Long-term Luminescence-based Glucose Monitoring

长期发光血糖监测

• 批准号: 8332320
• 负责人: Natalie Ann Wisniewski
• 金额: $ 48.7万
• 依托单位: PROFUSA, 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 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8332320
• 关键词: Adoption; Affect; Animals; Artificial Pancreas; Back; Biosensor; Blood Glucose; Blood capillaries; Calibration; Chronic; Chronic Disease; Clinical; Color; Complex; Diabetes Mellitus; Disease; Expenditure; Failure; Family suidae; Film; Foreign Bodies; Fright; Glucose; Goals; Grant; Healthcare; Healthcare Systems; Hydrogels; Hypoglycemia; In Vitro; Individual; Injectable; Lead; Length; Life; Light; Measures; Metric; Modeling; Monitor; Nanosphere; Noise; Optical Readers; Optics; Patients; Phase; Production; Quality of life; Reader; Reading; Signal Transduction; Skin; Small Business Innovation Research Grant; Syringes; System; Technology; Testing; Time; Tissues; Translations; base; burden of illness; capillary; commercial application; compliance behavior; density; design; diabetic patient; experience; glucose monitor; glucose sensor; implanted sensor; improved; in vivo; luminescence; meetings; miniaturize; novel; prototype; response; scaffold; sensor; tool

DESCRIPTION (provided by applicant): Currently available continuous glucose sensors are inaccurate and prone to failure, making the goal of an artificial pancreas elusive. Furthermore, their designs are not patient-friendly and they require frequent user input (e.g. calibration). The largest hurdle in developing implantable glucose sensors is the foreign body response (FBR). In this Phase I SBIR, we propose a syringe-injectable, tissue-integrating, glucose sensor to mitigate the foreign body response and enable accurate glucose monitoring for a minimum of 3 weeks in the body. PROFUSA's long- term goal is to develop a self-calibrating, implantable CGM with a minimum operational life of 3 months and a longer-term goal of 12 months that will be sufficiently accurate so as to enable an artificial pancreas. Tiny, soft and porous tissue-integrating biosensors that encourage capillaries to grow in and throughout the entire cross section of the sensor are being developed to allow reliable sensor function and thus overcome limitations of the FBR. Prototype sensors will be produced by integrating luminescent sensing nanospheres (glucose-responsive and reference nanospheres) into previously developed vascularizing hydrogel scaffolds (developed by PROFUSA and collaborators through currently active grants). The near infrared sensor signals are read through the skin with a miniaturized Continuous Optical INterrogation (COIN) patch reader that utilizes novel micro-optics to significantly decrease background noise. The goal of this Phase I SBIR is to demonstrate in vivo sensor functionality with the sensor and reader prototypes. Advancements towards a thin-film patch reader that will continuously and discretely monitor blood glucose will improve patient compliance. Clinical translation of this technology will motivate and enable diabetic patients to more tightly control their glucose levels without fear of hypoglycemia, and will reduce the diabetes disease burden on the healthcare system.

描述（由申请人提供）：目前可用的连续葡萄糖传感器不准确且容易失效，使得人工胰腺的目标难以实现。此外，它们的设计对患者不友好，并且需要频繁的用户输入（例如校准）。开发植入式葡萄糖传感器的最大障碍是异物反应（FBR）。在这个I期SBIR中，我们提出了一种可注射的、组织整合的葡萄糖传感器，以减轻异物反应，并在体内至少3周内实现准确的葡萄糖监测。PROFUSA的长期目标是开发一种自校准、可植入的CGM，其最低使用寿命为3个月，长期目标为12个月，并将足够精确，从而实现人工胰腺。微小、柔软和多孔的组织集成生物传感器正在开发中，它可以促进毛细血管在传感器的整个横截面中生长，从而实现可靠的传感器功能，从而克服FBR的局限性。原型传感器将通过将发光传感纳米球（葡萄糖响应纳米球和参考纳米球）集成到先前开发的血管化水凝胶支架（由PROFUSA及其合作者通过当前有效的资助开发）中来生产。近红外传感器信号通过一个小型化的连续光学询问（COIN）贴片读取器读取，该贴片读取器利用新型微光学来显着降低背景噪声。第一阶段SBIR的目标是用传感器和读取器原型演示体内传感器功能。薄膜贴片读取器的进步，将持续和离散监测血糖，将提高患者的依从性。该技术的临床转化将激励并使糖尿病患者能够更严格地控制血糖水平，而不必担心低血糖，并将减轻医疗保健系统的糖尿病疾病负担。