研究生: |
陳建志 Chen, Chien-Chih |
---|---|
論文名稱: |
預防糖尿病患併發疾病發生之臨床評估研究 The studies of clinical evaluation for prevention of complications in diabetes mellitus |
指導教授: | 黎耀基 |
口試委員: |
張大慈
韋建華 朱基銘 李文權 黎耀基 |
學位類別: |
博士 Doctor |
系所名稱: |
生命科學暨醫學院 - 生物科技研究所 Biotechnology |
論文出版年: | 2012 |
畢業學年度: | 101 |
語文別: | 英文 |
論文頁數: | 103 |
中文關鍵詞: | 血糖機系統 、糖尿病 、精確度分析 、變異係數 、不同分析部位 、血液體積偵測技術 、干擾物質 |
相關次數: | 點閱:2 下載:0 |
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具高準確性血糖機系統能夠提升糖尿病患自我管理能力並防止併發症發生。本研究中評估了三款新研發血糖機系統的臨床表現,相關性分析和迴歸性分析結果發現新研發血糖機系統與標準分析儀參考值相關性良好,Error Grid分析結果發現新研發血糖機系統100%測試值均落於可接受區域,故建議三款新研發血糖機系統在臨床上應皆為可接受之測定儀。三款新研發血糖機系統有些測試值與標準參考值差異大於20% 比率,分別為2.48%, 1.82% 和2.16%,符合ISO 15197小於5% 標準。在精確度分析方面,雖然在低血糖濃度時,其中一款新研發血糖機系統有較高的變異係數,但三款新血糖機系統於血糖濃度高於50 mg/dl狀況下,變異係數均低於5%。Error grid分析結果發現,受訓練過操作者與病患執行新血糖機系統,所得數值並無明顯差異;由於降低測試者技術條件的依賴,可預期病患使用此系統將得到接近於受訓練過操作者的精確度。和不同分析部位比較,指尖分析部位分析結果與手掌、小指球、前臂分析部位與靜脈血分析結果相關性良好。分析結果顯示,指尖分析部位、手掌分析部位、小指球分析部位與前臂分析部位分析結果落於可接受區域達100%。 97% 病患認為不同部位採血較傳統指尖部位採血疼痛感較輕,所以教導如何運用不同部位採檢分析血糖,將有效增加糖尿病患每日監測血糖次數。血液體積偵測技術提供病患對系統正確使用有了更好的指示,並將改善血糖機系統準確性與可信賴度。此系統使用了酵素法,且不受許多干擾物質影響;在10,000英呎海拔高度,葡萄糖脫氫酶精確度表現比葡萄糖氧化酶佳。病患可以因本研究了解認識這些干擾物質並採取減少它們影響的措施,本研究也提供技術人員更加了解準確性研究模式,並可建議改善臨床實務上血糖機系統準確度的相關事項。預期本研究能對於糖尿病併發症藥物開發、篩檢儀器及試劑研究開發將提供貢獻與助益。
The self-monitoring blood glucose system (SMBGS) with high accuracy can enhance self-management of diabetes to prevent the complications of diabetes. The study evaluated the clinical performance of three newer SMBGS. Correlation and regression analysis showed that newer SMBGS readings correlated excellently with the gold-standard reference values. The Error Grid analysis showed that measurements deemed clinically acceptable approach 100% and suggested newer SMBGS are clinically acceptable devices. Three newer SMBGS had a few specimens value different from reference method by more than 20% (2.48%, 1.82%, 2.16%, respectively), meeting the ISO 15197 criteria (<5%). The coefficients of variation of three newer SMBGS were less than 5% at glucose concentration greater than 50mg/dl, although one of the SMBGS had a greater level of imprecision in the hypoglycemic range. Error grid analysis also indicated that no considerable reading differences were observed between the trained operator and the patients who performed newer SMBGS. Owing to their reduced dependence on tester technique, patients using these system are expected to achieve a level of accuracy and precision similar to trained operator. As compared to the alternate site, the fingertip correlated well with the thenar, hypothenar, forearm. and venous blood value. The Clarke error grid analysis indicated that the results of fingertip and alternative sites were clinically acceptable approach 100%. A majority of patients (97%) stated that the collection of blood from the alternate sites induced less pain than the classic sites. Being instructed on how to use the alternate sites, patients will increase the frequency of daily testing. The novel technique of blood volume detection can provide patients with a superior indication to use the system and improve the reliability and accuracy of SMBGS. The systems used enzymatic methods and were unaffected by several interference. The glucose dehydrogenase performed better than glucose oxidase at 10,000 ft altitude. Patients can recognize interference and take steps to minimize their impact. These researches also provide clinicians with a better understanding of accuracy studies and suggesting what can be done to improve the accuracy of SMBGS in clinical practice. It is expected that these researches can contribute to drug discovery, screening instrumentation or reagents R & D for complications of diabetes mellitus.
1. A. Albright, What is public health practice telling us about diabetes? J Am Diet Assoc. 2008; 108: S12–8.
2. A. Brown, L .R. Reynolds, D. Bruemmer. Intensive glycemic control and cardiovascular disease: an update. Nat Rev Cardiol. 2010 Jul; 7(7): 369-75.
3. ADA Consensus Development Panel, Consensus statement on self-monitoring of blood glucose. Diabetes Care .1987; 10: 95–9.
4. ADA Position Statement, Office guide to diagnosis and classification of diabetes mellitus and other categories of glucose intolerance. Diabetes Care .1993; 16 : 4.
5. A.D. Deshpande, M. Harris-Hayes , M .Schootman. Epidemiology of diabetes and diabetes-related complications. Phys Ther. 2008 Nov; 88(11): 1254- 64.
6. A.E. Cass , G. Davis, G.D. Francis, H.A. Hill, W.J. Aston, I.J. Higgins, E.V. Plotkin, L.D. Scott, and A.P. Turner. Ferrocene-mediated enzyme electrode for amperometric determination of glucose, Anal Chem. 1984; 56 (4): 667- 71.
7. A.E.G. Cass et al. Turner, Ferrocene-mediated enzyme electrode for amperometric determination of glucose. Anal Chem.1984; 56: 667.
8. A. Fagot-Campagna, D.J. Pettitt, M.M. Engelgau, N.R. Burrows, L.S. Geiss, R. Valdez. G. Beckles, J. Saaddine, E.W. Gregg, D.F. Williamson, K.M.V. Narayan, Type 2 diabetes among North American children and adolescents: an epidemiological review and a public health perspective. J. Pediatr. 2000; 136: 664– 72.
9. A. Garg .Treatment of diabetic dyslipidemia. Am J Cardiol. 1998 Feb 26; 81 (4A): 47B- 51B.
10. A. Grimaldi . A. Heurtier. Epidemiology of cardio-vascular complications of diabetes. Diabetes Metab. 1999 Jun; 25 Suppl 3:12- 20..
11. A. Heller, B. Feldman. Electrochemical glucose sensors and their applications in diabetes management. Chem. Rev. 2008; 108: 2482– 505.
12. A. H. Barnett, A. J. Krentz, K. Strojek, et al. The efficacy of self-monitoring of blood glucose in the management of patients with type 2 diabetes treated with a gliclazide modified release-based regimen. A multicentre, randomized, parallel-group, 6-month evaluation. Diabetes Obes Metab. 2008; 10: 1239.
13. American Diabetes Association, Self-monitoring of blood glucose (consensus statement). Diabetes Care . 1996; 19: S62– 6.
14. American Diabetes Association Diagnosis and classification of diabetes mellitus. Diabetes Care. 2010; 33: S62– 9.
15. American Diabetes Association: Standards of medical care in diabetes (Position Statement). Diabetes Care . 2004; 27: S15– S35.
16. American Diabetes Association, Standards of medical care in diabetes—2008. Diabetes Care. 2008; 31 Suppl 1: S12- 54.
17. Antiplatelet Trialists’ Collaboration, Collaborative review of randomized trials of antiplatelet therapy, I: prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Br. Med. J. 1994; 308: 81– 106.
18. A. Shahab .Why does diabetes mellitus increase the risk of cardiovascular disease? Acta Med Indones. 2006 Jan- Mar; 38 (1): 33- 41.
19. A. Vinik and M. Flemmer, Diabetes and macrovascular disease. J Diabetes Complicat. 2002; 16 : 235– 45.
20. B. Guerci, P. Drouin and V. Grangé et al. Self-monitoring of blood glucose significantly improves metabolic control in patients with type 2 diabetes mellitus: the Auto-Surveillance Intervention Active (ASIA) study. Diabetes Metab. 2003; 29: 587– 94.
21. B. Lesobre . Cardiovascular risk factors in type 2 diabetes: Diabete Metab. 1994 Nov; 20 (3 Pt 2) :351- 6.
22. B. L. Nyomba, L. Berard and L. J. Murphy. Facilitating access to glucometer reagents increases blood glucose self-monitoring frequency and improves glycemic control: a prospective study in insulin-treated diabetic patients. Diabet Med. 2004; 21: 129– 35.
23. C. A. Reasner . Reducing cardiovascular complications of type 2 diabetes by targeting multiple risk factors. J Cardiovasc Pharmacol. 2008 Aug; 52 (2): 136- 44.
24. C. C. Chen, K. S. Dai, D. Y. Tai and P. Ho et al. Clinical evaluation of the eBsensor hand-held blood glucose monitoring system, Clin Chim Acta . 2007 ; 377 : 170– 3.
25. C. C. Rheney and J. K. Kirk. Performance of three blood glucose meters. Ann Pharmacother. 2000; 34: 317– 21.
26. C. Giannini , A .Mohn, F. Chiarelli. Technology and the issue of cost/benefit in diabetes. Diabetes Metab Res Rev. 2009 Sep; 25 Suppl 1: S34- 44.
27. C. H. Wei, T. C. Peng, P. Y. Wang, J. J. Lin, M. L. Chuang, and C. C. Chen. Clinical evaluation and alternative site blood glucose testing of the EasyPlus mini R2N blood glucose monitoring system. Clin Chim Acta. 2009; 403 (1-2) : 167- 72.
28. C. J. McCabe, R. C. Stevenson, A. M. Dolan. Evaluation of a diabetic foot screening and protection programme, Diabet. Med. 1998; 15: 80– 4.
29. CLSI. Method comparsion and bias estimation using patient samples; aproved guideline-second edition. CLSI document EP9- A2. CLSI1- 56238- 472- 4: 2002.
30. C. P .Price. Point- of- care testing in diabetes mellitus. Clin. Chem. Lab. Med. 2003; 41:1213–9.
31. D. A. Gough . J. D. Andrade . Enzyme electrodes. Science. 1973 Apr 27; 180 (4084) : 380- 4.
32. D. Arabadjief and J.H. Nichols. Assessing glucose meter accuracy. Curr Med Res Opin; 2006; 22: 2167–74.
33. D. B. Sacks, D. E. Bruns, D. E. Goldstein, N. K. Maclaren, J. M. McDonald and M. Parrott. Guidelines and recommendation for laboratory analysis in the diagnosis and management of diabetes mellitus, Clin. Chem. 2002; 48: 436–72.
34. DCCT Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N. Engl. J. Med.1993; 329 : 977– 86.
35. D. D. Cunningham, T. P. Henning and E. B. Shain et al. Vacuum-assisted lancing of the forearm: an effective and less painful approach to blood glucose monitoring. Diabetes Technol Ther. 2000; 2 : 541– 8.
36. D. G. Altman, J. M. Bland. Measurement in medicine: the analysis of method comparison studies. Statistician. 1983; 32: 307– 17.
37. D. Hill , M. Fisher. The effect of intensive glycaemic control on cardiovascular outcomes. Diabetes Obes Metab. 2010 Aug; 12 (8) : 641- 7.
38. D. J. Cox, W. L. Clarke and L. Gonder- Frederick et al. Accuracy of perceiving blood glucose in IDDM. Diabetes Care. 1985; 8: 529– 36.
39. D. K. Littzelman, C. W. Slemenda, C. D. Langefeld, L. M. Hays, M. A. Welch, D. E. Bild, E .S. Ford, F. Vinicor. Reduction of lower extermity clinical abnormalities in patients with non-insulin-dependent diabetes mellitus: a randomized controlled trial. Ann. Intern. Med. 1993; 119 : 36– 41.
40. D. L. Hoyert, M. P. Heron, S. L. Murphy and H. C. Kung. Deaths: final data for 2003. Natl Vital Stat Rep. 2006; 54: 1– 120.
41. Early Treatment Diabetic Retinopathy Study (ETDRS) Research Group. Early photocoagulation for diabetic retinopathy: ETDRS report number 9. Ophthalmology (Suppl.). 1991; 98: 767– 85.
42. E. H. Yoo , S. Y. Lee . Glucose biosensors: an overview of use in clinical practice. Sensors (Basel). 2010; 10 (5) : 4558- 76.
43. E. J. D’Costa, I. J Higgins., A. P. Turner. Quinoprotein glucose dehydrogenase and its application in an amperometric glucose sensor. Biosensors. 1986; 2: 71– 87.
44. Executive summary of the Third Report of the national Cholesterol Education Program (NECP) Expert Panel on Detection, Evaluation, and Treatment of High blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001; 285 (19) : 2486- 97.
45. F. Guido, B. Annette, J. Nina, Z. Eva, K. Serge, T. Jacques, H. Frank, H. Cornelia. System Accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197 Diabetes Technology & Theraeutics. 2010; 12( 3) :221-31.
46. Food and Drug Adminstration. Total product life cycle for portable invasive blood glucose monitoring systems (draft guidance for industry and FDA staff). Rockville, M D: Center for Devices and Radiological Health, Food and Drug Adminstration, US Department of Health and Human Services: 2006.
47. Food and Drug Administration ( FDA ), Advice for Patients: Serious Errors with Certain Blood Glucose Monitoring Test Strips. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/ucm177189.htm, 2009.
48. Food and Drug Administration ( FDA ), FDA Public Health Notification: Potentially Fatal Errors with GDH-PQQ* Glucose Monitoring Technology. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm176992.htm, 2009.
49. G. A. Brunner, M. Ellmerer and G. Sendlhofer et al. Validation of home blood glucose meters with respect to clinical and analytical approaches. Diabetes Care. 1998; 21: 585– 90.
50. G. G. Guilbault, G. J. Lubrano. An enzyme electrode for the amperometric determination of glucose. Anal. Chim. Acta. 1973; 64: 439– 55.
51. G. H. Murata, J. H. Shah and R. M. Hoffman et al., Intensified blood glucose monitoring improves glycemic control in stable, insulin-treated veterans with type 2 diabetes: the Diabetes Outcomes in Veterans Study (DOVES). Diabetes Care. 2003; 26: 1759– 63.
52. G. Roglic, N. Unwin and P. H. Bennett et al., The burden of mortality attributable to diabetes: realistic estimates for the year 2000. Diabetes Care. 2005; 28: 2130– 5.
53. G. S. Bimenya, G. R. Nzarubara, J. Kiconco, S. Sabuni and W. Byarugaba. The accuracy of self monitoring blood glucose meter systems in Kampala Uganda, Afr Health Sci. 2003; 3: 23– 32.
54. G. Viberti . The need for tighter control of cardiovascular risk factors in diabetic patients. J Hypertens Suppl. 2003 Mar; 21 (1) : S3- 6.
55. H. King, R. E. Aubert, W. H. Herman. Global burden of diabetes, 1995–2025: prevalence, numerical estimates, and projections. Diabetes Care 1998; 21 : 1414– 31.
56. H. U. Janka . Epidemiology and risk factors of macrovascular disease in diabetes mellitus. : Horm Metab Res Suppl. 1990; 22 : 8- 11.
57. H. W. Rodbard, L. Blonde, S. S. Braithwaite, E. M. Brett, R. H. Cobin, Y. Handelsman, R. Hellman, P. S. Jellinger, L. G. Jovanovic, P. Levy, J.I. Mechanick, and F. Zangeneh. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Endocr Pract. 2007; 13 Suppl 1: 1- 68.
58. I. Berlin, J. C. Bisserbe and R. Eiber et al. Phobic symptoms, particularly the fear of blood and injury, are associated with poor glycemic control in type I diabetic adults. Diabetes Care. 1997; 20: 176– 8.
59. International Diabetes Federation Task Force on Diabetes Health Economics, Diabetes health economics: facts, figures, and forecasts, International Diabetes Federation, Brussels, 1997.
60. I. Perkins. Diabetes mellitus epidemiology-classification, determinants, and public health impacts. J Miss State Med Assoc. 2004; 45 : 355– 62.
61. ISO/CD 15197: Determination of Performance Criteria for In Vitro Blood Glucose Monitoring Systems for Management of Human Diabetes Mellitus, ISO Central Secretariat, Geneva (2001).
62. I. Tkác . Pathogenic aspects of diabetic macroangiopathy. Vnitr Lek. 1990 Jun; 36 (6) : 590- 6.
63. J. A. Beckman , M. A. Creager , P. Libby . Diabetes and atherosclerosis: epidemiology, pathophysiology, and management, JAMA. 2002 May 15; 287 (19) : 2570- 81. Comment in: . JAMA. 2002 Aug 28; 288 (8) : 955.
64. J. Berlin, C. Bisserbe and R. Eiber et al. Phobic symptoms, particularly the fear of blood and injury, are associated with poor glycemic control in type I diabetic adults. Diabetes Care. 1997; 20: 176– 8.
65. J. B. Saddinne, K. M. V. Narayan, M. M. Engelgau, R. E. Aubert, R. Klein, G. L. A. Beckles. Prevalence of self-rated visual impairment among adults with diabetes — United States, 1995, Am. J. Pub. Health. 1999; 89: 1200– 5.
66. J. C. Pickup , G. W. Shaw , D. J. Claremont . Potentially-implantable, amperometric glucose sensors with mediated electron transfer: improving the operating stability, Biosensors. 1989; 4 (2) : 109- 19.
67. J. E Shaw., R. A. Sicree, P. Z. Zimmet. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res. Clin. Pract. 2010; 87: 4– 14.
68. J. H. Nichols, What is accuracy and how close must the agreement be? Diabetes Technol Ther. 2005; 7 : 558– 62.
69. J. Julien . Cardiac complications in non-insulin-dependent diabetes mellitus. J Diabetes Complications. 1997 Mar-Apr; 11 (2) : 123- 30.
70. J. K. Kirk , J. Stegner . Self-monitoring of blood glucose: practical aspects. J Diabetes Sci Technol. 2010 Mar 1; 4(2): 435- 9.
71. J. L. Parkes, S. L. Slatin, S. Pardo, B. H. Ginsberg. A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose. Diabetes Care. 2000; 23 (8) : 1143- 8.
72. J . Ono . Standardization and recommendations for the appropriate use of automated devices for self-monitoring blood glucose. Rinsho Byori. 2001 Dec; 49 (12) : 1190- 8.
73. J. Stamler, O. Vaccaro, J. D. Neaton, D. Wentworth. Diabetes, other risk factors, and 12-yr cardiovascular mortality for men screened in the Multiple Risk Factor Intervention Trial. Diabetes Care. 1993; 16: 434.
74. J. Y. Poirier, N. Le Prieur, L. Campion, I. Guilhem, H. Allannic and D. Maugendre, Clinical and statistical evaluation of self-monitoring blood glucose meters. Diabetes Care. 1998; 21: 1919– 24.
75. K. Lewandrowski, R. Cheek, D. M. Nathan, et al. Implementation of capillary blood glucose monitoring in a teaching hospital and determination of program requirements to maintain quality testing. Am J Med. 1992; 93: 419.
76. K. L. Nichol, J. Wuorenma, T. von Sternberg. Benefits of influenza vaccination for low-,intermediate-, and high risk senior citizens. Arch. Intern. Med. 1998; 158:1769– 76.
77. K. M. Narayan, E. W. Gregg, A. Fagot-Campagna, M. M. Engelgau and F. Vinicor. Diabetes—a common, growing, serious, costly, and potentially preventable public health problem, Diabetes Res Clin Pract. 2000; 50 : S77– 84.
78. K. S. Dai, D. Y. Tai and P. Ho et al. Accuracy of the EasyTouch blood glucose self-monitoring system: a study of 516 cases. Clin Chim Acta .2004; 349 : 135– 41.
79. K. Tonyushkina . Glucose meters: a review of technical challenges to obtaining accurate results. J Diabetes Sci Technol. 2009 Jul 1; 3 (4) : 971- 80.
80. L. B. Jr. Wingard , C. C. Liu, S. K. Jr. Wolfson , S.J. Yao . Potentiometric measurement of glucose concentration with an immobilized glucose oxidase/catalase electrode. Diabetes Care. 1982 May-Jun ; 5(3): 199- 202.
81. L. B. Jr. Wingard , J. G. Schiller, S. K. Jr. Wolfson , C. C. Liu, A. L. Drash , S. J. Yao . Immobilized enzyme electrodes for the potentiometric measurement of glucose concentration: immobilization techniques and materials. J Biomed Mater Res. 1979 Nov; 13 (6) : 921- 35.
82. L. C. Clark., C. Jr., Lyons. Electrode systems for continuous monitoring in cardiovascular surgery. Ann. N. Y. Acad. Sci. 1962; 102: 29– 45.
83. L. Gorton, E. Dominguez. Electrocatalytic oxidation of NAD(P) H at mediator-modified electrodes. J. Biotechnol. 2002; 82: 371– 92.
84. L. X. Tang, P. Vadgama . Optimisation of enzyme electrodes. Med Biol Eng Comput. 1990 May; 28 (3) : B18- 24.
85. M. Cohen, E. Boyle, C. Delaney and J. Shaw. A comparison of blood glucose meters in Australia. Diabetes Res Clin Pract. 2006; 71 (2) : 113– 8.
86. M. E. Lyon, and A. W. Lyon. Analysis of the performance of the CONTOUR(R) TS Blood Glucose Monitoring System: when regulatory performance criteria are met, should we have confidence to use a medical device with all patients? J Diabetes Sci Technol. 5 (1): 206-8.
87. M. Evans , A. Roberts , S. Davies , A. Rees . Medical lipid-regulating therapy: current evidence, ongoing trials and future developments. Drugs. 2004; 64 (11): 1181- 96.
88. M. Franciosi, F. Pellegrini and G. De Berardis et al. The impact of blood glucose self-monitoring on metabolic control and quality of life in type 2 diabetic patients: an urgent need for better educational strategies. Diabetes Care .2001; 24 : 1870– 7.
89. M. I. Harris, R. Klein, T. A. Welborn, M. W. K.nuiman. Onset of NIDDM occurs at least 4-7 yr before clinical diagnosis. Diabetes Care. 1992; 15: 815.
90 M. I. Harris. Summary, in: National Diabetes Data Group. Diabetes in America (NIH publication no. 95- 1468), 2nd edn., Government Printing Office, Washington, DC, 1995, pp. 1–14.
91. M. I. Uusitupa, L. K. Niskanen, O .Siitonen, et al. Ten-year cardiovascular mortality in relation to risk factors and abnormalities in lipoprotein composition in type 2 (non-insulin-dependent) diabetic and non-diabetic subjects. Diabetologia. 1993; 36: 1175.
92. M. Khamaisi , I. D. Wexler , J. Skrha , K. Strojek , I. Raz, Z. Milicevic .Cardiovascular disease in type 2 diabetics: epidemiology, risk factors and therapeutic modalities. Isr Med Assoc J. 2003 Nov; 5 (11) : 801- 6.
93. M. K. Weibel, H. J. Bright. The glucose oxidase mechanism. Interpretation of the pH dependence. J. Biol. Chem. 1971; 246: 2734– 44.
94. M. Laakso. Hyperglycemia and cardiovascular disease in type 2 diabetes. Diabetes. 1999 May; 48 (5): 937- 42.
95. M. Larbig, T. Forst, A. Mondok, S. Forst and A. Pfützner. Investigation on the accuracy of the blood glucose monitoring device Prestige IQ. Diabetes Nutr Metab. 2003; 16: 257– 61.
96. M. Leutenegger , E. Bertin . Diabetes mellitus and atherosclerosis. Physiopathology of diabetic macroangiopathy : Rev Med Interne. 1995; 16(1): 31- 42.
97. M. L. Kashyap . Cholesterol and atherosclerosis: a contemporary perspective.: Ann Acad Med Singapore. 1997 Jul; 26 (4): 517- 23.
98. M. Massi-Benedetti , M.O. Federici . Cardiovascular risk factors in type 2 diabetes: the role of hyperglycaemia. Exp Clin Endocrinol Diabetes. 1999; 107 Suppl 4: S120- 3.
99. M. Montagnana, M. Caputo , D. Giavarina , G. Lippi . Overview on self-monitoring of blood glucose. Clin Chim Acta. 2009 Apr; 402 (1-2): 7- 13.
100. M. P. Stern . The effect of glycemic control on the incidence of macrovascular complications of type 2 diabetes.: Arch Fam Med. 1998 Mar-Apr; 7 (2) : 155- 62.
101. M. R. Lopes , J. Morais , C. Andrade. Diabetes mellitus and coronopathy : Rev Port Cardiol. 1989 Nov; 8 (11): 795 -9.
102. M. Sclavo . Cardiovascular risk factors and prevention in women: similarities and differences: Ital Heart J Suppl. 2001 Feb; 2 (2): 125- 41.
103. M. Zayats, E. Katz, R. Baron, I. Willner. Reconstitution of apo-glucose dehydrogenase on pyrroloquinoline quinone-functionalized au nanoparticles yields an electrically contacted biocatalyst. J. Am. Chem. Soc. 2005; 127: 12400– 6.
104. N. Mori, Y. Oono and Y. Murase et al. Evaluation of SMBG values using various instruments and clinical significance of forearm SMBG measurement. Rinsho Byori.2004; 52: 883– 90.
105. O. A. Raitman, F. Patolsky, E. Katz. Electrical contacting of glucose dehydrogenase by the reconstitution of a pyrroloquinoline quinone-functionalized polyaniline film associated with an Au-electrode: an in situ electrochemical SPR study. Chem. Commun. (Camb.) 2002: 1936– 7.
106. O. H. Franco, E. W. Steyerberg, F. B. Hu, et al. Associations of diabetes mellitus with total life expectancy and life expectancy with and without cardiovascular disease. Arch Intern Med 2007; 167: 1145.
107. P. F. Tate, C. A. Clements and J. E. Walters. Accuracy of home blood glucose monitors, Diabetes Care. 1992; 15 : 536– 8.
108. P. H. Sonksen, S. L. Judd and C. Lowy. Home monitoring of blood-glucose. Method for improving diabetic control. Lancet. 1978; 1 : 729– 32.
109. P. N. Bartlett, E. Simon. Modified electrodes for NADH oxidation and dehydrogenase-based biosensors. Bioelectrochemistry. 2002; 56: 117– 22.
110. P. N. Bartlett, R. G. Whitaker. Strategies for the development of amperometric enzyme electrodes. Biosensors. 1987; 3: 359– 79.
111. P. Vadgama . Enzyme electrodes as practical biosensors. J Med Eng Technol. 1981 Nov; 5 (6): 293-8.
112. R. A. Kreisberg . Diabetic dyslipidemia. Am J Cardiol. 1998 Dec 17; 82(12A): 67U- 73U; discussion 85U- 86U.
113. R. Boussageon , T. Bejan-Angoulvant , M. Saadatian-Elahi , S. Lafont, C. Bergeonneau , B. Kassaï , S. Erpeldinger, J. M. Wright , F. Gueyffier , C. Cornu . Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: meta-analysis of randomised controlled trials. BMJ. 2011 Jul 26; 343: d4169. doi: 10.1136/bmj.d4169.
114. R. D. Toto. Heart disease in diabetic patients.: Semin Nephrol. 2005 Nov; 25 (6): 372- 8.
115. R. J. McEnroe, M. F. Burritt, D. M. Powers, D. W. Rheinheimer, and B. H. Wallace. Interference Tsting in Clinical Chemistry. Approved Guideline, Second Edition 2005. 2005; 25 (27): 43- 78.
116. R. Weitgasser, B. Gappmayer and M. Pichler, Newer portable glucose meters analytical improvement compared with previous generation device? Clin Chem. 1999; 45: 1821– 5.
117. S. A. Boren and W. L. Clarke. Analytical and clinical performance of blood glucose monitors. J Diabetes Sci Technol. 2010; 4 (1): 84- 97
118. S. Alva , S. Sen Gupta , R. S. Phadke , G .Govil .Glucose oxidase immobilized electrode for potentiometric estimation of glucose. Biosens Bioelectron. 1991; 6 (8): 663- 8.
119. S. Anthony, T. Odgers and W. Kelly, Health promotion and health education about diabetes mellitus. J R Soc Health. 2004; 124: 70– 3.
120. S. B Bankar., M. V. Bule, R. S. Singhal, L. Ananthanarayan. Glucose oxidase--an overview. Biotechnol. Adv. 2009; 27: 489– 501.
121. S. Coccheri. Approaches to prevention of cardiovascular complications and events in diabetes mellitus. Drugs. 2007; 67: 997– 1026.
122. S. Dagogo-Jack. Preventing diabetes-related morbidity and mortality in the primary care setting. J Natl Med Assoc. 2002; 94: 549– 60.
123. S. E. Fineberg, R. M. Bergenstal, R. M. Bernstein, L. M. Laffel and S. L. Schwartz. Use of an automated device for alternative site blood glucose monitoring. Diabetes Care .2001; 24 : 1217– 20.
124. S. H. Meeuwisse-Pasterkamp , M. M. van der Klauw , B. H. Wolffenbuttel . Type 2 diabetes mellitus: prevention of macrovascular complications. Expert Rev Cardiovasc Ther. 2008 Mar; 6 (3): 323- 1.
125. S. I. Yum, J . Roe . Capillary blood sampling for self-monitoring of blood glucose. Diabetes Technol Ther. 1999 Spring; 1(1): 29-37.
126. S. J. Updike. G. P. Hicks. The enzyme electrode. Nature. 1967; 214: 986– 988
127. S. M. Grundy, J. I. Cleeman, N. B. Merz, et al. Implication of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Ciculation. 2004; 110: 227- 39.
128. S. M. Haffner . Management of dyslipidemia in adults with diabetes .Diabetes Care. 1998 Jan; 21 (1): 160- 78.
129. Standardization. I. O. f. In vitro diagnostic test systems-Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO International Standard 15197: 2003.
130. S. V. Edelman . Importance of glucose control. Med Clin North Am. 1998 Jul; 82 (4): 665- 87.
131. S. Walford, E. A. Gale, S. P. Allisson and R. B. Tattersall. Self-monitoring of blood-glucose. Improvement of diabetic control. Lancet.1978; 1 : 732– 5.
132. S. Wild, G. Roglic, A. Green, R. Sicree and H. King. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004; 27 : 1047– 53.
133. The UK Prospective Diabetes Study (UKPDS) Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes (UKPDS 38). Br. Med. J. 1998; 317: 703– 13.
134. W. A. Alto, D. Meyer, J. Schneid, P. Bryson and J. Kindig. Assuring the accuracy of home glucose monitoring. J Am Board Fam Pract. 2002; 15: 1– 6.
135. W. Jin, U. Wollenberger, Scheller F. W. PQQ as redox shuttle for quinoprotein glucose dehydrogenase. Biol. Chem. 1998; 379: 1207– 11.
136. W. L. Clarke, D. Cox, L. A. Gonder-Frederick, W. Carter and S. L. Pohl. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care (5). 1987; 10 : 622– 8.
137. Y. Ikeda and A. Tsuruoka. Self-monitoring of blood glucose, as a means of self-management, Diabetes Res Clin Pract . 1994; pp. S269–S271 [Suppl].
138. Z. Trajanoski, G. A. Brunner, R. J. Gfrerer, P. Wach and T. R. Pieber. Accuracy of home blood glucose meters during hypoglycemia. Diabetes Care. 1996; 19: 1412– 5.