Development of a Centralized Intelligence and Control AP Hub Device

集中智能控制AP Hub装置的研制

• 批准号: 8823176
• 负责人: Jeffrey Keller
• 金额: $ 22.44万
• 依托单位: TYPEZERO TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-24 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8823176
• 关键词: Adverse event; Algorithms; Architecture; Area; Artificial Pancreas; Blood Glucose; Carbohydrates; Cardiovascular system; Caring; Characteristics; Clinical; Clinical Trials; Communication; Complex; Computer software; Continuous Infusion; Contracts; Coupled; Data; Databases; Development; Devices; Diabetes Mellitus; Diagnostic; Drug Kinetics; Electronics; Elements; Environment; Event; Exercise; Exogenous Factors; Failure; Focus Groups; Frequencies; Future; Goals; Health Care Costs; Health Insurance Portability and Accountability Act; Hour; Human; Hyperglycemia; Hypoglycemia; Incidence; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Intelligence; Judgment; Kidney Failure; Licensing; Life; Machine Learning; Manufacturer Name; Medical Device; Metabolism; Modeling; Monitor; Neuropathy; Outcome; Pathway interactions; Patient Monitoring; Patients; Pharmacologic Substance; Phase; Phase II Clinical Trials; Preparation; Procedures; Process; Protocols documentation; Provider; Pump; Quality of life; Replacement Therapy; Research; Retinal Diseases; Running; Safety; Secure; Services; Small Business Innovation Research Grant; Solutions; Source; Supervision; System; Technology; Telecommunications; Telemedicine; Testing; Time; Transition Elements; Uncertainty; Universities; Virginia; Wireless Technology; base; cloud based; commercialization; design; economic cost; experience; glucose monitor; glucose sensor; glycemic control; graphical user interface; improved; meter; middleware; monitoring device; novel; operation; patient safety; prototype; public health relevance; safety testing; subcutaneous

 DESCRIPTION (provided by applicant): Despite major advances in pharmaceuticals and medical device technology, the ability to safely and effectively control blood glucose in patients with Type 1 diabetes has remained a recalcitrant challenge and a significant source of human suffering and economic cost. With the advent of continuous glucose monitoring (CGM), increasing effort has been focused on the development of artificial pancreas (AP) systems using CGM coupled with insulin pump via closed-loop control (CLC) algorithms. Integration of these disparate technologies and implementation in a commercial product has faced numerous challenges to date. TypeZero Technologies' objective is the commercialization of the robust and extensively tested Diabetes Assistant (DiAs) software platform and supporting technology into a commercial-grade device "hub" designed to organize and control a network of medical devices for the improved management of blood glucose in the context of Type 1 diabetes. The DiAs prototype has been extensively tested to date, and has generated over 24,000 hours of on- patient data. In numerous clinical trials, this technology has reduced dramatically the frequency of occurrence of severe hyper- and hypoglycemic events, reduced glycemic variability and improved patient's "time-in-range" (rate of euglycemia). DiAs and supporting technologies represent the core elements of a radically different treatment paradigm that integrates and maximizes the capabilities of existing and currently approved medical devices with a proprietary software platform and control technologies. The key characteristics of the TypeZero hub are: " Modular hub functionality residing optionally within and across available networked devices including the patient's pump, meter, CGM, smartphone, or within cloud services; " Ability to accommodate any control strategy that is deemed optimal for a specific patient; " Inherently layered architecture, designed with an upward pathway of sequential module deployment; " Inherent safety, featuring a downward pathway of graceful degradation to a known system state in the event of component failure; and " Local and Global modes of operation enabling the availability of certain processes and patient interaction through the portable device; other services and remote monitoring of subject and system state are available via telecommunication (e.g. 3G, WiFi, etc.). We envision that in the near future consumer electronics hardware equipped with appropriate software (e.g. DiAs) would gradually replace specialized CGM receivers or insulin pump controllers, merging into a single ultra-portable platform the functions of continuous monitoring, insulin delivery, and closed-loop control. In the near-term, we envision creating a dedicated hub controller that will host key functionalities of artificial pancreas as a critical step toward the future.

 描述（由申请人提供）：尽管药品和医疗器械技术取得了重大进步，但安全有效地控制 1 型糖尿病患者血糖的能力仍然是一个顽强的挑战，也是人类痛苦和经济成本的重要来源。随着连续血糖监测 (CGM) 的出现，越来越多的努力集中在通过闭环控制 (CLC) 算法将 CGM 与胰岛素泵相结合的人工胰腺 (AP) 系统的开发上。迄今为止，商业产品面临着无数挑战，TypeZero Technologies 的目标是将强大且经过测试的糖尿病助手 (DiAs) 软件平台和支持技术商业化为商业级设备“中心”，旨在广泛组织和控制糖尿病患者网络。用于改善 1 型糖尿病血糖管理的医疗设备 DiAs 原型迄今为止已经过测试，并在大量临床试验中生成了超过 24,000 小时的患者数据。发生频率严重的高血糖和低血糖事件、降低血糖变异性和改善患者的“时间范围”（血糖正常率）和支持技术代表了一种完全不同的治疗模式的核心要素，该模式整合并最大化了现有和当前的能力。 TypeZero 集线器的主要特点是：“模块化集线器功能可选地驻留在可用的网络设备内和之间，包括患者的泵、仪表、CGM、智能手机或云服务； “ 能够适应任何被认为对特定患者最佳的控制策略； “ 固有的分层架构，设计有顺序模块部署的向上路径； “ 固有的安全性，具有优雅降级的向下路径；发生组件故障时的已知系统状态；以及“本地和全局操作模式，通过便携式设备实现某些过程和患者交互的可用性；通过电信（例如 3G）提供其他服务以及对受试者和系统状态的远程监控， 无线上网，我们预计，在不久的将来，配备有适当软件的消费电子产品（例如 DiAs）将逐渐取代专门的 CGM 接收器或胰岛素泵控制器，将连续监测、胰岛素输送、在短期内，我们设想创建一个专用的集线器控制器，它将承载人工胰腺的关键功能，作为迈向未来的关键一步。