Development of a Centralized Intelligence and Control AP Hub Device

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 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.