工胰腺由连续葡萄糖传感器和胰岛素输注泵组成。 在这项应用中，BioTex的科学家和工程师将研究和开发一种新的基于亲和传感器的双激素体外自动血糖控制模式，以改善糖尿病治疗。I期研究的主要目的是使用来自FAS装置的实时数据，并通过充分描述和验证的模型预测控制（MPC）算法运行，证明糖尿病猪模型（麻醉）中血糖调节的可行性和有效性。如果成功，在第二阶段，这些结果的验证将在移动实验中使用糖尿病猪与无线FAS监测器进行，然后在人类中进行试点研究。 公共卫生相关性：世界卫生组织估计，糖尿病影响着全球约1.85亿人，其中约有100万人患有糖尿病。2000万人（约6%的人口）在美国（约。10%的1型糖尿病患者）。在正常血糖范围内更严格的血糖控制被证明是最大限度地减少1型糖尿病所有长期并发症的唯一最重要的决定因素。实现更严格血糖控制的一种方法涉及人工胰腺的开发，该人工胰腺由连续葡萄糖传感器和胰岛素输注泵组成。 在这项应用中，BioTex公司的科学家和工程师将开发和研究一种新的基于亲和传感器的双激素体外自动血糖控制模式，以改善糖尿病治疗。

DESCRIPTION (provided by applicant): The World Health Organization estimates that diabetes affects about 185 million people worldwide, with approx. 20 million individuals (approx. 6 percent by population) afflicted in the US (approx. 10 percent of this type 1 diabetes). Tighter glucose control within the euglycemic range was shown to be the single most important determinant for minimizing all long-term complications of type 1 diabetes. One method to achieve tighter blood glucose control involves the development of an artificial pancreas, consisting of a continuous glucose sensor, and an insulin infusion pump. In this application, BioTex scientists and engineers will investigate and develop a new paradigm of an affinity-sensor based dual-hormone extracorporeal automated glycemic control for improving diabetes therapy. The major objective in the Phase I is to demonstrate feasibility and efficacy of the blood-glucose regulation in a diabetic swine model (anesthetized), using real-time data from the FAS device, and run by a well- described, and validated model-predictive control (MPC) algorithm. If successful, in Phase II the validation of these results will then be performed in ambulatory experiment using diabetic pigs with a wireless FAS monitor, followed by pilot studies in humans. PUBLIC HEALTH RELEVANCE: The World Health Organization estimates that diabetes affects about 185 million people worldwide, with approx. 20 million individuals (approx. 6 percent by population) afflicted in the US (approx. 10 percent of these type 1 diabetes). Tighter glucose control within the euglycemic range was shown to be the single most important determinant for minimizing all long-term complications of type 1 diabetes. One method to achieve tighter blood glucose control involves the development of an artificial pancreas, consisting of a continuous glucose sensor, and an insulin infusion pump. In this application scientists and engineers of BioTex, Inc will develop and investigate a new paradigm of an affinity-sensor based dual-hormone extracorporeal automated glycemic control for improving diabetes therapy.