An accurate, fast, and miniaturized glucose sensor for closed-loop diabetes management

用于闭环糖尿病管理的准确、快速、小型葡萄糖传感器

• 批准号: 9898653
• 负责人: William Van Antwerp
• 金额: $ 78.69万
• 依托单位: INTEGRATED MEDICAL SENSORS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9898653
• 关键词: Adoption; Affect; Agreement; Animal Testing; Animals; Artificial Pancreas; Biocompatible Materials; Biotechnology; Blood; Businesses; Calibration; Carbohydrates; Cellular Phone; Chronic; Data; Data Analyses; Development; Devices; Diabetes Mellitus; Disease; Electric Capacitance; Electronics; Emergency department visit; Engineering; Environment; Excision; Family suidae; Feedback; Foreign Bodies; Foreign-Body Reaction; Funding; Geometry; Glucose; Goals; Grain; Health; Health Professional; Human; Hypoglycemia; Implant; In Vitro; Infection; Insulin; Insulin Infusion Systems; Insurance Coverage; Kinetics; Longevity; Measurement; Measures; Metabolism; Microelectrodes; Modeling; Morbidity - disease rate; Needles; Noise; Operative Surgical Procedures; Patients; Phase; Population; Pump; Rattus; Reaction Time; Reader; Reading; Reporting; Research; Research Personnel; Rice; Safety; Seasons; Semiconductors; Site; Skin; Sleep; Small Business Innovation Research Grant; Speed; Subcutaneous Tissue; Surveys; System; Technology; Testing; Thinness; Time; Tissues; Training; United States National Institutes of Health; Vascularization; Wireless Technology; Work; blood glucose regulation; cloud based; commercialization; cost; data visualization; design; diabetes management; diabetic; experience; first-in-human; flexibility; glucose monitor; glucose sensor; glycemic control; improved; innovation; irritation; microsystems; millimeter; miniaturize; monitoring device; mortality; novel; quality assurance; response; sensor; sensor technology; smart watch; subcutaneous; success; user-friendly

PROJECT SUMMARY The long term ​goal of this project is to develop a low-cost, user-friendly, and accurate glucose sensing solution with multisensor reliability to enable the use of closed-loop insulin delivery in an artificial pancreas. The system demonstrates fast sensor kinetics owing to small size, close proximity of sensor and related electronics, miniaturized electrodes with low capacitance, and thin and flexible profile leading to better integration with the surrounding tissue and local vascularization. This can enable automatic closed-loop glucose control without meal announcements and carbohydrate counting. The system also has excellent hypoglycemia accuracy due to small size and better integration with surrounding tissue (details available in research strategy). IMS has developed a novel, miniaturized (smaller than rice grain), completely wireless, and extremely low-cost glucose sensor that consists solely of a single semiconductor device (microsystem). This device can sense glucose owing to a novel microelectronics design and an integrated on-chip electrochemical sensor. This device is injected in subcutaneous tissue using a proprietary inserter and wirelessly communicates the glucose data to an external wearable transmitter which relays it to a smartphone to enable data visualization and cloud-based data handling to provide real-time feedback. With help of Caltech, NIH, and NSF funding, we have demonstrated sensor functionality in-vitro, in rats, and ​in porcine model for more than 1 month​. Our results indicate the sensor is very accurate (MARD=6.2% for <210 mg/dl which is the most important range), and can work for longer time (> 1 month) when compared to current transcutaneous CGM products. Moreover, the device is user-insertable and removable and hence eliminates the requirement of surgical procedures at doctor’s office as required by other wireless CGM devices (e.g. eversense by Senseonics). Our ​objective in this proposal is to develop a version of our glucose sensing platform that ​can be used for First-In-Human testing​. The proposed new microsystem will fit in a smaller (29 gauge) needle using a spring-loaded inserter to enable safe and accurate insertion. It will be attached to a small disk for safe removal of the sensor after its lifetime (e.g. after > 1 month). The device will measure glucose using ​three on-chip sensors to ​increase the reliability of the readout. The sensing platform will be tested in porcine model as it matches well with human skin and metabolism. This research is ​significant as it will enable the smallest in class (29 gauge insertable) factory-calibrated, user-insertable and removable, CGM that can work for a long time (>30 days), provide reliability of redundant glucose sensing, and fast response that can all enable safe and accurate closed-loop glucose control in an artificial pancreas. Also, the system offers lowest cost of goods by design owing to the semiconductor technology. The project ​team ​includes original inventors of the core technology from Caltech (Dr. Nazari, Dr. Rahman, Mr. Sencan), seasoned and respected researcher in Glucose sensor technology (Bill Van Antwerp), experimental surgery and biomaterials expert (Dr. Jonathan Lakey of UC Irvine) and commercialization expert (Mr. Peter Rule from MiniMed, Therasense, and OptiScan). The company is working within IVD Technologies Inc., an ISO certified, FDA registered biotechnology company under a facilities rental agreement.

项目摘要 该项目的长期目标是开发低成本，用户友好且准确的葡萄糖感应解决方案 具有多传感器的可靠性，可以在人工胰腺中使用闭环胰岛素。系统 由于尺寸较小，传感器和相关电子设备的近距离，演示了快速传感器动力学， 低电容的微型电子电子，薄而柔韧的轮廓，从而更好地整合 周围组织和局部血管形成。这可以实现无需自动闭环葡萄糖控制 进餐公告和碳水化合物计数。该系统还具有出色的低血糖精度 尺寸很小，与周围组织更好地整合（研究策略中可用的详细信息）。 IMS开发了一种新颖的，微型化的（比米粒小），完全无线和极低的成本 葡萄糖传感器仅由单个半导体设备（微系统）组成。这个设备可以感觉到 葡萄糖由于新型的微电子设计和整合的片上电化学传感器。这 使用专有插入器将设备注入皮下组织，并无线传达葡萄糖 将其传递到智能手机的外部可穿戴发射器到外部可穿戴发射机，以启用数据可视化和 基于云的数据处理以提供实时反馈。在Caltech，NIH和NSF资金的帮助下，我们有 在大鼠和猪模型中表现出传感器功能超过1个月。我们的结果 表明传感器非常准确（<210 mg/dl的mard = 6.2％，这是最重要的范围），并且可以 与当前的经皮CGM产品相比，工作时间更长（> 1个月）。而且， 设备是用户可用且可移动的，因此消除了手术程序的要求 医生办公室按照其他无线CGM设备的要求（例如，通过Senseonics进行Eversense）。 我们在此提案中的目标是开发一个可以用于的葡萄糖传感平台的版本 首次人类测试。拟议的新微型系统将使用较小的（29量规）的针头使用 弹簧插入器以实现安全而准确的插入。它将连接到一个小磁盘以进行安全去除 传感器寿命后的传感器（例如> 1个月后）。该设备将使用三个芯片测量葡萄糖 传感器以提高读数的可靠性。传感器将在猪模型中进行测试 与人类皮肤和新陈代谢相吻合。 这项研究很重要，因为它将使经过工厂校准的班级中最小的（29号插入） 用户可用且可移动的CGM可以长时间工作（> 30天），提供多余的可靠性 葡萄糖感应和快速反应，可以在一个安全和准确的闭环葡萄糖控制 人造胰腺。此外，由于半导体，该系统通过设计提供最低的商品成本 技术。 该项目团队包括加州理工学院的核心技术的原始发明者（Nazari博士，Rahman博士，先生 Sencan），葡萄糖传感器技术（Bill Van Antwerp）的经验丰富和受人尊敬的研究人员，实验性 外科和生物材料专家（UC Irvine的Jonathan Lakey博士）和商业化专家（Peter先生 最小化，therasense和optiscan的规则。该公司正在ISO ISO Inc. Inc. Inc. 根据设施租赁协议认证的FDA注册生物技术公司。