메뉴 건너뛰기




Volumn 7, Issue 6, 2013, Pages 1585-1594

Assessing the analytical performance of systems for self-monitoring of blood glucose: Concepts of performance evaluation and definition of metrological key terms

Author keywords

Accuracy; Blood glucose meter evaluation; Diabetes; Self monitoring of blood glucose; Trueness

Indexed keywords

GLUCOSE;

EID: 84900540435     PISSN: None     EISSN: 19322968     Source Type: Journal    
DOI: 10.1177/193229681300700619     Document Type: Review
Times cited : (17)

References (40)
  • 1
    • 0029082033 scopus 로고
    • Veterans Afairs Cooperative Study on glycemic control and complications in type II diabetes (VA CSDM). Results of the feasibility trial. Veterans Afairs Cooperative Study in Type II Diabetes
    • Abraira C, Colwell JA, Nuttall FQ, Sawin CT, Nagel NJ, Comstock JP, Emanuele NV, Levin SR, Henderson W, Lee HS. Veterans Afairs Cooperative Study on glycemic control and complications in type II diabetes (VA CSDM). Results of the feasibility trial. Veterans Afairs Cooperative Study in Type II Diabetes. Diabetes Care. 1995;18(8):1113-23.
    • (1995) Diabetes Care , vol.18 , Issue.8 , pp. 1113-1123
    • Abraira, C.1    Colwell, J.A.2    Nuttall, F.Q.3    Sawin, C.T.4    Nagel, N.J.5    Comstock, J.P.6    Emanuele, N.V.7    Levin, S.R.8    Henderson, W.9    Lee, H.S.10
  • 2
    • 77955816974 scopus 로고    scopus 로고
    • Benefits of self-monitoring blood glucose in the management of new-onset type 2 diabetes mellitus: The St Carlos Study, a prospective randomized clinic-based interventional study with parallel groups
    • Durán A, Martín P, Runkle I, Pérez N, Abad R, Fernández M, Del Valle L, Sanz MF, Calle-Pascual AL. Benefits of self-monitoring blood glucose in the management of new-onset type 2 diabetes mellitus: the St Carlos Study, a prospective randomized clinic-based interventional study with parallel groups. J Diabetes. 2010;2(3):203-11.
    • (2010) J Diabetes , vol.2 , Issue.3 , pp. 203-211
    • Durán, A.1    Martín, P.2    Runkle, I.3    Pérez, N.4    Abad, R.5    Fernández, M.6    Del Valle, L.7    Sanz, M.F.8    Calle-Pascual, A.L.9
  • 3
    • 84860533866 scopus 로고    scopus 로고
    • The impact of structured blood glucose testing on attitudes toward self-management among poorly controlled, insulin-naive patients with type 2 diabetes
    • Fisher L, Polonsky WH, Parkin CG, Jelsovsky Z, Petersen B, Wagner RS. The impact of structured blood glucose testing on attitudes toward self-management among poorly controlled, insulin-naive patients with type 2 diabetes. Diabetes Res Clin Pract. 2012;96(2):149-55.
    • (2012) Diabetes Res Clin Pract , vol.96 , Issue.2 , pp. 149-155
    • Fisher, L.1    Polonsky, W.H.2    Parkin, C.G.3    Jelsovsky, Z.4    Petersen, B.5    Wagner, R.S.6
  • 4
    • 79958816342 scopus 로고    scopus 로고
    • ROSES: Role of self-monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial
    • ROSES Study Group
    • Franciosi M, Lucisano G, Pellegrini F, Cantarello A, Consoli A, Cucco L, Ghidelli R, Sartore G, Sciangula L, Nicolucci A; ROSES Study Group. ROSES: role of self-monitoring of blood glucose and intensive education in patients with Type 2 diabetes not receiving insulin. A pilot randomized clinical trial. Diabet Med. 2011;28(7):789-96.
    • (2011) Diabet Med , vol.28 , Issue.7 , pp. 789-796
    • Franciosi, M.1    Lucisano, G.2    Pellegrini, F.3    Cantarello, A.4    Consoli, A.5    Cucco, L.6    Ghidelli, R.7    Sartore, G.8    Sciangula, L.9    Nicolucci, A.10
  • 6
    • 84855419162 scopus 로고    scopus 로고
    • ROSSO-in-Praxi follow-up: Long-term effects of self-monitoring of blood glucose on weight, hemoglobin A1c, and quality of life in patients with type 2 diabetes mellitus
    • Kempf K, Kruse J, Martin S. ROSSO-in-Praxi follow-up: long-term effects of self-monitoring of blood glucose on weight, hemoglobin A1c, and quality of life in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2012;14(1):59-64.
    • (2012) Diabetes Technol Ther , vol.14 , Issue.1 , pp. 59-64
    • Kempf, K.1    Kruse, J.2    Martin, S.3
  • 8
    • 79951717523 scopus 로고    scopus 로고
    • Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: Results from the Structured Testing Program study
    • Polonsky WH, Fisher L, Schikman CH, Hinnen DA, Parkin CG, Jelsovsky Z, Petersen B, Schweitzer M, Wagner RS. Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care. 2011;34(2):262-7.
    • (2011) Diabetes Care , vol.34 , Issue.2 , pp. 262-267
    • Polonsky, W.H.1    Fisher, L.2    Schikman, C.H.3    Hinnen, D.A.4    Parkin, C.G.5    Jelsovsky, Z.6    Petersen, B.7    Schweitzer, M.8    Wagner, R.S.9
  • 12
    • 1442277653 scopus 로고    scopus 로고
    • Blood glucose self-monitoring in non-insulin-treated type 2 diabetes: A qualitative study of patients' perspectives
    • Peel E, Parry O, Douglas M, Lawton J. Blood glucose self-monitoring in non-insulin-treated type 2 diabetes: a qualitative study of patients' perspectives. Br J Gen Pract. 2004;54(500):183-8.
    • (2004) Br J Gen Pract , vol.54 , Issue.500 , pp. 183-188
    • Peel, E.1    Parry, O.2    Douglas, M.3    Lawton, J.4
  • 13
    • 0032511583 scopus 로고    scopus 로고
    • 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
    • UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352(9131):837-53.
    • (1998) Lancet , vol.352 , Issue.9131 , pp. 837-853
  • 15
    • 33846071437 scopus 로고    scopus 로고
    • Understanding the meaning of accuracy, trueness and precision
    • Menditto A, Patriarca M, Magnusson B. Understanding the meaning of accuracy, trueness and precision. Accred Qual Assur. 2007;12:45-7.
    • (2007) Accred Qual Assur , vol.12 , pp. 45-47
    • Menditto, A.1    Patriarca, M.2    Magnusson, B.3
  • 17
    • 0036271429 scopus 로고    scopus 로고
    • Setting performance goals and evaluating total analytical error for diagnostic assays
    • Krouwer JS. Setting performance goals and evaluating total analytical error for diagnostic assays. Clin Chem. 2002;48(6 Pt 1):919-27.
    • (2002) Clin Chem , vol.48 , Issue.6 PART 1 , pp. 919-927
    • Krouwer, J.S.1
  • 18
    • 0029433293 scopus 로고
    • Reference materials and reference measurement systems in laboratory medicine. Harmonization of nomenclature and definitions in reference measurement systems
    • Dybkaer R. Reference materials and reference measurement systems in laboratory medicine. Harmonization of nomenclature and definitions in reference measurement systems. Eur J Clin Chem Clin Biochem. 1995;33(12):995-8.
    • (1995) Eur J Clin Chem Clin Biochem , vol.33 , Issue.12 , pp. 995-998
    • Dybkaer, R.1
  • 19
    • 70350175257 scopus 로고    scopus 로고
    • Glucose meters: A review of technical challenges to obtaining accurate results
    • Tonyushkina K, Nichols JH. Glucose meters: a review of technical challenges to obtaining accurate results. J Diabetes Sci Technol. 2009;3(4):971-80.
    • (2009) J Diabetes Sci Technol , vol.3 , Issue.4 , pp. 971-980
    • Tonyushkina, K.1    Nichols, J.H.2
  • 21
    • 84900543218 scopus 로고    scopus 로고
    • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Annex I A 3
    • 07/12
    • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Annex I A 3. Official Journal L 331, 07/12/1998.
    • (1998) Official Journal , vol.L 331
  • 22
    • 67650890638 scopus 로고    scopus 로고
    • Working Group 1 of the Joint Committee for Guides in Metrology. Accessed July 1, 2013
    • Working Group 1 of the Joint Committee for Guides in Metrology. Evaluation of measurement data - guide to the expression of uncertainty in measurement. 2008. http://www.bipm.org/utils/common/documents/jcgm/JCGM-100- 2008-E.pdf. Accessed July 1, 2013.
    • (2008) Evaluation of Measurement Data - Guide to the Expression of Uncertainty in Measurement
  • 25
    • 66549112943 scopus 로고    scopus 로고
    • Traceability in laboratory medicine
    • Vesper HW, Thienpont LM. Traceability in laboratory medicine. Clin Chem. 2009;55(6):1067-75.
    • (2009) Clin Chem , vol.55 , Issue.6 , pp. 1067-1075
    • Vesper, H.W.1    Thienpont, L.M.2
  • 26
    • 79952198354 scopus 로고    scopus 로고
    • Glucose information for tight glycemic control: Different methods with different challenges
    • Weber C, Neeser K. Glucose information for tight glycemic control: different methods with different challenges. J Diabetes Sci Technol. 2010;4(5):1269-75.
    • (2010) J Diabetes Sci Technol , vol.4 , Issue.5 , pp. 1269-1275
    • Weber, C.1    Neeser, K.2
  • 27
    • 0023622528 scopus 로고
    • Precision of glucose measurements in control sera by isotope dilution/mass spectrometry: Proposed definitive method compared with a reference method
    • Pelletier O, Arratoon C. Precision of glucose measurements in control sera by isotope dilution/mass spectrometry: proposed definitive method compared with a reference method. Clin Chem. 1987;33(8):1397-402.
    • (1987) Clin Chem , vol.33 , Issue.8 , pp. 1397-1402
    • Pelletier, O.1    Arratoon, C.2
  • 28
    • 77956932761 scopus 로고    scopus 로고
    • Electrochemical non-enzymatic glucose sensors: A perspective and an evaluation
    • Toghill KE, Compton RG. Electrochemical non-enzymatic glucose sensors: a perspective and an evaluation. Int J Electrochem Sci. 2010;5(9):1246-301.
    • (2010) Int J Electrochem Sci , vol.5 , Issue.9 , pp. 1246-1301
    • Toghill, K.E.1    Compton, R.G.2
  • 29
    • 77954685027 scopus 로고    scopus 로고
    • Analytical and clinical performance of blood glucose monitors
    • Boren SA, Clarke WL. Analytical and clinical performance of blood glucose monitors. J Diabetes Sci Technol. 2010;4(1):84-97.
    • (2010) J Diabetes Sci Technol , vol.4 , Issue.1 , pp. 84-97
    • Boren, S.A.1    Clarke, W.L.2
  • 30
    • 0023205574 scopus 로고
    • Evaluating clinical accuracy of systems for self-monitoring of blood glucose
    • Clarke WL, Cox D, Gonder-Frederick LA, Carter W, Pohl SL. Evaluating clinical accuracy of systems for self-monitoring of blood glucose. Diabetes Care. 1987;10(5):622-8.
    • (1987) Diabetes Care , vol.10 , Issue.5 , pp. 622-628
    • Clarke, W.L.1    Cox, D.2    Gonder-Frederick, L.A.3    Carter, W.4    Pohl, S.L.5
  • 33
    • 0033855803 scopus 로고    scopus 로고
    • A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood glucose
    • Parkes JL, Slatin SL, Pardo S, Ginsberg BH. 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.
    • (2000) Diabetes Care , vol.23 , Issue.8 , pp. 1143-1148
    • Parkes, J.L.1    Slatin, S.L.2    Pardo, S.3    Ginsberg, B.H.4
  • 34
    • 70349240850 scopus 로고    scopus 로고
    • Statistical tools to analyze continuous glucose monitor data
    • Clarke W, Kovatchev B. Statistical tools to analyze continuous glucose monitor data. Diabetes Technol Ther. 2009;11 Suppl 1:S45-54.
    • (2009) Diabetes Technol Ther , vol.11 , Issue.SUPPL. 1
    • Clarke, W.1    Kovatchev, B.2
  • 35
    • 77951733801 scopus 로고    scopus 로고
    • A review of standards and statistics used to describe blood glucose monitor performance
    • Krouwer JS, Cembrowski GS. A review of standards and statistics used to describe blood glucose monitor performance. J Diabetes Sci Technol. 2010;4(1):75-83.
    • (2010) J Diabetes Sci Technol , vol.4 , Issue.1 , pp. 75-83
    • Krouwer, J.S.1    Cembrowski, G.S.2
  • 36
    • 84855185039 scopus 로고    scopus 로고
    • Standards of medical care in diabetes - 2012
    • American Diabetes Association
    • American Diabetes Association. Standards of medical care in diabetes - 2012. Diabetes Care. 2012;35 Suppl 1:S11-63.
    • (2012) Diabetes Care , vol.35 , Issue.SUPPL. 1
  • 37
    • 84865146825 scopus 로고    scopus 로고
    • Accuracy in blood glucose measurement: What will a tightening of requirements yield?
    • Heinemann L, Lodwig V, Freckmann G. Accuracy in blood glucose measurement: what will a tightening of requirements yield? J Diabetes Sci Technol. 2012;6(2):435-43.
    • (2012) J Diabetes Sci Technol , vol.6 , Issue.2 , pp. 435-443
    • Heinemann, L.1    Lodwig, V.2    Freckmann, G.3
  • 38
    • 0003433891 scopus 로고    scopus 로고
    • Accessed September 13, 2013
    • Wikipedia. Reliability engineering. http://en.wikipedia.org/wiki/ Reliability-engineering. Accessed September 13, 2013
    • Reliability Engineering
  • 39
    • 84865134562 scopus 로고    scopus 로고
    • New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting, October 28, 2011
    • Walsh J, Roberts R, Vigersky RA, Schwartz F. New Criteria for Assessing the Accuracy of Blood Glucose Monitors meeting, October 28, 2011. J Diabetes Sci Technol. 2012;6(2):466-74.
    • (2012) J Diabetes Sci Technol , vol.6 , Issue.2 , pp. 466-474
    • Walsh, J.1    Roberts, R.2    Vigersky, R.A.3    Schwartz, F.4
  • 40
    • 24144459072 scopus 로고    scopus 로고
    • Approved IFCC recommendation on reporting results for blood glucose (abbreviated)
    • International Federation of Clinical Chemistry Scientific Division Working Group on Selective Electrodes and Point of Care Testing
    • D'Orazio P, Burnett RW, Fogh-Andersen N, Jacobs E, Kuwa K, Külpmann WR, Larsson L, Lewenstam A, Maas AH, Mager G, Naskalski JW, Okorodudu AO; International Federation of Clinical Chemistry Scientific Division Working Group on Selective Electrodes and Point of Care Testing. Approved IFCC recommendation on reporting results for blood glucose (abbreviated). Clin Chem. 2005;51(9):1573-6.
    • (2005) Clin Chem , vol.51 , Issue.9 , pp. 1573-1576
    • D'Orazio, P.1    Burnett, R.W.2    Fogh-Andersen, N.3    Jacobs, E.4    Kuwa, K.5    Külpmann, W.R.6    Larsson, L.7    Lewenstam, A.8    Maas, A.H.9    Mager, G.10    Naskalski, J.W.11    Okorodudu, A.O.12


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.