Microneedle arrays for non-invasive continuous multianalyte sensing in diabetes

“用于糖尿病中的非侵入性连续多分析物感测的微针阵列” Electrozyme LLC 7.项目摘要 当前一代的连续葡萄糖监测器（CGM）被设计为经皮植入， 最多七天，之后佩戴者更换换能器。尽管目前的进展， 尽管这些设备具有分析优点，但CGMs仍然限于对单个分析物（葡萄糖）的定量， 相对较短的时间。然而，人们越来越认识到，适当的血糖管理 需要更全面的代谢功能检查血中的儿茶酚胺和酮 一些神经递质和代谢物的例子，可以增加标准血糖 测量，从而提供与患者血糖控制有关的信息的附加维度 和整体代谢健康。此外，换能器元件被替换的频率的降低 将进一步简化CGM的操作，并在患者的日常生活中提供增加的自主性。鉴于 鉴于目前CGMs的局限性，我们的团队最近率先开发了一种微创 包含具有多路复用传感元件的可寻址微针阵列的身体佩戴贴片。由于 该新颖的方法，其中电化学换能器嵌入在阵列的孔内， 通过使用中空微针，体上生物传感器能够直接在微针处执行各种生物分析功能。 微针-透皮流体接口，并且不需要复杂的微机电或微流体接口。 用于流体提取和分析的微流体系统。导电聚合物的新实现 提供了捕获生物识别元件的有效手段以及 赋予高度的渗透选择性，从而显著延长生物传感器的使用寿命， 的特异性此外，使用碳氟化合物糊剂减轻了 混淆了当前CGM解决方案中的准确血糖读数。按照项目 计划，研究工作旨在实现以下目标：（1）设计和制造的多分析物 微针阵列传感器平台，（2）表面固定和表面化学，以及（3）关键评价 的系统性能。拟议的第一阶段研究旨在扩展微针阵列概念 直到初步临床研究阶段，以便将这种实验室证明的技术转化为 一种商业产品，可作为170亿美元全球葡萄糖监测市场的主要竞争者 设备和人工胰腺系统。本提案中概述的技术和业务目标将 对基础研究和临床应用有直接影响，以提高目前的血糖状态 管理，从而改善糖尿病患者的福祉。

"Microneedle arrays for non-invasive continuous multianalyte sensing in diabetes" Electrozyme LLC 7. PROJECT SUMMARY The current generation of continuous glucose monitors (CGMs) are designed to be implanted transdermally for up to seven days after which the transducer is replaced by the wearer. Despite current advances in the analytical merits of these devices, CGMs are still limited to the quantification of a single analyte (glucose) over relatively short periods of time. However, it is increasingly recognized that proper glycemic management requires a more comprehensive examination of metabolic function. Blood catecholamines and ketones are some examples of neurotransmitters and metabolites that can augment standard blood glucose measurements, hence providing added dimensions of information pertaining to the patient's glycemic control and overall metabolic health. Moreover, a reduction in the frequency that the transducer element is replaced would further simplify the operation of CGMs and provide increased autonomy in the patient's routine. In light of the current limitations of CGMs, our team has recently pioneered the development of a minimally-invasive body-worn patch containing an addressable microneedle array with multiplexed sensing elements. Owing to the novel method in which the electrochemical transducer is embedded within the apertures of an array of hollow microneedles, the on-body biosensor is able to perform various bioanalytical functions directly at the microneedle-transdermal fluid interface and does not require sophisticated microelectromechanical or microfluidic systems for fluid extraction and analysis. The novel implementation of conducting polymers provides for both an effective means for the entrapment of the biorecognition element as well as the ability to impart a high degree of perm-selectivity, thereby dramatically extending the biosensor's useful lifetime and specificity. Furthermore, the utilization of a fluorocarbon paste mitigates the oxygen dependency that obfuscates accurate blood glucose readings among current CGM solutions. In accordance with the project plan, the research effort seeks to attain the following objectives: (1) design and fabrication of the multi-analyte microneedle array sensor platform, (2) surface immobilization and surface chemistry, and (3) critical evaluation of the system performance. The proposed Phase I research aims at extending the microneedle array concept up to the stage of preliminary clinical studies in order transform this laboratory-proven technology into a commercial product that can serve as a major contender in the USD $17B global market for glucose monitoring devices and artificial pancreas systems. The technology and business objectives outlined in this proposal will have a direct impact on basic research and clinical applications to enhance the current state of glycemic management and thereby will improve the well-being of the population with diabetes.