Accuracy of Newer-generation Home Blood Glucose Meter in Patients with IGR and Newly-diagnosed Type 2 Diabetes Mellitus

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1 * ACCU-CHEK Integra Roche Diagnostics GmbH Germany impaired glucose regulation IGR 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= % 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 , China; 2. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu , China; 3. Department of Endocrinology and Metabolism, the First People's Hospital of Longquanyi District, Chengdu , China; 4. Department of Endocrinology and Metabolism, Shanghai Clinical Center for Diabetes, The Sixth People s Hospital Affiliated to Shanghai Jiaotong University, Shanghai , 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 SHDCl wangfangglj@163.com * ranxingwu@yahoo.com.cn 527

2 Original Articles Chin J Evid-based Med 2012, 12(5): 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] [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 / 2 IGR ± ±16.5/79.0± / mmhg HbAlc 7.1± TG 2.28± mmo/l TC 4.9± mmo/l BMI 24.72± kg/m 2 WHR ± mg/dl 42.9%±4.4% 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 Editorial Board of Chin J Evid-based Med

3 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 VPG-CBG 3.8% 11 VPG 75 mg/dl 51.7% 151 VPG mg/dl 44.5% 130 VPG>180 mg/dl 2.1 CBG VPG VPG mg/dl 1 CBG VPG P > mg/ dl CBG VPG r= mg/dl r=0.983 CBG VPG r=0.984 P= CBG CBG-VPG VPG CBG median D= 1.80 mg/dl 95%CI median AD 7.2 mg/dl median RAD 4.76% 93.49% CBG ISO VPG 75 mg/dl median AD mg/dl VPG mg/dl median RAD 6.38% VPG mg/dl median RAD 5.52% VPG >180 mg/dl median RAD 3.60% 2.3 CBG VPG 292 CBG VPG VPG CBG Clarke A B % A 15 5% B C D E mg/dl n=11 1 CBG VPG VPG n VPG CBG P ± ± ± ± ± ± > ± ± VPG CBG 1 CBG VPG 529

4 Original Articles Chin J Evid-based Med 2012, 12(5): CBG VPG n MD Median D MAD Median AD MRAD Median RAD ISO ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± > ± ± ± CBG VPG Clarke >180 mg/dl 94.6% 95.7% 87.9% 95.7% CBG VPG P>0.05 r 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 % 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 Editorial Board of Chin J Evid-based Med

5 75 mg/dl median AD mg/dl 63.64% ISO Kost [10] FreeStyle Flash Abbott Diabetes Care Alameda CA One Touch Ultra Lifescan Milpitas CA [7,8] VPG 70 mg/dl median AD 5 mg/dl 99% 96% ISO n=11 75 mg/dl 17% 79% [11] 30% 1.5 μl [12] P>0.05 [13] 17 [12] 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): 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): 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): International Organization for Standardization: In Vitro Diagnostic Test Systems Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus. Geneva: Switzerland, 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): 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): Meynaar IA, van Spreuwel M, Tangkau PL, et al. Accuracy of AccuChek glucose measurement in intensive care patients. Crit Care Med, 2009, 37(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): Velazquez FR, Bartholomew D. Effect of small sample volume on five glucose monitoring systems. Diabetes Care, 1996, 19(8): , 2006, 12(11): Kazlauskaite R, Soni S, Evans AT, et al. Accuracy of self-monitored blood glucose in type 2 diabetes. Diabetes Technol Ther, 2009, 11(6): 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):