Abstract
In this study, we report on the accuracy, precision and clinical acceptability of the five blood glucose meters available in India. Glucose levels of 100 blood samples were measured with each meter, at IISc health centre laboratory under same conditions and the results were compared with laboratory reference standard. In order to calculate the coefficient of variation (CV), each sample was tested three times. None of the glucometer showed 100 % compliance on CV measure. In terms of accuracy, none of the glucometer satisfied the most stringent ADA-1994 standard. In general all the glucometers showed improved accuracy with respect to the most relaxed ISO 1597:2003 standard. The Clarke error grid analysis was performed to assess the clinical acceptability of the glucometers. All five glucometers had more than 90 % of test results in Zone A and B. Bland–Altman analysis indicates that all glucometers show a positive bias, indicating that the measured values tend to be higher than the laboratory reference standard.
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Acknowledgments
We are highly thankful to Dr G.R. Nagabhushana, CMO, IISc health centre and laboratory technical staff specially Mr Rajesh, Mano madam and Manoharan Sir for their valuable help in this study.
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Appendixes
Appendixes
Details of glucometer strips used in this study
Study start date: 18 Jan 2013
Study end date: 12 Feb 2013
Glucometer | Lot No | Expiry date | Quantity |
|---|---|---|---|
Accu chek active | 23452531 | 2013-10 | 50 |
23454835 | 2013-12 | 50 | |
23452531 | 2013-10 | 50 | |
23454835 | 2013-12 | 50 | |
23452531 | 2013-10 | 50 | |
23454835 | 2013-12 | 50 | |
23453031 | 2013-12 | 50 | |
Wockhardt sugar check | TD12K101-CHE | 2014-8 | 50 |
TD12K101-CHE | 2014-8 | 50 | |
TD12K101-CHE | 2014-8 | 50 | |
TD12K101-CHE | 2014-8 | 50 | |
TD12K101-CHE | 2014-8 | 50 | |
TD12K101-CHE | 2014-8 | 50 | |
TD12K101-JHE | 2014-8 | 15 | |
One touch select simple | 3345611 | 2014-2 | 25 |
3355893 | 2014-4 | 25 | |
3366543 | 2014-5 | 25 | |
3366543 | 2014-5 | 25 | |
3366543 | 2014-5 | 25 | |
3360652 | 2014-4 | 25 | |
3360652 | 2014-4 | 25 | |
3360652 | 2014-4 | 25 | |
3373412 | 2014-5 | 25 | |
3362225 | 2014-4 | 25 | |
3334593 | 2014-2 | 25 | |
3366543 | 2014-5 | 25 | |
3360652 | 2014-4 | 25 | |
Bhatbiotech glucoscan | 391348 | 2014-5 | 25 |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
391348 | 2014-5 | 25 | |
Pulsatom GM3+ | E55 | 2013-12 | 50 |
E55 | 2013-12 | 50 | |
E55 | 2013-12 | 50 | |
E55 | 2013-12 | 50 | |
E55 | 2013-12 | 50 | |
E55 | 2013-12 | 50 | |
E48 | 2013-11 | 50 |
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Kumar, V., Indukuri, D. & Bhat, N. Analysis of five glucometers available in India. Int J Diabetes Dev Ctries 35, 189–196 (2015). https://doi.org/10.1007/s13410-014-0216-9
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DOI: https://doi.org/10.1007/s13410-014-0216-9