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.

项目摘要 在重症监护室（ICU）患者中未能实现严格的葡萄糖控制是发病和死亡的主要原因。 mortality.目前控制血糖的方法是针对近600万名入住ICU的患者， 一年中，护士必须检查患者的血糖，这是一个时间密集、容易出错的手动过程 水平，计算静脉注射（IV）胰岛素的剂量和速率，并调整IV泵。这些步骤可以减少 护理效率可提高至每名患者每天2小时。 理想医疗技术公司正在开发一种改进的ICU患者血糖控制系统。FUSION ™， 我们的闭环葡萄糖控制系统，作为一个人工胰腺;我们的创新中心使用仿生学 来设计我们的人工智能算法，使它们像葡萄糖调节系统一样工作， 存在于人类体内这些算法允许FUSION连续监测患者的血糖 水平并自主地将胰岛素和/或葡萄糖输注到患者体内以将血糖水平维持在 医生规定的范围。一种自动化的闭环方法来调节危重患者的血糖 将代表治疗方案的范式转变，并最终改变ICU的发病率和死亡率。 闭环血糖控制系统除了改善患者预后外的一个潜在额外益处是 减少血糖控制护理时间的可能性。 FDA在2019年将FUSION指定为突破性医疗器械，我们最初的IDE申请是 FDA今年批准的。在这个项目中，我们打算优化一个商业融合 首先在10人非随机临床安全性试验中进行测试，然后在30人随机 对照安全性和有效性试验-两项试验都将在埃默里大学的ICU进行。 该项目的成功完成将证明FUSION的临床安全性和初步有效性 闭环葡萄糖控制系统，并将使我们能够进入更大的疗效III期试验， 这些III期试验将完成我们的数据包 申请上市许可