HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Submit an electronic Letter to the Editor about this paper Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (22) Citing Articles via Google Scholar Google Scholar Articles by Skeie, S. Articles by Sandberg, S. Search for Related Content PubMed PubMed Citation Articles by Skeie, S. Articles by Sandberg, S. Related Collections Laboratory Management Evidence Based Laboratory Medicine and Test Utilization Endocrinology and Metabolism

Patient-derived Quality Specifications for Instruments Used in Self-Monitoring of Blood Glucose

¹ NOKLUS, Norwegian Center for External Quality Improvement of Primary Care Laboratories, Division of General Practice, Ulriksdal 8c, University of Bergen, N-5009 Bergen, Norway.
^a Address correspondence to this author at: Department of Medicine, Rogaland Central Hospital, PO Box 8100, 4068 Stavanger, Norway. svskeie{at}online.no.

Background: Instruments for self-monitoring of glucose (SMBG) are increasingly used by diabetic patients. Information is limited on how patients use and interpret SMBG results, and no quality specifications for such instruments are based on the opinions of patients.

Methods: Type 1 diabetic patients (n = 201) filled in a questionnaire eliciting daily limits for blood glucose (BG) and changes of BG considered significant at different glucose concentrations. From these responses, patient-derived quality specifications were calculated in different clinical situations with low, intermediate, and high BG concentrations.

Results: Mean age of the patients was 31.8 years, mean diabetes duration was 14.7 years, and mean SMBG duration was 10.0 years with a mean frequency of 11.2 measurements/week. The threshold for hypoglycemic symptoms was 3.0 mmol/L (54 mg/dL), and the mean daily BG target window was 4.3–10.4 mmol/L (77–187 mg/dL). The mean absolute BG changes producing actions from the patients ranged from 1.1 mmol/L (20 mg/dL) to 3.6 mmol/L (65 mg/dL). The analytical quality specifications for imprecision depended on the clinical situation. Excluding the hypoglycemic situation, the analytical CV needed to fulfill the expectations of 75% of the patients was 6.4–9.7%. The analytical quality specification for CV at hypoglycemic concentrations was 3.1%.

Conclusions: Instruments for self-measurements of glucose with an imprecision (CV) of 5% and bias 5% meet the expectations of >75% of patients in clinical situations other than hypoglycemia.

The following articles in journals at HighWire Press have cited this article:

				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]

				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]

				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]

				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]

				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]

				S. Skeie, G. Thue, K. Nerhus, and S. Sandberg Instruments for Self-Monitoring of Blood Glucose: Comparisons of Testing Quality Achieved by Patients and a Technician Clin. Chem., July 1, 2002; 48(7): 994 - 1003. [Abstract] [Full Text] [PDF]

				D. B. Sacks, D. E. Bruns, D. E. Goldstein, N. K. Maclaren, J. M. McDonald, and M. Parrott Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus Clin. Chem., March 1, 2002; 48(3): 436 - 472. [Abstract] [Full Text] [PDF]

				S. Skeie, G. Thue, and S. Sandberg Interpretation of Hemoglobin A1c (HbA1c) Values among Diabetic Patients: Implications for Quality Specifications for HbA1c Clin. Chem., July 1, 2001; 47(7): 1212 - 1217. [Abstract] [Full Text] [PDF]

				G. Geffken and W. E. Winter Hardware and Software in Diabetes Mellitus: Performance Characteristics of Hand-held Glucose Testing Devices and the Application of Glycemic Testing to Patients' Daily Diabetes Management Clin. Chem., January 1, 2001; 47(1): 11 - 12. [Full Text] [PDF]