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

基于亲和传感器的双激素闭环血糖控制系统

• 批准号: 8390193
• 负责人: Ralph Ballerstadt
• 金额: $ 29.21万
• 依托单位: BIOTEX, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-15 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8390193
• 关键词: Affect; Affinity; Algorithms; Animal Model; Artificial Pancreas; Blood Glucose; Characteristics; Computer Simulation; Computers; Control Groups; Cytotoxin; Data; Detection; Development; Devices; Diabetes Mellitus; Ear; Engineering; Euglycemic Clamping; Family suidae; Feasibility Studies; Fluorescence; Generations; Glucagon; Glucose; Glucose Clamp; Hormones; Human; Hypoglycemia; Incidence; Individual; Infusion Pumps; Infusion procedures; Insulin; Insulin-Dependent Diabetes Mellitus; Intravenous; Literature; Measures; Methods; Minor; Modeling; Monitor; Noise; Outcome Measure; Phase; Pilot Projects; Population; Running; Safety; Scientist; Simulate; Streptozocin; System; Technology; Testing; Time; Validation; Veins; Wireless Technology; World Health Organization; base; blood glucose regulation; design; diabetes mellitus therapy; diabetic; follow-up; glucose monitor; glucose sensor; glycemic control; improved; innovation; intravenous administration; laptop; meetings; next generation; pre-clinical; preclinical study; predictive modeling; research study; sensor; simulation; usability; validation studies

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.

描述(由申请人提供)：世界卫生组织估计，全世界约有1.85亿人受到糖尿病的影响，大约。2000万人(约6%的人口)在美国受到影响(约这种1型糖尿病的10%)。在正常血糖范围内更严格的血糖控制被证明是将1型糖尿病所有长期并发症降至最低的唯一最重要的决定因素。实现更严格的血糖控制的一种方法是开发一种人工胰腺，它由一个连续的葡萄糖传感器和一个胰岛素输注泵组成。在这项应用中，BioTex的科学家和工程师将研究和开发一种基于亲和力传感器的双激素体外自动血糖控制的新范例，以改进糖尿病治疗。第一阶段的主要目标是证明糖尿病猪模型(麻醉)中血糖调节的可行性和有效性，使用来自FAS设备的实时数据，并通过描述良好和经过验证的模型预测控制(MPC)算法运行。如果成功，在第二阶段，这些结果的验证将在使用带有无线Fas监测器的糖尿病猪的动态实验中进行，随后将在人类中进行试点研究。 与公共健康相关：世界卫生组织估计，全世界约有1.85亿人受到糖尿病的影响，其中约有600万人患有糖尿病。2000万人(约6%的人口)在美国受到影响(约这些1型糖尿病患者中有10%)。在正常血糖范围内更严格的血糖控制被证明是将1型糖尿病所有长期并发症降至最低的唯一最重要的决定因素。实现更严格的血糖控制的一种方法是开发一种人工胰腺，它由一个连续的葡萄糖传感器和一个胰岛素输注泵组成。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基于亲和力传感器的双激素体外自动血糖控制的新范例，以改进糖尿病治疗。