維持適當的胰島素水平（Insulin Level）對糖尿病患者非常重要。研究指出，規律監測血糖可以維持體內胰島素水平，有效降低嚴重疾病及併發症的發生，進而改善死亡率發生的風險。然而，現有的血糖量測設備操作過程複雜且攜帶不便，降低了糖尿病患者進行自我監測血糖 （Self­Monitoring of Blood Glucose, SMBG) 的意願。
為了簡化血糖量測步驟以及改善攜帶的便利性，進而提高糖尿病患 者自我檢測血糖意願，本研究展示了一種新型的 SMBG 系統。此新型的SMBG 系統的最大特色是所設計出的整合型血糖檢測裝置（Integrated Detection Device for Blood Glucose, IDDBG) 中所有的組件均不含電子元件。該系統檢測原理是利用智慧型手機的光學感應相機模組對 IDDBG 裝置中的比色式的血糖試紙進行顏色差異性分析，所分析的數值利用智慧型手機中的血糖檢測應用程式轉換成血糖濃度值。
本研究與中國醫藥大學附設醫院合作，招募了 120 位來自不同年齡層的糖尿病患者參與臨床試驗，讓使用者親自操作 SMBG 系統量測血糖， 其數值將與 YSI­2300 血糖分析儀進行準確性比較，最後並針對易用性(usability) 進行問卷調查。其目的是為確認該新型 SMBG 系統的準確性能否符合 ISO15197:2013 規範以及了解是否有效改善糖尿病患檢測血糖操作及攜帶便利性。
從臨床實驗結果分析，三個不同批號的 IDDBG 裝置所得到的準確性數值分別為 97.43%–97.56% 之間，其結果符合 ISO 15197：2013 所規範準確度需 95% 以上要求。而一致性誤差網格 (Consensus Error Grid, CEG) 分析結果 100% 都落在 A 區（臨床準確區）和 B 區（臨床可接受區），其結果符合 CEG 要求。從問卷調查結果得知，使用者實際操作新型 SMBG 系統量測血糖後，有 97.5% 的使用者認為操作十分簡易，更有100% 的使用者認為該新型 SMBG 系統設計提升了攜帶便利性。
本研究設計結合智慧型手機檢測血糖是一種創新的 SMBG 系統，它簡化了血糖檢測的方法以及導入小型化的設計，達到操作及攜帶便利性之 功能，更重要的是擁有高準確性。此系統有助於提高糖尿病患者對血糖量測意願，更可以讓病患利用智慧型手機的多功能性達成行動醫療的目標。 關鍵字: 比色式試紙、血糖檢測設備、智慧型手機、臨床試驗

Maintaining appropriate insulin levels is very important for patients with diabetes. Studies have pointed out that regular monitoring of blood glucose can maintain appropriate insulin levels in the body, effectively reducing the occurrence of serious diseases and complications and the risk of mortality. Nevertheless, existing blood meters employ a series of complex steps for measuring the blood glucose level and are in­ convenient for carrying, which reduces the willingness of the diabetes patients to engage in the self­monitoring of blood glucose (SMBG).
To reduce the steps associated with measuring the blood glucose level, to improve portability, and to increase the willingness of the diabetes patients to engage in SMBG, a novel SMBG system is proposed in this study. The most important innovation with respect to SMBG is developing an integrated detection device for blood glucose (IDDBG), which does not contain electronic components. The novel SMBG system uses a smartphone with a camera to analyze the differences in the colorimetric blood strip of the IDDBG. These data are converted to the blood glucose level using a smartphone application.
This study was performed in collaboration with China Medical University Hospital, and 120 diabetes patients in different age groups were enrolled in a clinical trial study. These patients used the novel SMBG system to measure their blood glucose levels; the acquired data were compared with the results obtained using a YSI­2300 blood analysis instrument. Finally, a questionnaire survey was conducted for assessing the users’experience.
According to the analysis of the clinical trial results, the accuracy of the data measured using the novel SMBG system for three different lots was in the 97.43%–97.56% range, which is above the minimally acceptable 95% accuracy for the ISO 15197:2013 criteria. In addition, 100% of the results of the consensus error grid (CEG) analysis were in area A (clinical accuracy area) and area B (clinically acceptable area), meeting the CEG requirements. According to the analysis of the usability survey of the study participants who used the novel SMBG system for measuring their blood glucose levels, 97.5% of the participants felt that the operation was effortless, and 100% of the participants reported that the novel SMBG system had improved portability.
The system that uses a smartphone to detect blood glucose levels is an innovative SMBG system. It simplifies the blood glucose level determination and enables miniaturization for convenient operation and portability. More importantly, it has high accuracy. The proposed system can improve the willingness of the diabetes patients to engage in blood glucose self­monitoring and will enable patients to achieve the mHealth goal by utilizing the versatility of smartphones.

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