MODULAR BIO-BEHAVIORAL CLOSED-LOOP CONTROL OF TYPE 1 DIABETES

1 型糖尿病的模块化生物行为闭环控制

• 批准号: 8325919
• 负责人: BORIS P KOVATCHEV
• 金额: $ 67.08万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-28 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8325919
• 关键词: Algorithms; Artificial Pancreas; Behavior; Behavior Therapy; Behavioral; Behavioral Model; Behavioral Sciences; Biological; Blood Glucose; Bolus Infusion; Caring; Characteristics; Computer Simulation; Controlled Study; Data; Detection; Development; Diabetes Mellitus; Dose; Elements; Engineering; Ensure; Evaluation; Event; Exercise; Exhibits; Feedback; Foundations; France; Glucose; Hormonal; Hospitals; Hour; Human; Hyperglycemia; Hypoglycemia; Individual; Injection of therapeutic agent; Inpatients; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; International; Italy; Learning; Maintenance; Measures; Metabolic; Metabolism; Nature; Outpatients; Patient observation; Patients; Pattern; Persons; Phase; Physicians; Physiological; Physiology; Prevention; Psychologist; Recurrence; Relative (related person); Research; Risk; Series; Staging; Stochastic Processes; Structure; System; Systems Development; Technology; Testing; Time; United States; abstracting; base; behavior observation; counterregulation; diabetes control; experience; field study; glucose monitor; high risk; indexing; individualized feedback; insulin sensitivity; models and simulation; prevent; response

MODULAR BIO-BEHAVIORAL CLOSED-LOOP CONTROL OF TYPE 1 DIABETES PROJECT SUMMARY / ABSTRACT By nature, the development of a closed-loop system (known as artificial pancreas) controlling blood glucose (BG) in diabetes is an interdisciplinary project involving physiology, behavioral science, and engineering. Consequently, this project represents an interdisciplinary and international effort of physicians, psychologists, mathematicians, and engineers from the United States, Italy, and France dedicated to the understanding of behavioral and biological prerequisites to individually-tailored closed-loop control of type 1 diabetes (T1DM). The principal idea of the proposed research is: in order to be successful, closed-loop control must adapt to individual physiologic characteristics and to the behavioral profile of each person. The keys to this adaptation are biosystem (patient) observation and modular control. Thus, we propose to lay the foundation for a modular system comprised of algorithmic observers of patients' behavior and metabolic state, and control modules responsible for insulin delivery and hypoglycemia prevention. Building this system, we will utilize our extensive expertise with in silico modeling and simulation of the human metabolism, and the experience from our recent closed-loop control studies. The development and testing of this system will be accomplished in four phases: Phase 1 will investigate patterns of behavioral events relevant to T1DM control. A field study will record meals, insulin injections, and exercise in parallel with continuous glucose monitoring, aiming to develop a learning algorithm - behavioral observer - which will track over time key recurrent elements of a person's routine. Phase 2 will investigate relationships of insulin sensitivity and impaired counterregulation with BG variability, aiming to develop algorithmic physiology observers, which will track specific parameters of glucose variability and recurrent hypoglycemia as markers of change in a person's insulin sensitivity and counterregulatory ability. Phase 3 will test in the field an advisory system providing personalized feedback to people with T1DM. The system will be informed by behavioral and physiology observers and will consist of three advisory modules: (i) evaluation of risk for hypoglycemia 24 hours ahead; (ii) bolus calculator suggesting pre-meal insulin doses, and (iii) basal rate advisor suggesting basal rate profiles for the next 24 hours. Phase 4 will focus on automated closed-loop control conducting a series of studies (outpatient & inpatient) testing sequentially three control modules responsible for: (i) detection and prevention of hypoglycemia 1-2 hours ahead, (ii) control of pre-meal insulin boluses, and (iii) control of basal rate and overnight steady state. We envision that, depending on patients' or physicians' choice, each observer or advisory/control module could be used separately, or within integrated open- or closed-loop control systems. A modular approach will permit incremental testing and deployment of system features, which will structure and facilitate system development.

1型糖尿病的模块化生物行为闭环控制 项目摘要 /摘要 本质上，控制血糖的闭环系统（称为人造胰腺）的开发 （BG）在糖尿病中是一个跨学科项目，涉及生理，行为科学和工程。 因此，该项目代表了医生，心理学家， 美国，意大利和法国的数学家以及工程师致力于理解 对1型糖尿病（T1DM）进行单独限制的闭环控制的行为和生物学先决条件。 拟议的研究的主要思想是：为了成功，闭环控制必须适应 个人生理特征和每个人的行为概况。这种改编的关键 是生物系统（患者）观察和模块化控制。因此，我们建议为模块化奠定基础 由患者行为和代谢状态的算法观察者组成的系统以及控制模块 负责胰岛素输送和预防低血糖。构建该系统，我们将利用我们的广泛 具有人类新陈代谢的计算机建模和模拟的专业知识，以及我们最近的经验 闭环控制研究。该系统的开发和测试将分为四个阶段： 第1阶段将研究与T1DM控制相关的行为事件模式。实地研究将记录一餐， 注射胰岛素，并与连续的葡萄糖监测并行运动，旨在发展学习 算法 - 行为观察者 - 它将跟踪一个人的例行程序的随着时间的流逝键的复发元素。 第2阶段将研究胰岛素敏感性和BG变异性的反调节受损的关系， 旨在开发算法生理观察者，该观察者将跟踪葡萄糖变异性的特定参数 以及复发性低血糖作为人胰岛素敏感性和反调节能力的变化标志。 第三阶段将在现场测试一个咨询系统，为T1DM的人提供个性化反馈。这 系统将由行为和生理观察者告知系统，并由三个咨询模块组成：（i） 评估低血糖的风险前24小时； （ii）推注计算器提示粉刷前胰岛素剂量，并且 （iii）基础利率顾问提出了接下来24小时的基础利率概况。 第4阶段将着重于进行一系列研究的自动闭环控制（门诊和住院） 依次测试三个控制模块：（i）检测和预防低血糖1-2 提前几个小时，（ii）控制粉刷前的胰岛素大力，以及（iii）基础速率和过夜稳态的控制。 我们设想，根据患者或医师的选择，每个观察者或咨询/控制模块都可以 单独使用，或在集成的开放环控制系统中使用。模块化方法将允许 系统功能的增量测试和部署，这将结构和促进系统开发。