1 1 1 1 1 2 1 3 1 1 4 4 1* 1. 610041 2. 610041 3. 610100 4. 200233 ACCU-CHEK Integra Roche Diagnostics GmbH Germany impaired glucose regulation IGR 2 109 2 IGR oral glucose tolerance test OGTT ±2 min capillary blood glucose CBG venous plasma glucose VPG VPG median AD median RAD Clarke CBG VPG CBG VPG 292 CBG-VPG 93.49% CBG ISO median AD 7.2 mg/dl median RAD 4.76% 100% A B CBG VPG r=0.984 P=0.000 94.6% 95.7% Accuracy of Newer-generation Home Blood Glucose Meter in Patients with IGR and Newly-diagnosed Type 2 Diabetes Mellitus WANG Fang 1, LV Li-fang 1, WANG Chun 1, YANG Yan-zhi 1, HE Li-ping 1, LIU Guan-jian 2, CHEN Da-wei 1, ZHONG Li 3, CHEN Li-hong 1, TIAN Hao-ming 1, ZHOU Jian 4, JIA Wei-ping 4, RAN Xing-wu 1* 1. Department of Endocrinology and Metabolism, West China Hospital, Sichuan University, Chengdu 610041, China; 2. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China; 3. Department of Endocrinology and Metabolism, the First People's Hospital of Longquanyi District, Chengdu 610100, China; 4. Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, The Sixth People s Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China Abstract 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 SHDCl2006101 1968 Email: wangfangglj@163.com * Email: ranxingwu@yahoo.com.cn 527
Original Articles Chin J Evid-based Med 2012, 12(5): 527-531 degree of accuracy, and it can precisely report the real value of blood glucose. Key words Self-monitoring of blood glucose (SMBG); Glucose meter (ACCU-CHEK Integra); Capillary blood glucose (CBG); Venous plasma glucose (VPG); Clarke Error Grid; Accuracy [1,2] self monitoring of blood glucose SMBG SMBG 2 ROSSO SMBG 2 [3] 2005 SMBG [4] 2007 2009 [5] capillary blood glucose CBG venous plasma glucose VPG SMBG SMBG ACCU-CHEK Integra Roche Diagnostics GmbH Germany impaired glucose regulation IGR 2 oral glucose tolerance test OGTT ±2 min CBG VPG VPG SMBG 1 1.1 / 2 IGR 109 65 44 51.5±12.0 22 72 126.4±16.5/79.0±10.0 95 174/60 114 mmhg HbAlc 7.1±1.8 4.6 13.2TG 2.28±1.99 0.68 14.92 mmo/l TC 4.9±1.1 2.54 8.18 mmo/l BMI 24.72±3.05 17.7 33.3 kg/m 2 WHR 528 0.90±0.07 0.66 1.15 54 460.8 mg/dl 42.9%±4.4% 1 1.2 75 g 20 min 10 μl DDT VPG CBG 25 ±2 min VPG CBG-VPG D=CBG VPG RD= CBG VPG /VPG 100% AD RAD=AD/VPG 100% CBG-VPG CBG ISO 75 mg/dl <15 mg/dl >75 mg/dl ±20% [6] CBG / + 100% / + 100% / + 100% / + 100% 1.3 X±SD t SMBG [7,8] VPG CBG ±15 mg/dl ±20% mean difference MD median dif- 2012 Editorial Board of Chin J Evid-based Med
ference median D mean absolute difference MAD median absolute difference median AD mean absolute relative difference MARD median absolute relative difference median RAD VPG CBG Clarke VPG CBG α=0.01 α=0.05 CBG SPSS 13.0 2 109 292 VPG-CBG 3.8% 11 VPG 75 mg/dl 51.7% 151 VPG 76 180 mg/dl 44.5% 130 VPG>180 mg/dl 2.1 CBG VPG 109 292 VPG 54.0 460.8 mg/dl 1 CBG VPG P >0.05 75 mg/ dl CBG VPG r=0.313 76 460.8 mg/dl r=0.983 CBG VPG r=0.984 P=0.000 1 2.2 CBG 2 109 292 CBG-VPG VPG CBG median D= 1.80 mg/dl 95%CI 30.0 21.6 median AD 7.2 mg/dl median RAD 4.76% 93.49% CBG ISO VPG 75 mg/dl median AD 12.60 mg/dl VPG 76 120 mg/dl median RAD 6.38% VPG 121 180 mg/dl median RAD 5.52% VPG >180 mg/dl median RAD 3.60% 2.3 CBG VPG 292 CBG VPG VPG CBG Clarke 2 292 A B 277 95% A 15 5% B C D E 2.4 292 75 mg/dl n=11 1 CBG VPG VPG n VPG CBG P 292 172.68±74.10 172.79±72.92 0.984 0.895 75 11 71.18±6.15 79.53±13.12 0.313 0.053 76 180 151 121.32±30.78 123.63±34.41 0.932 0.098 >180 130 240.94±51.18 237.78±52.70 0.966 0.070 VPG CBG 1 CBG VPG 529
Original Articles Chin J Evid-based Med 2012, 12(5): 527-531 2 CBG VPG n MD Median D MAD Median AD MRAD Median RAD ISO 292 0.104±13.40 1.80 9.95±8.95 7.2 6.57±6.58 4.76 93.49 75 11 8.35±12.63 10.80 12.27±8.40 12.60 17.40±11.95 16.67 63.64 76 180 151 2.31±12.51 0.00 9.18±8.78 7.2 7.51±6.83 6.12 92.05 76 120 81 0.85±10.55 0.00 7.53±7.39 5.40 7.65±7.18 6.38 90.12 121 180 70 4.00±14.35 0.00 11.09±9.86 8.10 7.34±6.46 5.52 94.29 >180 130 3.16±13.72-3.96 10.65±9.16 9.00 4.57±4.15 3.60 99.23 2 CBG VPG Clarke >180 mg/dl 94.6% 95.7% 87.9% 95.7% 3 109 292 CBG VPG P>0.05 r 0.984 VPG CBG median D 1.80 mg/dl median AD 7.2 mg/dl median RAD 4.76% 93.49% CBG ISO Clarke 292 A B 95% A 5% B C D E FreeStyle Flash Abbott Diabetes Care Alameda CA One Touch Ultra Lifescan Milpitas CA [7,8] Meynaar [9] 32 CBG 239 CBG- r 0.939 94.1% ISO 11 mg/dl CBG VPG 75 mg/dl n=11 >180 mg/dl 94.6% 95.7% 87.9% 95.7% VPG 75 mg/dl r=0.313 VPG 530 2012 Editorial Board of Chin J Evid-based Med
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