新一代羅康全整合型血糖儀的準確度分析_《中國循證醫學雜志》

作者：

王芳 ¹ , 呂麗芳 ¹ , 王椿 ¹ , 楊閻峙 ¹ , 何利平 ¹ , 劉關鍵 ² , 陳大偉 ¹ , 鐘莉 ³ , 陳利鴻 ¹ , 田浩明 ¹ , 周健 ⁴ , 賈偉平 ⁴ ,  冉興無 ¹

1. 四川大學華西醫院內分泌代謝科（成都 610041）；2. 四川大學華西醫院中國循證醫學中心（成都 610041）；3. 成都市龍泉驛區第一人民醫院內分泌科（成都 610100）；4. 上海交通大學附屬第六人民醫院內分泌代謝科，上海市糖尿病研究所，上海市糖尿病臨床醫學中心（上海 200233）;

關鍵詞：

自我血糖檢測羅康全整合型血糖檢測儀指尖毛細血管血糖靜脈血漿血糖誤差表格分析準確度

DOI：

10.7507/1672-2531.20120085

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目的　評價新一代自我血糖檢測儀——羅康全整合型血糖儀（ACCU-CHEK? Integra，Roche Diagnostics GmbH，Germany）在糖調節受損（impaired glucose regulation，IGR）和初發2型糖尿病患者自我血糖檢測中的準確度。
方法　采用橫斷面研究的方法，對109例初發2型糖尿病或IGR患者進行口服葡萄糖耐量試驗（oral glucose tolerance test，OGTT）的同時，在±2 min內用羅康全整合型血糖儀測定指尖毛細血管血糖，而后比較毛細血管血糖（capillary blood glucose，CBG）和靜脈血漿血糖（venous plasma glucose，VPG）數值差異，以VPG為參考值，評價該血糖儀的準確度。用絕對差值的中位數（median AD）、絕對差值的相對數的中位數（median RAD）評價其準確度；用Clarke誤差表格分析指尖血CBG和VPG的一致性；用線性回歸方法分析CBG值與VPG值的相關性；用敏感度、特異度評估血糖儀對高血糖檢測的準確度和特異度。
結果　共收集到292對CBG-VPG值。93.49%的CBG值符合ISO家用血糖儀檢測標準，median AD為7.2 mg/dL，median RAD為4.76%；誤差表格分析顯示100%位于A區和B區；CBG值與VPG值在整體水平上具有較好的相關性（r=0.984，P=0.000），檢測高血糖的敏感度和特異度分別為94.6%和95.7%。
結論　羅康全整合型血糖儀具有良好的準確度，能較準確地反映血糖的真實水平。

引用本文： 王芳,呂麗芳,王椿,楊閻峙,何利平,劉關鍵,陳大偉,鐘莉,陳利鴻,田浩明,周健,賈偉平,冉興無. 新一代羅康全整合型血糖儀的準確度分析. 中國循證醫學雜志, 2012, 12(5): 527-531. doi: 10.7507/1672-2531.20120085 復制

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2.	Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet, 1998, 352(9131): 837-853.
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7.	Diabetes Research in Children Network (DIRECNET) Study Group. The accuracy of the CGMS in children with type 1 diabetes: results of the diabetes research in children network (DirecNet) accuracy study. Diabetes Technol Ther, 2003, 5(5): 781-789.
8.	Weinzimer SA, Beck RW, Chase HP, et al. Accuracy of newer-generation home blood glucose meters in a Diabetes Research in Children Network (DirecNet) inpatient exercise study. Diabetes Technol Ther, 2005, 7(5): 675-680.
9.	Meynaar IA, van Spreuwel M, Tangkau PL, et al. Accuracy of AccuChek glucose measurement in intensive care patients. Crit Care Med, 2009, 37(10): 2691-2696.
10.	Kost GJ, Tran NK, Abad VJ, et al. Evaluation of point-of-care glucose testing accuracy using locally-smoothed median absolute difference curves. Clin Chim Acta, 2008, 389(1-2): 31-39.
11.	Velazquez FR, Bartholomew D. Effect of small sample volume on five glucose monitoring systems. Diabetes Care, 1996, 19(8): 903-904.
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13.	Kazlauskaite R, Soni S, Evans AT, et al. Accuracy of self-monitored blood glucose in type 2 diabetes. Diabetes Technol Ther, 2009, 11(6): 385-392.

1. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med, 1993, 329(14): 977-986.
2. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet, 1998, 352(9131): 837-853.
3. Martin S, Schneider B, Heinemann L, et al. Self-monitoring of blood glucose in type 2 diabetes and long-term outcome: an epidemiological cohort study. Diabetologia, 2006, 49(2): 271-278.
4. Bergenstal RM, Gavin JR 3rd; Global Consensus Conference on Glucose Monitoring Panel. The role of self-monitoring of blood glucose in the care of people with diabetes: report of a global consensus conference. Am J Med, 2005, 118(Suppl 9A): 1S-6S.
5. Zhou J, Li H, Ran X, et al. Reference values for continuous glucose monitoring in Chinese subjects. Diabetes Care, 2009, 32(7): 1188-1193.
6. International Organization for Standardization: In Vitro Diagnostic Test Systems—Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus. Geneva: Switzerland, 2003.
7. Diabetes Research in Children Network (DIRECNET) Study Group. The accuracy of the CGMS in children with type 1 diabetes: results of the diabetes research in children network (DirecNet) accuracy study. Diabetes Technol Ther, 2003, 5(5): 781-789.
8. Weinzimer SA, Beck RW, Chase HP, et al. Accuracy of newer-generation home blood glucose meters in a Diabetes Research in Children Network (DirecNet) inpatient exercise study. Diabetes Technol Ther, 2005, 7(5): 675-680.
9. Meynaar IA, van Spreuwel M, Tangkau PL, et al. Accuracy of AccuChek glucose measurement in intensive care patients. Crit Care Med, 2009, 37(10): 2691-2696.
10. Kost GJ, Tran NK, Abad VJ, et al. Evaluation of point-of-care glucose testing accuracy using locally-smoothed median absolute difference curves. Clin Chim Acta, 2008, 389(1-2): 31-39.
11. Velazquez FR, Bartholomew D. Effect of small sample volume on five glucose monitoring systems. Diabetes Care, 1996, 19(8): 903-904.
12. 聞宜. 羅氏診斷推出新一代血糖儀—羅康全? 整合型血糖檢測系統. 《中國醫療器械信息》, 2006, 12(11): 66.
13. Kazlauskaite R, Soni S, Evans AT, et al. Accuracy of self-monitored blood glucose in type 2 diabetes. Diabetes Technol Ther, 2009, 11(6): 385-392.

《中國循證醫學雜志》

新一代羅康全整合型血糖儀的準確度分析

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《中國循證醫學雜志》

新一代羅康全整合型血糖儀的準確度分析

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