研究背景與目的：「低血糖體認障礙（Impaired Awareness of Hypoglycemia，IAH）」指的是糖尿病人感知血糖低下的能力不足，而IAH常會引起低血糖事件的發生，甚至是引發可能失去知覺的嚴重低血糖事件。台灣過去並未有研究探討社區第二型糖尿病人之IAH盛行率，缺乏合適的評估量表可能是原因之一。本研究旨在針對英文版Clarke method與Gold method之IAH量表進行中文化，並評估其信度、效度特徵；再使用中文版Clarke-TW與Gold-TW量表針對20歲以上接受胰島素注射或磺醯脲類口服藥物治療之臺南市第二型糖尿病個案進行方便抽樣與訪談，以評估社區糖尿病個案之IAH盛行狀況。此外，規律的自我監測血糖（Self-Monitoring of Blood Glucose，SMBG）可避免低血糖事件且對於糖尿病預後有正面的影響，本研究也將探討SMBG與IAH之間的相關性。

研究設計與方法：本研究首先組成雙語專家小組，利用翻譯–回譯程序進行英文版Clarke與Gold量表的中文化（分別稱Clarke-TW與Gold-TW）。之後招聘訪員（含社區藥師、診所醫事人員、衛生所人員）使用中文版Clarke-TW與Gold-TW量表於2022年8月26日至11月30日期間以橫斷性研究設計，在藥局、診所及衛生所等場域進行面對面訪談，完成898位20歲以上接受胰島素注射或磺醯脲類口服藥物治療之臺南市第二型糖尿病個案之收案作業。本研究將針對調查數據進行中文化量表之內部一致性、再測信度以及建構效度之驗證。後續根據調查數據測量社區糖尿病個案之IAH盛行率及95%信賴區間，並針對SMBG與IAH表現之相關性進行描述性、雙變量及多變量分析。

研究結果：本研究由雙語專家小組會議確認Clarke-TW與Gold-TW量表內容效度。Clarke-TW計有8個題目，內部一致性係數（Kuder-Richarson-20）為0.481；Clarke-TW與Gold-TW量表根據24名樣本計算1個月之再測信度係數（以Intra-class Correlation Coefficient表示）分別為0.660（p <0.001；95%CI：0.34-0.84）、0.653（p <0.001；95%CI：0.35-0.83）；此外，經由卡方檢定分析Clarke-TW與Gold-TW與性別（p=0.32、0.70）、受雇狀態（p=0.08、0.29）並無顯著相關；但與受訪者是否有自我血糖監測與一年內是否進行視網膜檢查，呈現顯著的相關性（p<0.001），可分別作為Clarke-TW與Gold-TW量表具有區別效度（Discriminant validity）與聚合效度（Convergent validity）之支持證據。因素分析也識別Clarke-TW具有2個構面，且主成分分析顯示模型配適度良好。本研究Clarke-TW與Gold-TW量表呈現的整體IAH盛行率分別36.1%（95%CI：32.9%-39.3%）及49.4%（95%CI：46.1%-52.3%），且口服磺醯脲類藥物個案之IAH盛行率均高於胰島素個案。Clarke-TW與Gold-TW量表所量測之IAH盛行情形，與最近3個月內有自我測量血糖（Clarke-TW：aOR：0.44，95% CI：0.38-0.51; Gold-TW：aOR：0.68，95% CI：0.63-0.73）、一年內有進行微量白蛋白檢查（Clarke-TW：aOR：0.63，95% CI：0.55-0.71; Gold-TW：aOR：0.51，95% CI：0.31-0.84）與視網膜檢查（Clarke-TW：aOR：0.43，95% CI：0.32-0.59; Gold-TW：aOR：0.32，95% CI：0.28-0.37）呈現顯著負相關性。這些結果傾向指出：SMBG較佳的個案，是IAH的保護因子。

結論：本研究所發展的Clarke-TW與Gold-TW量表是台灣第一個可用來評估IAH之工具，無論使用哪種量表，口服磺醯脲類藥物個案之IAH盛行率均高於胰島素個案，因此未來應針對使用口服磺醯脲類藥物個案加強提供低血糖認知之衛生教育與治療計畫。此外，本研究亦發現，若第二型糖尿病個案之SMBG行為較佳，如：最近3個月內有自我測量血糖、一年內曾進行微量白蛋白或視網膜檢查等，則其IAH之盛行率則是較低。本研究之結果可以做為未來在台灣社區進行第二型糖尿病個案篩檢IAH之工具以及介入對象之實證數據。

The aim of this study was to translate two English-version impaired awareness of hypoglycemia (IAH)questionnaires proposed by Clark and Gold, respectively into Chinese (i.e., Clarke-TW and Gold-TW), and to evaluate their reliabilities and validities. Chinese version of the Clarke-TW and Gold-TW have moderate level of test-retest reliability and satisfactory construct validity. From August to November 2022, a cross-sectional study was carried out on 898 people living with type 2 diabetes, aged >=20 years, treated with insulin injection or oral sulfonylureas, and invited to participate in the survey and completed face-to-face interviews at 19 pharmacies, clinics, or public health centers in Tainan. The overall IAH prevalence estimated from Clarke-TW and Gold-TW was 36.1% (95% CI：32.9%39.3%) and 49.4% (95%CI：46.1%52.3%). In addition, this study found that regardless of the Clarke-TW and Gold-TW scales, the prevalence of IAH in cases using oral sulfonylureas was higher than that in patients using insulin, which warrants more attention to those oral sulfonylureas users. This study also found that there was a correlation between IAH and Self-Monitoring of Blood Glucose (SMBG). Those who did not regularly self-monitor blood sugar or did not follow microalbumin and retinal examinations in the past year were more likely to have IAH. The health care workers should strengthen health education related to hypoglycemia, and develop appropriatee health educational materials or adapted interventions to increase the awareness of hypoglycemia of these high-risk groups.

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