2019-08-012024-05-15https://scholars.lib.ntu.edu.tw/handle/123456789/665130摘要：近年台灣各種慢性疾病的盛行率不斷地提高，且有年輕化之趨勢，而慢性疾病有賴長期的治療以減少相關併發症之產生，但多數患者參與治療的順從性(compliance)不高，使得治療效果與品質低下。因此，為解決糖尿病需長時間定時定量進行藥物注射或生理監測之需求，本整合型計畫預計研發一整合「微投藥系統」與「非侵入式生理感測器」之自主式微投藥系統，用以提高療效並降低整體醫療成本。在微投藥系統方面，我們將以先期研究中所初步發展的微投藥系統為基礎，進行藥物(胰島素在長時間(1周至1個月)持續精準微投藥(解析度10 nl/min)之自我偵測穩定性及應用有效性測試。而在非侵入式生理感測器之研發，將以隱形眼鏡為載具，設計製作一可長時間即時量測淚液中葡萄糖濃度之智慧型生理感測隱形眼鏡。因此，在計畫之第一年裡，將先以人體試驗來說明從淚液中葡萄糖濃度估算血糖之可靠性與準確性，預計透過約40名受試者(包含正常人與糖尿病患者)的各式體液(包含淚液、組織間液與血液)葡萄糖濃度之取樣與量測來證實此一可行性。預期將可大幅提升病患治療效果與品質，除可降低台灣整體之醫療成本，甚或可成為未來一般人居家自我健康照護以及早發現隱藏型慢性疾病之利器。第二年，則將透過在醫學院完成一連串糖尿病大鼠的胰島素治療實驗，來驗證本計畫所開發之微投藥系統之有效性與安全性。最後一年，將整合本計畫所自行開發之微投藥系統與血糖感測隱形眼鏡系統，以動物實驗進行閉迴路演算法之開發與測試，用以真正實現一人工胰臟，為此一自主式微投藥系統進行人體試驗前最佳之準備。此外，本計畫也將進行計畫所研發產品與現有市面售價高昂的注射幫浦與生理感測器做功能比較，以檢驗本計畫所發展系統之優勢與未來發展潛力，並期為台灣的精密醫療器材與檢測市場注入新的能量。<br> Abstract: n view of the increasing prevalence and morbidity of chronic diseases, such as diabetes, a regular drugs administration of subcutaneous injection of insulin are the most effective and direct therapy to reduce the complications of these diseases. However, the frequent drug application and potential risks of injection may result in low compliance of patients and thus decrease the therapeutic effectiveness. Therefore, to deal with this awkward situation, the development of a precision drug-delivery microsystem, integrated with a non-invasive physiological sensor for the measurement of blood glucose (BG), will be conducted to realize an autonomous drug-delivery microsystem in this project. In our preliminary works, a micropump system has been developed for delivering insulin to the diabetic rats. In this study, the flow stability and accuracy will be tested for a period of 1 week to 1 month with resolution of 10 nl/min dosing rate. Besides, the contact lens with physiological sensors will be developed for long-term and real time measurements of glucose concentration of tears. For verifying the reliability and accuracy of BG computation from tears, the clinical trials will be first conducted to study the glucose-level correlation of bio-fluids, including tears, interstitial fluid, and blood in the first year. With such biomedical contact lens patients or even healthy people could be beneficial for disease or health monitoring and diagnosis. In the second year, a series of animal tests of insulin therapy to diabetic rats will be conducted to verify the efficacy and safety of developed drug delivery system before clinical trials in the second year. This newly developed system brings the benefit in eliminating the low compliance of drug application and fear of regular and frequent subcutaneous injections, and thus could greatly enhance the therapeutic quality. In the final year, an artificial pancreas, consisting of self-developed drug delivery system and BG-detecting contact lens system, will be realized to study its closed-looped algorithm by animal tests before the clinical trials. Comparing the commercial products with the present autonomous drug-delivery system developed in the project, a bench mark test would be made at the end.糖尿病淚液血糖自主式微投藥系統非侵入式生理感測器血糖感測隱形眼鏡系統人工胰臟diabetestearsblood glucoseautonomous drug-delivery microsystemnon-invasive physiological sensorBG-detecting contact lens systemartificial pancreas