Testing quality of a self-monitoring blood glucose sensor with an auto-coding mechanism when used by patients versus technicians
Abstract
Background In response to the problem of erroneous readings due to miscoding when performing self-monitoring blood glucose (SMBG), this study introduces a user-friendly SMBG biosensor with an innovative auto-coding module on the meter and strip. Actual users characterized the performance of the SMBG systems. Methods A total of 105 patients were incorporated in the study and Clarke error grid analysis (EGA) was administered to evaluate the clinical accuracy of the results obtained by the patients versus the technicians. All patients used the questionnaires to comment on the use of the auto-coding sensor. Results In the imprecision test, the total CV of the 5 BG levels was 2.1%. In the EGA plot, the results of the auto-coding sensor were 96.2%, both lots A and B, in zone A for the patients and 99.0% and 97.1% for the technician. The paired t-test demonstrated no statistically significant difference between the patient and technician measurements. Regression analysis also demonstrated that the measurements taken by the patients agreed with those obtained using the laboratory method. Conclusions The patients achieved satisfactory performance using the auto-coding SMBG sensor and derived similar results with both laboratory reference and operation by a technician.
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The accuracy reported here for the Contour Next Link 2.4 BGMS is similar to or higher than the other glucose monitoring systems.
“It is difficult to make direct comparisons due to differences in methods among these studies; however, the accuracy reported here for the Contour ® Next Link 2.4 BGMS is similar to or higher than the other glucose monitoring systems.”
From Accuracy and user performance evaluation of the Contour Next Link 2.4 blood glucose monitoring system (2015) · cites this paper as [26]
Cites
Standards of Medical Care in Diabetes—2009
American Diabetes Association (2009) · Diabetes Care · doi:10.2337/dc09-s013 · Cited by 2,167 · see citing works
Evaluating clinical accuracy of systems for self-monitoring of blood glucose
Clarke, W. L., Cox, D., Gonder-Frederick, L. A., Carter, W., & Pohl, S. L. (1987) · Diabetes Care · doi:10.2337/diacare.10.5.622 · Cited by 1,435 · see citing works
Meal-Related Structured Self-Monitoring of Blood Glucose
Schwedes, U., Siebolds, M., Mertes, G., & For the SMBG Study Group (2002) · Diabetes Care · doi:10.2337/diacare.25.11.1928 · Cited by 300 · see citing works
The Original Clarke Error Grid Analysis (EGA)
Clarke, W. L. (2005) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2005.7.776 · Cited by 282 · see citing works
Consensus Statement on Self-Monitor ing of Blood Glucose
(1987) · Diabetes Care · doi:10.2337/diacare.10.1.95 · Cited by 247 · see citing works
Skeie, S., Thue, G., Nerhus, K., & Sandberg, S. (2002) · Clinical Chemistry · doi:10.1093/clinchem/48.7.994 · Cited by 131 · see citing works
Bergenstal, R. M., Pearson, J., Cembrowski, G. S., Bina, D. M., Davidson, J. L., & List, S. (2000) · The Science of Diabetes Self-Management and Care · doi:10.1177/014572170002600610 · Cited by 107 · see citing works
Current evidence regarding the value of self-monitored blood glucose testing
Blonde, L., & Karter, A. J. (2005) · The American Journal of Medicine · doi:10.1016/j.amjmed.2005.07.053 · Cited by 86 · see citing works
Self monitoring of glucose by people with diabetes: evidence based practice: Fig 1
Gallichan, M. (1997) · BMJ · doi:10.1136/bmj.314.7085.964 · Cited by 84 · see citing works
Kristensen, G. B. B., Nerhus, K., Thue, G., & Sandberg, S. (2004) · Clinical Chemistry · doi:10.1373/clinchem.2004.031575 · Cited by 68 · see citing works
Significant Insulin Dose Errors May Occur if Blood Glucose Results are Obtained from Miscoded Meters
Raine, C. H., Schrock, L. E., Edelman, S. V., Mudaliar, S. R. D., Zhong, W., Proud, L. J., & Parkes, J. L. (2007) · Journal of Diabetes Science and Technology · doi:10.1177/193229680700100211 · Cited by 43 · see citing works
Baum, J. M., Monhaut, N. M., Parker, D. R., & Price, C. P. (2006) · Diabetes Technology & Therapeutics · doi:10.1089/dia.2006.8.347 · Cited by 42 · see citing works
Screening for Diabetic Retinopathy
Davies, R., & Brailsford, S. (2005) · International series in management science/operations research/International series in operations research & management science · doi:10.1007/1-4020-8066-2_19 · Cited by 40 · see citing works
Proposed Strategies for Reducing User Error in Capillary Blood Glucose Monitoring
The National Steering Committee for Quality Assurance In Capillary Blood Glucose Monitoring (1993) · Diabetes Care · doi:10.2337/diacare.16.2.493 · Cited by 40 · see citing works
Self-Monitored Blood Glucose: a Common Pitfall
Raine, C. H. (2003) · Endocrine Practice · doi:10.4158/ep.9.2.137 · Cited by 28 · see citing works
Predicted Blood Glucose from Insulin Administration Based on Values from Miscoded Glucose Meters
Raine, C. H., Pardo, S. A., & Parkes, J. L. (2008) · Journal of Diabetes Science and Technology · doi:10.1177/193229680800200404 · Cited by 23 · see citing works
Fabrication of a Glucose Biosensor Based on Inserted Barrel Plating Gold Electrodes
Hsu, C., Chung, H., Tsai, D., Fang, M.-Y., Hsiao, H.-C., & Zen, J. (2008) · Analytical Chemistry · doi:10.1021/ac8019619 · Cited by 16 · see citing works
Self-citationSuperior long-term stability of a glucose biosensor based on inserted barrel plating gold electrodes
Hsu, C., Hsiao, H.-C., Fang, M.-Y., & Zen, J. (2009) · Biosensors and Bioelectronics · doi:10.1016/j.bios.2009.07.028 · Cited by 14 · see citing works
Self-citationNattrass, M. (2002) · Clinical Chemistry · doi:10.1093/clinchem/48.7.979 · Cited by 9 · see citing works
Growing demand yields 'friendlier' blood sugar monitors.
Burney, M. (1998) · PubMed · Cited by 3 · see citing works
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Bailey, T., Wallace, J. F., Greene, C., Pardo, S., Brown, D., Pflug, B., & Klaff, L. J. (2015) · Clinica Chimica Acta · doi:10.1016/j.cca.2015.06.001 · Cited by 14 · see citing works
Electrochemical Glucose Biosensors for Diabetes Care
Ocvirk, G., Buck, H., & DuVall, S. H. (2016) · Bioanalytical reviews · doi:10.1007/11663_2016_3 · Cited by 13 · see citing works
Ma, Y., Burton, C., & Shi, H. (2014) · Clinica Chimica Acta · doi:10.1016/j.cca.2014.08.044 · Cited by 1 · see citing works
- Authors
- Hsu, C.-T., Wu, M.-H., Kuo, C.-Y., & Zen, J.-M.
- Affiliations
- Chung Shan Medical University (TW)
- Min Sheng General Hospital (TW)
- National Chung Hsing University (TW)
- Corresponding author
- Hsu, Cheng-Teng
- Zen, Jyh-Myng
- ORCID
- Wu, Ming-Hsun
- Venue
- Clinica Chimica Acta
- Publisher
- Elsevier BV
- Published
- 2014-11
- Volume
- 437
- Pages
- 62-65
- ISSN
- 0009-8981 (ISSN-L)
- OpenAlex
- W2063971622
- Cited by
- 3
- References
- 20
- Citations by year
- 2016: 1 · 2015: 1 · 2014: 1
- FWCI
- 0.80
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinica Chimica Acta (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
- Physical Sciences › Engineering › Electrical and Electronic Engineering › Electrochemical sensors and biosensors
- Keywords
- self-monitoring of blood glucose, blood glucose meters, Clarke error grid, measurement accuracy, glycemic variability, diabetes self-management
- MeSH terms
- Adult, Aged, Aged, 80 and over, Blood Glucose, Diabetes Mellitus, Female, Humans, Male, Middle Aged, Patient Participation, Self Care, Blood Glucose Self-Monitoring, Reproducibility of Results, Medical Laboratory Personnel, Young Adult
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