【摘要】 目的 評價2型糖尿病（type 2 diabetes mellitus，T2DM）患者動態血糖監測（continuous glucose monitoring，CGM）的準確性及其相關因素。 方法 2009年1月—2010年1月共納入患者530例，其中口服降糖藥治療者和胰島素強化治療者各265例。應用動態血糖監測系統（美國Medtronic MiniMed公司）連續監測3 d，同時每天輸入4次指尖血糖值（self-monitoring of blood glucose，SMBG）進行校正。用直線回歸分析CGM值與SMBG的相關性，用Clarke誤差表格分析一致性，用平均絕對差（mean absolute relative difference，MAD）評價準確性，并分析MAD的相關因素。 結果 ①共收集到6 350對CGM值[（9.66±3.54） mmol/L]與SMBG值[（9.64±3.38） mmol/L]，兩者差異無統計學意義（Pgt;0.05）。Pearson相關性分析顯示，兩者呈正相關（r=0.959，Plt;0.001）。②Clarke誤差表格分析顯示:99.89%的點位于A區和B區，其中92.37%血糖值位于A區，7.72%位于B區，其余7對（0.11%）位于D區。③總體MAD值為7.2%（5.5%~9.5%），通過分析每天的MAD值見到，隨著監測時間的延長，CGM結果的MAD值逐漸降低，而準確性逐漸升高。 ④胰島素強化治療組患者MAD值高于口服藥治療組患者（Plt;0.05），多元逐步回歸分析顯示，MAD值與糖化血清白蛋白水平呈獨立負相關（β=-0.134， Plt;0.01），與胰島素強化治療呈獨立正相關（β=0.117， Plt;0.05）。 結論 ①動態血糖與毛細血管血糖具有良好的相關性、一致性及準確性。 ②CGM結果的準確性除了受監測時間的影響外，還可能與患者的降糖治療方案有關。【Abstract】 Objective To assess the accuracy of continuous glucose monitoring (CGM) for patients with type 2 diabetes mellitus (T2DM), and its correlated factors. Methods From January 2009 to January 2010, 530 patients with T2DM were enrolled in this study, including 265 subjects taking oral hypoglycemic agents and the other 265 subjects taking intensive insulin treatment. All the subjects underwent CGM (American Medtronic MiniMed) for three days. Meanwhile, capillary glucose values through self-monitoring of blood glucose (SMBG) were inputted four times a day for adjustment. The correlation of CGM value and capillary glucose value was analyzed by linear regression method. The consistency was analyzed by Clarke error grid. Mean absolute relative difference (MAD) was used to assess accuracy and correlated factors of MAD were also analyzed. Results ① A total of 6 350 pairs of CGM and SMBG values were collected [(9.66±3.54) mmol/L vs. 9.64±3.38) mmol/L,Pgt;0.05]. Pearson correlation analysis showed that CGM value was positively correlated with SMBG value (r=0.959,Plt;0.001). ② Clarke error grid demonstrated that 99.89% of paired SMBG-CGM values were located in zone A and zone B and the remaining seven pairs (0.11%) of glucose values were located in zone D. ③ The overall MAD value was 7.2% (5.5%-9.5%). According to the analysis of daily MAD value, MAD value decreased, while accuracy elevated gradually with monitoring time. ④ MAD value of intensive insulin treatment group was higher than that of the oral hypoglycemic agent treatment group (Plt;0.05). And stepwise multiple regression analysis indicated that MAD value had negative correlation with glycated albumin level (β=-0.134, Plt;0.01) and positive correlation with intensive insulin treatment (β= 0.117,Plt;0.05). Conclusions ① The results of CGM are accurate, and have good correlation and consistency with capillary glucose. ② Besides monitoring time, the accuracy of continuous glucose monitoring may be also associated with hypoglycemic treatment strategy.
Objective To evaluate the accuracy of newer-generation home blood glucose meter (Accu-Check? Integra) in patients with impaired glucose regulation (IGR) and newly-diagnosed type 2 diabetes mellitus. Methods A cross-sectional study was performed on 109 cases with newly-diagnosed type 2 diabetes or IGR who were asked to take oral glucose tolerance test (OGTT), while paired samples, that were Accu-Check? Integra in capillary blood glucose (CBG) and laboratory glucose in venous plasma glucose (VPG ), were taken simultaneously. Taking VPG as the reference value, the accuracy of the home glucose meter was assessed according to the international standardization organization (ISO), including, the accuracy was studied by means of Median absolute difference (Median AD) and Median absolute relative difference (Median RAD), the consistency of CBG and VPG was studied by Clarke Error Grid analysis, the correlation of CBG and VPG was analyzed according to liner regression analysis, and the sensitivity and specificity for hyperglycemia were also calculated. Results There were 292 VPG values paired with CBG values, among which 93.49% of CBG values met ISO home glucose meter criteria, the median AD was 7.2 mg/dL, and the median RAD was 4.76%. Paired glucose measurements from the Accu-Check Integra meter and laboratory glucose measurement demonstrated that 100% of paired points in the overall subject population fell in zones A and B of the Clarke Error Grid. The CBG value was well correlated to VPG value in the overall level, and the sensitivity and specificity were 94.6% and 95.7% respectively for hyperglycemia. Conclusion The newer-generation home blood glucose meter (Accu-Check? Integra) demonstrates a high degree of accuracy, and it can precisely report the real value of blood glucose.