A Smart Semiconductor based Integrated Continuous Diabetes Monitoring Platform

基于智能半导体的集成连续糖尿病监测平台

• 批准号: 10589708
• 负责人: Muhammad Mujeeb-U-Rahman
• 金额: $ 30万
• 依托单位: INTEGRATED MEDICAL SENSORS
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-10 至 2024-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10589708
• 关键词: Affect; American; Animal Model; Animals; Biocompatible Materials; Businesses; Calibration; California; Carbohydrates; Chairperson; Chemistry; Clinical; Communication; Computer software; Continuous Glucose Monitor; Cutaneous; Data; Data Analyses; Development; Devices; Diabetes Mellitus; Diabetic Ketoacidosis; Diet; Disease; Electric Capacitance; Electrodes; Encapsulated; Endocrinologist; Engineering; Enzymes; Event; Exercise; FDA approved; Family suidae; Feasibility Studies; Feedback; Foreign Bodies; Fright; Glucagon; Glucose; Goals; Health; Health Care Costs; Human; Hypoglycemia; Infection; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Intercellular Fluid; Ketones; Laboratories; Longevity; Measures; Medical; Membrane; Metabolic; Metabolic Diseases; Metabolic syndrome; Metabolism; Methods; Miniaturization; Monitor; Needles; Noise; Operative Surgical Procedures; Pain Free; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Process; Reaction Time; Reader; Research; Research Personnel; Risk; Safety; Scheme; Seasons; Semiconductors; Sesame - dietary; Signal Transduction; Site; Skin; Small Business Innovation Research Grant; Speed; System; Techniques; Technology; Temperature; Testing; Thick; Thinness; Time; Tissues; Training; United States National Institutes of Health; Update; Work; blood glucose regulation; commercialization; cost; design; diabetes management; diabetes risk; diabetic; experience; flexibility; glucose sensor; improved; in vivo; inhibitor; innovation; integrated circuit; interest; microsensor; novel; patient advocacy group; porcine model; research and development; response; risk minimization; sensor; sensor technology; smart watch; subcutaneous; user-friendly; wireless

PROJECT SUMMARY The long-term goal of this project is to develop a scalable, user-friendly, continuous diabetes monitoring (CDM) system to minimize the risk of diabetic ketoacidosis (DKA) for millions of diabetes patients, especially those with type I diabetes by adding continuous ketone monitoring (CKM) to the IMS continuous glucose monitor (CGM). IMS has developed the world's smallest wireless electrochemical CGM using a novel semiconductor (CMOS) platform. This design offers some unique advantages due to its smart sensor (compared to passive sensors in competitor designs) including extreme miniaturization (system is smaller than half a sesame seed), on-chip integration of multiple sensors, improvement in signal-to-noise ratio (thus improving hypoglycemia accuracy), decrease in sensor capacitance and membrane thickness (thus improving response speed), and on-chip temperature calibration. This system can enable automatic closed-loop glucose control without meal announcements and carbohydrate counting and without the fear of missed hypoglycemic events; greatly simplifying patient experience and improving safety. We have demonstrated the function of our CGM platform in the lab, in animals, and recently in humans. The addition of CKM can significantly improve the value of the system to detect impending DKA that goes unnoticed with the current CGM systems, causing significant harm to the at-risk patients. Therefore, our objective in this proposal is to develop a multi-analyte sensing platform that can sense both glucose and ketone in the interstitial fluid (ISF) using a single device. The sensing platform will be tested both in the lab and in a porcine model (matches well with human skin and metabolism). This research is significant as it will enable the first CDM system with a small, pain-free needle- insertion (26-gauge needle) that can work for a long time (>30 days). Once proven, this system can be extended to include other important analytes (e.g., insulin, glucagon) without increasing its size or complexity, owing to on-chip integration of multiple sensors on a single microscale device. The team includes original inventors of the core technology from California Institute of Technology (Dr. Nazari, Dr. Rahman, Mr. Sencan), seasoned and respected researcher in Glucose sensor technology (Bill Van Antwerp, former CSO of Medtronic MiniMed), surgery and biomaterials expert (Dr. Jonathan Lakey of UC Irvine), regulatory and IP expert (John Heithaus, JD), commercialization expert (Mr. Peter Rule; former President of MiniMed, Chairman of Therasense, and OptiScan), and clinical expert (Dr. Alan Marcus, MD; former Chief Medical Officer of Medtronic Diabetes). The project is supported by patient advocacy groups like JDRF and practicing endocrinologists like Dr. Anne Peters.

项目概要 该项目的长期目标是开发一种可扩展的、用户友好的、连续的糖尿病监测系统 （CDM）系统可最大限度地降低数百万糖尿病患者患糖尿病酮症酸中毒（DKA）的风险， 特别是那些患有 I 型糖尿病的患者，通过在 IMS 中添加连续酮监测 (CKM) 连续血糖监测仪（CGM）。 IMS开发出世界上最小的无线电化学 CGM 使用新型半导体 (CMOS) 平台。这种设计提供了一些独特的优势，因为 其智能传感器（与竞争对手设计中的无源传感器相比）包括极端 小型化（系统比半个芝麻还小）、片上集成多个传感器、 信噪比改善（从而提高低血糖准确度），传感器减少 电容和薄膜厚度（从而提高响应速度）以及片上温度 校准。该系统可以实现自动闭环血糖控制，无需通知用餐 和碳水化合物计数，无需担心错过低血糖事件；大大简化 患者体验并提高安全性。 我们已经在实验室、动物身上以及最近在人类身上展示了 CGM 平台的功能。 CKM的加入可以显着提高系统检测即将发生的DKA的价值 当前的 CGM 系统没有注意到这一点，对高危患者造成重大伤害。 因此，我们在本提案中的目标是开发一个可以感知的多分析物传感平台 使用单个设备同时检测间质液 (ISF) 中的葡萄糖和酮。传感平台将是 在实验室和猪模型中进行了测试（与人类皮肤和新陈代谢非常匹配）。 这项研究意义重大，因为它将实现第一个带有小型无痛针的 CDM 系统 插入（26 号针）可长期工作（>30 天）。一旦经过验证，该系统可以 扩展到包括其他重要的分析物（例如胰岛素、胰高血糖素），而无需增加其尺寸或 由于在单个微型器件上集成了多个传感器，因此变得复杂。 该团队包括来自加州理工学院的核心技术原始发明人（Dr. Nazari、Rahman 博士、Sencan 先生），葡萄糖传感器技术领域经验丰富且受人尊敬的研究员 （Bill Van Antwerp，Medtronic MiniMed 前 CSO），外科和生物材料专家（Jonathan 博士） 加州大学欧文分校的 Lakey）、监管和知识产权专家（John Heithaus，法学博士）、商业化专家（Peter 先生） 规则; MiniMed 前总裁、Therasense 和 OptiScan 董事长）、临床专家（Dr. 艾伦·马库斯，医学博士；前美敦力糖尿病首席医疗官）。该项目由以下机构支持 JDRF 等患者权益团体和 Anne Peters 博士等执业内分泌学家。