Demonstration of the Feasibility of Closed Loop Control of Blood Glucose in the Intensive Care Unit Setting Using a Novel Artificial Intelligence Based Glucose Control System

使用基于人工智能的新型血糖控制系统演示重症监护病房中血糖闭环控制的可行性

• 批准号: 10631190
• 负责人: Leon DeJournett
• 金额: $ 93.11万
• 依托单位: IDEAL MEDICAL TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10631190
• 关键词: Address; Admission activity; Adult; Algorithms; Artificial Intelligence; Artificial Pancreas; Blood Glucose; COVID-19 pandemic; Clinical; Clinical Trials; Collaborations; Computer software; Continuous Glucose Monitor; Critical Illness; Data; Development; Devices; Discipline of Nursing; Dose; Engineering; Environment; Failure; Food Packaging; Glucose; Grant; Head; Hour; Human; Hyperglycemia; Hypoglycemia; Infusion procedures; Insulin; Intensive Care Units; Intravenous; Legal patent; Link; Liver; Manuals; Marketing; Measures; Medical Device; Medical Technology; Methods; Monitor; Morbidity - disease rate; Names; Nurses; Pancreas; Patient Admission; Patient Care; Patient-Focused Outcomes; Patients; Pattern; Persons; Phase; Phase III Clinical Trials; Physicians; Process; Programming Languages; Pump; Randomized; Randomized, Controlled Trials; Reading; Resistance; Risk; Safety; Speed; Stress; System; Technology; Testing; Time; Translating; Treatment Protocols; United States; United States Food and Drug Administration; Universities; Variant; artificial intelligence algorithm; blood glucose regulation; commercialization; cyber security; design; diabetic; effectiveness evaluation; efficacy study; efficacy trial; experience; first-in-human; glucose monitor; human error; improved; in silico; in vivo; innovation; instrument; mortality; non-diabetic; novel; phase III trial; porcine model; prospective; safety study; usability

PROJECT SUMMARY Failure to achieve tight glucose control in intensive care unit (ICU) patients is a major cause of morbidity and mortality. The current method for controlling glucose for the almost 6 million patients admitted to the ICU each year consists of time-intensive, error-prone, manual processes in which nurses have to check patient glucose levels, calculate dosing and rates for intravenous (IV) insulin, and adjust IV pumps. These steps can decrease nursing efficiency by up to 2 hours per patient per day. Ideal Medical Technologies is developing an improved system for glucose control in ICU patients. FUSIONTM, our closed-loop glucose control system, acts as an artificial pancreas; our innovation centers on using biomimicry to design our artificial intelligence-based algorithms so that they function like the glucose regulation system natively present in humans. These algorithms allow FUSION to continuously monitor a patient’s blood glucose level and autonomously infuse insulin and/or dextrose into the patient to maintain the blood glucose level within a physician-prescribed range. An automated, closed-loop approach to regulating glucose in critically ill patients would represent a paradigm shift in treatment protocols, and ultimately, morbidity and mortality rates in the ICU. One potential additional benefit of a closed-loop glucose control system beyond improved patient outcomes is the possibility of decreasing nursing time spent on glucose control. The FDA designated FUSION as a Breakthrough Medical Device in 2019, and our original IDE application was approved by the FDA as of this year. In this proposed project, we intend to optimize a commercial FUSION system and test it first in a 10-person non-randomized clinical safety trial and then in a 30-person randomized controlled safety and efficacy trial – both trials will be performed in an ICU at Emory University. Successful completion of this project will demonstrate clinical safety and preliminary efficacy of the FUSION closed-loop glucose control system and will enable us to then move into larger efficacy Phase III trials in a subsequent stage of development and commercialization; these Phase III trials will complete our data package for the FDA for marketing approval.

项目概要 重症监护病房 (ICU) 患者未能实现严格的血糖控制是发病率和死亡率的主要原因 死亡。目前入住 ICU 的近 600 万名患者的血糖控制方法 一年中包括耗时、容易出错的手动流程，护士必须在其中检查患者的血糖 水平，计算静脉 (IV) 胰岛素的剂量和速率，并调整 IV 泵。这些步骤可以减少 每名患者每天的护理效率最多可提高 2 小时。 Ideal Medical Technologies 正在开发一种改进的系统，用于 ICU 患者的血糖控制。融合™， 我们的闭环葡萄糖控制系统，充当人工胰腺；我们的创新中心是使用仿生学 设计我们基于人工智能的算法，使其像葡萄糖调节系统一样发挥作用 天然存在于人类中。这些算法使 FUSION 能够持续监测患者的血糖 水平并自主向患者输注胰岛素和/或葡萄糖，以将血糖水平维持在 医生规定的范围。一种调节危重患者血糖的自动化闭环方法 将代表治疗方案的范式转变，并最终代表 ICU 发病率和死亡率的转变。 除了改善患者治疗结果之外，闭环血糖控制系统的另一个潜在好处是 减少用于血糖控制的护理时间的可能性。 FDA 于 2019 年将 FUSION 指定为突破性医疗器械，我们最初的 IDE 应用程序是 今年已获得 FDA 批准。在这个拟议的项目中，我们打算优化商业 FUSION 系统并首先在 10 人非随机临床安全试验中进行测试，然后在 30 人随机临床安全试验中进行测试 受控安全性和有效性试验——两项试验都将在埃默里大学的 ICU 中进行。 该项目的成功完成将证明FUSION的临床安全性和初步疗效 闭环葡萄糖控制系统，将使我们能够进入更大规模的疗效 III 期试验 后续开发和商业化阶段；这些 III 期试验将完善我们的数据包 FDA 上市批准。