Continuous Glucose Monitoring with a Subcutaneous, Non-enzymatic Fluorescent Sens

使用皮下非酶荧光传感器进行连续血糖监测

• 批准号: 8196176
• 负责人: Jeff Thomas Suri
• 金额: $ 42.78万
• 依托单位: GLUMETRICS, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-15 至 2012-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8196176
• 关键词: Adhesions; Adolescent; Adoption; American; Animal Model; Animals; Artificial Pancreas; Back; Boronic Acids; Calibration; Capital; Chemicals; Chemistry; Clinical; Clinical Research; Clinical Trials; Critical Illness; Development; Devices; Diabetes Mellitus; Failure; Family suidae; Fluorescence; Foundations; Generations; Glucose; HDPE; Human; Hydration status; Hypoglycemia; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Insurance; Manufacturer Name; Marketing; Measures; Membrane; Metric; Microdialysis; Modeling; Optics; Patients; Performance; Peripheral; Phase; Physiological; Polyethylene Glycols; Preclinical Testing; Proteins; Pump; Reaction Time; Reading; Relative (related person); Research; Research Project Grants; Resistance; Running; Safety; Subcutaneous Tissue; Surface; System; Technology; Testing; Therapeutic; Time; United States; Veins; Work; arm; base; commercialization; design; glucose monitor; glucose oxidase; glucose sensor; healthy volunteer; hydrophilicity; improved; in vitro testing; in vivo; meetings; miniaturize; monitoring device; next generation; novel; optical fiber; polyether sulfone; preclinical study; prototype; sensor; subcutaneous; success

DESCRIPTION (provided by applicant): The Juvenile Diabetes Research Foundation (JDRF) estimates that up to 3 million people in the United States may have Type 1 diabetes. Recent large clinical trials have demonstrated the therapeutic benefits of continuous glucose monitors (CGMs), leading the way to increased availability of insurance reimbursement of these devices. An estimated 50,000 people with diabetes currently use CGMs, but adoption is forecast to grow steadily to 250,000 users as insulin pump users exchange their devices for next generation pumps with integrated CGMs. This represents a $500 million market opportunity. However, currently available CGMs have technical shortcomings that limit both near-term widespread clinical adoption and longer-term progress towards an artificial pancreas. These limitations include inaccuracy in the hypoglycemic range, frequent calibration requirements, and long run-in times. More importantly, the eventual successful commercialization of an artificial pancreas will likely require the use of multiple redundant sensors for safety. There could be substantial advantages associated with the use of a non-enzymatic, redundant sensor in this context, namely, avoidance of common mode failures. GluMetrics is a venture capital-backed company developing the GluCath Intravascular Continuous Glucose Monitoring System (GluCath System). The sensor in this device uses a novel quenched fluorescence chemical mechanism deployed via an optical fiber. The GluCath System is designed for use in critically-ill patients undergoing intensive insulin therapy. Clinical feasibility has been demonstrated in fifty-two healthy volunteer subjects with Type 1 diabetes mellitus for up to 24 h duration. In these studies, the GluCath sensor was placed in a peripheral vein in the arm. The results agreed closely with a reference glucose analyzer with a 7.5% mean absolute relative difference (MARD), 94.7% of results in the clinically accurate A region of the Clarke Error Grid and 95% of results meeting the accuracy criteria of the ISO 15197 standard. The proposed research is to modify the GluCath sensor for use in subcutaneous tissue. The objective of this phase I project is to demonstrate performance of a subcutaneous GluCath sensor in an animal model for 24 h. Subsequent phase II work will include the demonstration of safety and efficacy in extended duration human clinical studies and prototype development of miniaturized optical and electrical components and a suitable automated insertion device. PUBLIC HEALTH RELEVANCE: An estimated 3 million Americans have Type 1 diabetes. Continuous glucose monitors have been shown to provide significant therapeutic advantages, but current enzymatic sensor technologies have had limited clinical adoption and may not be sufficiently accurate for closed loop control. GluMetrics proposes to develop a novel and more accurate non-enzymatic based glucose sensor capable of achieving a high level of clinical accuracy over the entire physiological range (40 to 400 mg/dL), but especially in the hypoglycemic range (< 70 mg/dL).

描述（由申请人提供）：青少年糖尿病研究基金会（JDRF）估计，在美国多达300万人可能患有1型糖尿病。最近的大型临床试验已经证明了连续葡萄糖监测仪（CGMs）的治疗益处，从而增加了这些设备的保险报销的可用性。目前估计有50，000名糖尿病患者使用CGM，但随着胰岛素泵用户将其设备更换为具有集成CGM的下一代泵，预计采用率将稳步增长至250，000名用户。这意味着5亿美元的市场机会。然而，目前可用的CGMs具有技术缺陷，限制了近期广泛的临床应用和人工胰腺的长期进展。这些局限性包括低血糖范围的不准确性、频繁的校准要求和较长的导入时间。更重要的是，人工胰腺的最终成功商业化可能需要使用多个冗余传感器以确保安全。在这种情况下，使用非酶的冗余传感器可能具有显著的优点，即避免共模故障。 GluCath是一家风险投资支持的公司，开发GluCath血管内持续葡萄糖监测系统（GluCath系统）。该设备中的传感器使用通过光纤部署的新型猝灭荧光化学机制。GluCath系统设计用于接受强化胰岛素治疗的危重患者。在52例1型糖尿病健康志愿受试者中证明了临床可行性，持续时间长达24小时。在这些研究中，GluCath传感器被放置在手臂的外周静脉中，结果与参考葡萄糖分析仪非常一致，平均绝对相对差（MARD）为7.5%，94.7%的结果在Clarke误差网格的临床准确A区域内，95%的结果符合ISO 15197标准的准确度标准。 拟议的研究是修改GluCath传感器用于皮下组织。本I期项目的目的是证明皮下GluCath传感器在动物模型中的24小时性能。随后的第二阶段工作将包括在长期人体临床研究中证明安全性和有效性，以及小型化光学和电气组件以及合适的自动插入装置的原型开发。 公共卫生相关性：估计有300万美国人患有1型糖尿病。连续葡萄糖监测仪已显示出提供显著的治疗优势，但目前的酶传感器技术的临床应用有限，并且对于闭环控制可能不够准确。 Glucose提出开发一种新型的、更准确的非酶基葡萄糖传感器，其能够在整个生理范围（40至400 mg/dL）内实现高水平的临床准确度，但尤其是在低血糖范围（< 70 mg/dL）内。