Development of a Centralized Intelligence and Control AP Hub Device

 描述（由申请人提供）：尽管药物和医疗器械技术取得了重大进展，但安全有效地控制1型糖尿病患者血糖的能力仍然是一项艰巨的挑战，也是人类痛苦和经济成本的重要来源。随着连续葡萄糖监测（CGM）的出现，越来越多的努力集中在通过闭环控制（CLC）算法使用CGM与胰岛素泵耦合的人工胰腺（AP）系统的开发上。到目前为止，这些不同技术的集成和在商业产品中的实现面临着许多挑战。TypeZero Technologies的目标是将强大且经过广泛测试的糖尿病助手（DiAs）软件平台和支持技术商业化为商业级设备“中心”，旨在组织和控制医疗设备网络，以改善1型糖尿病背景下的血糖管理。迄今为止，DiAs原型已经过广泛测试，并已生成超过24,000小时的患者数据。在许多临床试验中，该技术显著降低了严重高血糖和低血糖事件的发生频率，降低了血糖变异性，并改善了患者的"范围内时间"（正常血糖率）。DiA和支持技术代表了一种完全不同的治疗模式的核心要素，该治疗模式将现有和当前批准的医疗器械的功能与专有软件平台和控制技术集成并最大化。TypeZero集线器的主要特征是：“模块化集线器功能可选地驻留在可用网络设备内和跨可用网络设备（包括患者的胰岛素泵、血糖仪、CGM、智能手机）或云服务内;”能够适应任何被认为最适合特定患者的控制策略;”固有的分层架构，设计有顺序模块部署的向上路径;"固有安全性，具有在组件故障的情况下优雅降级到已知系统状态的向下路径;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;其他服务和受试者和系统状态的远程监测可通过电信（例如，3G、WiFi等）实现。我们设想，在不久的将来，配备有适当软件（例如DiAs）的消费电子硬件将逐渐取代专门的CGM接收器或胰岛素泵控制器，将连续监测、胰岛素输送和闭环控制的功能合并到单个超便携平台中。在短期内，我们设想创建一个专用的集线器控制器，它将托管人工胰腺的关键功能，作为迈向未来的关键一步。

 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.