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1 NOKLUS, Norwegian Center for Quality Improvement of Primary Care Laboratories, Division of General Practice, Department of Public Health and Primary Care, Ulriksdal 8c, University of Bergen, N-5009 Bergen, Norway.
aAddress correspondence to this author at: Department of Medicine, Rogaland Central Hospital, PO Box 8100, 4068 Stavanger, Norway. Fax 47-51-51-99-06; e-mail svskeie{at}online.no.
Background: Instruments for self-monitoring of blood glucose (SMBG) are increasingly used by patients with diabetes. The analytical quality of meters in routine use is poorly characterized.
Methods: We compared SMBG performance achieved by patients and by a medical laboratory technician. Imprecision was calculated from duplicate measurements, and deviation as the difference between the first measurement and the mean of duplicate laboratory-method results (calibrated with NIST material). Analytical quality for five groups of SMBG instruments was compared with quality specifications for BG measurements. All participants completed a questionnaire assessing both SMBG training and use of the meters.
Results: We recruited 159 SMBG users from a hospital outpatient clinic and 263 others from 65 randomly selected general practices (total of 422). Most (two thirds) used insulin. CVs for the five meter types were 7%, 11%, 18%, 18%, and 20% in the hands of patients and 2.5–5.9% for the technician. For three of five meter types, patients’ BG measurements had larger deviations from the laboratory results than did the technician’s results. The technician’s performance could not predict the patients’. No instrument when used by patients (but two operated by the technician) met published quality specifications. The analytical quality of patients’ results was not related to whether they had chosen the instruments on advice from healthcare personnel (one-third of patients), were only self-educated in SMBG (50%), or performed SMBG fewer than seven times/week (62%).
Conclusions: The analytical quality of SMBG among patients was poorer than, and could not be predicted from, the performance of the meters in the hands of a technician. We suggest that new instruments be tested in the hands of patients who are trained on meter use in a routine way.
The following articles in journals at HighWire Press have cited this article:
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  R. J. Schrot, K. T. Patel, and P. Foulis Evaluation of Inaccuracies in the Measurement of Glycemia in the Laboratory, by Glucose Meters, and Through Measurement of Hemoglobin A1c Clin. Diabetes, April 1, 2007; 25(2): 43 - 49. [Abstract] [Full Text] [PDF]
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 G. B.B. Kristensen, K. Nerhus, G. Thue, and S. Sandberg Results and Feasibility of an External Quality Assessment Scheme for Self-Monitoring of Blood Glucose Clin. Chem., July 1, 2006; 52(7): 1311 - 1317. [Abstract] [Full Text] [PDF]
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G. B.B. Kristensen, N. G. Christensen, G. Thue, and S. Sandberg Between-Lot Variation in External Quality Assessment of Glucose: Clinical Importance and Effect on Participant Performance Evaluation Clin. Chem., September 1, 2005; 51(9): 1632 - 1636. [Abstract] [Full Text] [PDF]
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S. Skeie, C. Perich, C. Ricos, A. Araczki, A. R. Horvath, W. P. Oosterhuis, T. Bubner, G. Nordin, R. Delport, G. Thue, et al. Postanalytical External Quality Assessment of Blood Glucose and Hemoglobin A1c: An International Survey Clin. Chem., July 1, 2005; 51(7): 1145 - 1153. [Abstract] [Full Text] [PDF]
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H. W. Vesper, E. Archibold, K. H. Porter, and G. L. Myers Assessment of a Reference Procedure to Collect and Analyze Glucose in Capillary Whole Blood Clin. Chem., May 1, 2005; 51(5): 901 - 903. [Full Text] [PDF]
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W. E. Winter A Rosetta Stone for Insulin Treatment: Self-Monitoring of Blood Glucose Clin. Chem., June 1, 2004; 50(6): 985 - 987. [Full Text] [PDF]
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G. B.B. Kristensen, K. Nerhus, G. Thue, and S. Sandberg Standardized Evaluation of Instruments for Self-Monitoring of Blood Glucose by Patients and a Technologist Clin. Chem., June 1, 2004; 50(6): 1068 - 1071. [Full Text] [PDF]
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 D. C. Klonoff The Need for Separate Performance Goals for Glucose Sensors in the Hypoglycemic, Normoglycemic, and Hyperglycemic Ranges Diabetes Care, March 1, 2004; 27(3): 834 - 836. [Full Text] [PDF]
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 A. L. Briggs and S. Cornell Self-monitoring Blood Glucose (SMBG): Now and the Future Journal of Pharmacy Practice, February 1, 2004; 17(1): 29 - 38. [Abstract] [PDF]
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J. S. Krouwer Proposal to Add an Optional Recommendations Section to Clinical Chemistry Abstracts Clin. Chem., December 1, 2002; 48(12): 2292 - 2292. [Full Text] [PDF]
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M. Nattrass Improving Results from Home Blood-Glucose Monitoring: Accuracy and Reliability Require Greater Patient Education as Well as Improved Technology Clin. Chem., July 1, 2002; 48(7): 979 - 980. [Full Text] [PDF]
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