A Hybrid Continuous Glucose and Lactate Monitor with Improved Signal Reliability

具有更高信号可靠性的混合连续血糖和乳酸监测仪

• 批准号: 10292461
• 负责人: Jared Rylan Tangney
• 金额: $ 29.93万
• 依托单位: BIOLINQ INCORPORATED
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10292461
• 关键词: Apple; Archives; Biosensor; Blood Glucose; Bluetooth; Buffers; Businesses; Caliber; Characteristics; Chemistry; Clinical; Clinical Research; Communities; Custom; Data Display; Databases; Dermal; Dermis; Detection; Development; Devices; Diabetes Mellitus; Dimensions; Dose; Effectiveness; Elements; Ensure; Evaluation; Generations; Glucose; Glucose Plasma Concentration; Height; Hormones; Hour; Hybrids; Hypoglycemia; In Vitro; Individual; Insulin; Insulin-Dependent Diabetes Mellitus; Intercellular Fluid; Lead; Life; Location; Measurement; Measures; Monitor; Nature; Noise; Oxidases; Pain-Free; Patients; Performance; Phase; Phosphate Buffer; Physical activity; Physiologic pulse; Physiological; Property; Reading; Reporting; Research; Resolution; Safety; Sampling; Secure; Signal Transduction; Skin; Sterility; Sterilization; Surface; System; Systems Development; Technology; Time; Transducers; Translating; Validation; Wireless Technology; Work; base; biomaterial compatibility; circulating biomarkers; cloud based; commercialization; cost; design; detection limit; diabetes management; glucose monitor; improved; individual variation; insight; miniaturize; mobile application; monitoring device; next generation; novel; rate of change; response; sensor

"A hybrid continuous glucose and lactate monitor with improved signal reliability" Biolinq Inc. (f/k/a Electrozyme LLC) 7. PROJECT SUMMARY Over the past decade, the diabetes community has benefited enormously from the successful commercialization of multiple generations of continuous glucose monitors (CGMs). These devices are able to report readings of glucose in the interstitial fluid (ISF) to users on a near real-time basis. Over the few years, driven primarily by demands for improved glycemic management in insulin-dependent diabetes, the accuracy and reliability of CGM devices made further advances leading to FDA approval of their use in determining insulin dosing without the need for confirmatory fingersticks. The latest generation of CGM devices are routinely used to provide input to automated insulin delivery (AID) systems. However, despite these impressive improvements in CGM technology, CGMs today remain limited to the measurement of a single analyte and lack the ability to take redundant measurements. It is increasingly recognized that further advances in glycemic management will likely require the addition of other circulating biomarkers to elucidate individual variability in glycemic response, especially to physical activity. Measurement of freely circulating lactate can augment established glucose measurements as lactate has been found to shift glycemic thresholds for hypoglycemia in individuals with T1D to lower plasma glucose concentrations [33]. This project thus aims to provide a novel CGM platform capable of accurately measuring both glucose and lactate. We believe that a combined glucose and lactate continuous monitoring system will enhance the safety and efficacy of the next generation of AID systems. Biolinq has developed a body-worn patch containing a microneedle array with multiplexed sensing elements. Clinical studies to date have used a microneedle array consisting of individually-addressable microneedles inserted into the reticular dermis – approximately 200 to 350 microns below the surface of the skin. Previous work has shown a high level of correlation between glucose in the dermal interstitial fluid and blood glucose [57]. Our clinical studies have confirmed the high level of correlation reported and low lag time previously established for glucose in the dermal ISF [36]; we believe this is a unique property of sensing in the dermis and can be extended to other metabolites. In accordance with the project plan, the research effort seeks to attain the following objectives: (1) development and refinement of a lactate-selective sensing chemistry and its co-location with Biolinq’s clinically-validated glucose-selective chemistry, (2) implementation of redundant measures of glucose and lactate in a microneedle array sensor platform featuring individually-addressable sensing elements to provide accurate and reliable measurements in the dermal ISF, and (3) design of an end-to-end body-worn sensing system containing a miniaturized, low-power application-specific integrated circuit with Bluetooth wireless capability. The technology and business objectives outlined in this proposal will have a direct impact on open- and closed-loop insulin delivery and should meet current needs for an accurate, non-invasive continuous glucose and lactate monitor with broad applicability owing to its enhanced reliability, accuracy, simple use profile, and low-cost nature.

“杂化连续葡萄糖和带有提高信号可靠性的葡萄糖监测器” Biolinq Inc.（F/K/A Eleprozyme LLC） 7。项目摘要 在过去的十年中，糖尿病社区从成功的商业化中受益匪浅 连续葡萄糖监测器（CGM）的多代。这些设备能够报告 葡萄糖在间隙流体（ISF）中以接近实时的方式向用户提供给用户。在几年中，主要驱动 对胰岛素依赖性糖尿病的血糖管理的需求，CGM的准确性和可靠性 设备进一步进步，导致FDA批准其在没有胰岛素剂量的情况下使用 需要确认指尖。最新一代CGM设备通常用于提供输入 自动胰岛素输送（AID）系统。但是，多皮特这些CGM技术的这些令人印象深刻的改进， 今天的CGMS仍然仅限于单个分析物的测量，并且缺乏冗余的能力 测量。人们越来越认识到，血糖管理的进一步进步可能需要 添加其他循环生物标志物以阐明血糖反应中的个体变异性，尤其是对 体育锻炼。游离循环乳酸的测量可以增强已建立的葡萄糖测量值 已经发现鞋底会转移T1D个体低血糖的血糖阈值降低血浆 葡萄糖浓度[33]。因此，该项目旨在提供一个能够准确的CGM平台 测量葡萄糖和乳酸。我们认为，葡萄糖和乳酸连续监测 系统将提高下一代辅助系统的安全性和效率。 Biolinq开发了 包含具有多重灵敏度元素的微针阵列的身体饰面斑块。迄今为止的临床研究 使用的微针阵列由插入网状真皮中的可添加的微针组成 - 在皮肤表面以下约200至350微米。以前的工作显示了高水平 皮肤间质液与血糖中的葡萄糖之间的相关性[57]。我们的临床研究有 确认了先前在皮肤中葡萄糖建立的高水平相关性和低滞后时间 ISF [36];我们认为，这是真皮中传感的独特属性，可以扩展到其他代谢物。 根据项目计划，研究工作旨在实现以下目标：（1）发展 并改进了鞋底选择性感应化学及其与Biolinq临床验证的共同点 葡萄糖选择性化学，（2）实施微针中的葡萄糖冗余度量 阵列传感器平台具有可爱的传感器元素，可提供准确可靠 皮肤ISF中的测量以及（3）设计端到端的磨损感应系统，该系统包含一个 具有蓝牙无线功能的微型，低功率应用特定的集成电路。技术 该提案中概述的业务目标将直接影响开环胰岛素和闭环胰岛素 交付，应满足当前的需求，以实现准确，无创的连续葡萄糖和裂缝监测器 由于其增强的可靠性，准确性，简单的使用配置文件和低成本性质，因此具有广泛的适用性。