Accuracy of Newer-generation Home Blood Glucose Meter in Patients with IGR and Newly-diagnosed Type 2 Diabetes Mellitus_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Fang ¹ , LV Lifang ¹ , WANG Chun ¹ , YANG Yanzhi ¹ , HE Liping ¹ , LIU Guanjian ² , CHEN Dawei ¹ , ZHONG Li ³ , CHEN Lihong ¹ , TIAN Haoming ¹ , ZHOU Jian ⁴ , JIA Weiping ⁴ ,  RAN Xingwu 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. The Sixth People’s Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233,;

Corresponding author：

RAN Xingwu, Email: ranxingwu@yahoo.com.cn

Keywords：

Self-monitoring of blood glucose (SMBG); Glucose meter (ACCU-CHEK? Integra); Capillary blood glucose (CBG); Venous plasma glucose (VPG); Clarke Error Grid; Accuracy

DOI：

10.7507/1672-2531.20120085

Video：

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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.

Citation： WANG Fang,LV Lifang,WANG Chun,YANG Yanzhi,HE Liping,LIU Guanjian,CHEN Dawei,ZHONG Li,CHEN Lihong,TIAN Haoming,ZHOU Jian,JIA Weiping,RAN Xingwu. Accuracy of Newer-generation Home Blood Glucose Meter in Patients with IGR and Newly-diagnosed Type 2 Diabetes Mellitus. Chinese Journal of Evidence-Based Medicine, 2012, 12(5): 527-531. doi: 10.7507/1672-2531.20120085 Copy

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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.
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.
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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.	闻宜. 罗氏诊断推出新一代血糖仪—罗康全? 整合型血糖检测系统. 《中国医疗器械信息》, 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.

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. 闻宜. 罗氏诊断推出新一代血糖仪—罗康全? 整合型血糖检测系统. 《中国医疗器械信息》, 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.

Chinese Journal of Evidence-Based Medicine

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

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