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: 8732733
• 负责人: Ralph Ballerstadt
• 金额: $ 7.5万
• 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/8732733
• 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.

描述（由申请人提供）：世界卫生组织估计，全世界约有 1.85 亿人患有糖尿病，其中约 1.8 亿人患有糖尿病。美国有 2000 万人（约占总人口的 6%）患有该病（约占 1 型糖尿病的 10%）。事实证明，将血糖严格控制在正常血糖范围内是最大限度减少 1 型糖尿病所有长期并发症的最重要的决定因素。实现更严格血糖控制的一种方法涉及开发人造胰腺，该胰腺由连续葡萄糖传感器和胰岛素输注泵组成。 在此应用中，BioTex 科学家和工程师将研究和开发一种基于亲和传感器的双激素体外自动血糖控制的新范例，以改善糖尿病治疗。第一阶段的主要目标是使用来自 FAS 设备的实时数据，并通过经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，将使用配备无线 FAS 监测仪的糖尿病猪进行流动实验，对这些结果进行验证，然后在人体中进行试点研究。