A Note on the urgent need of consistent regulation for the determination of reliable pre- diabetes diagnosis, namely in the next edition of the ISO 15197.
Main Article Content
Abstract
The pre-diabetes range is defined as an A1C higher than 5.7% and lower than 6.5%, a narrow range of only 0.8% wide. Because this range is very critical for the patient's health, accurately determining if blood glucose levels stay below 125 mg/ in fasting conditions is essential. This is first assessed through home testing, then confirmed by subsequent professional tests of higher accuracy, until a sufficient statistic is reached. Significant dietary changes, already recommended when blood sugar exceeds 100 mg/dL, become even more strict and mandatory when exceeding 125 mg/dL: home testing by the patients becomes daily to determine the necessary insulin dose, as opposed to the less frequent checks originally required for pre-diabetes (typically every 3 days, which are sufficient to create reliable statistics).
The Note primarily aims to summarise the lack of clarity that patients typically find in the use of tools and in the instructions provided for performing the above-mentioned tests. Some confusion exists even in the documents supplied with the test devices in the literature and online on this subject matter. Most of these materials do not align with the procedures regulating tests in measurement science, being that the focus of the Note.
Even key documents prepared by International Bodies, namely the ISO 15197-2015, are suggested in the Note as urgently requiring more specific information and guidelines, especially in the extremely critical pre-diabetes range (only 25 mg/dL wide), a condition shared by a large number of patients being exempt from the full disease and not classified yet as affected by it—a last stage that they might actually never reach in the rest of their lifetime.
Article Details
How to Cite
PAVESE, Franco.
A Note on the urgent need of consistent regulation for the determination of reliable pre- diabetes diagnosis, namely in the next edition of the ISO 15197..
Medical Research Archives, [S.l.], v. 13, n. 8, aug. 2025.
ISSN 2375-1924.
Available at: <https://esmed.org/MRA/mra/article/view/6697>. Date accessed: 05 dec. 2025.
doi: https://doi.org/10.18103/mra.v13i8.6697.
Section
Research Articles
The Medical Research Archives grants authors the right to publish and reproduce the unrevised contribution in whole or in part at any time and in any form for any scholarly non-commercial purpose with the condition that all publications of the contribution include a full citation to the journal as published by the Medical Research Archives.
References
1. Pavese F. Findings from a Metrological Analysis of Test-Strip Use in Diabetes Home-Care Control: A Confirmation. Clinical Cases in Medicine. Medtext Publications. 2022;2(Article 1016): 24-26. ISSN: 2770-2359.
2. Pavese F. A long-term case study on marginal diabetes: demonstrating the need for effective calibration of home test devices. Medical Research Archives [S.l.]. 2024;12(9) 1–7. ISSN 2375-1924. Available at: https://esmed.org/MRA/mra/article/view/5873.
3. Pavese F. A testing/metrological look at the accuracy of glucose strip measurements in home care for marginal diabetes, for mitigating diabetic kidney disease. J. of Nephrology. 2022; 35023077: 1– 5. Doi: 10.1007/s40620-021-01224-6.
4. Pavese F. Further Problems in Tester Calibration and Control Solution in Home Monitoring of Pre-Diabetes. Medical Research Archives. 2025;13(6) 1–5. https://doi.org/10.18103/mra.v13i6.6516
5. BS EN ISO 15197:2015. Document consulted: ® Tracked Changes, compares BS EN ISO 15197:2015 and BS EN ISO 15197:2013: In vitro diagnostic test systems — Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus. © The British Standards Institution 2019. Published by BSI Standards Limited 2019.
6. https://www.mayoclinic.org/tests-procedures/glucose-tolerance-test/about/pac-20394296
7. JCTLM database: Laboratory medicine and in vitro diagnostics, Database of higher-materials, measurement methods/procedures and services (Bureau International des Poids et Measures (BIPM), Sèvres France). Available at http://www.bipm.org/jctlm/.
8. BSI, Standard Publications: BS EN ISO 15197:2015 – Tracked Changes. Compares BS EN ISO 15197:2015 and BS EN ISO 15197:2013: In vitro diagnostic test systems — Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus. 2015 European Committee for Standardisation (CEN).
9. Parkes JL. et al. A new consensus error grid to evaluate the clinical significance in the measurement of blood-glucose. Care. 2000;(8) pp. 1143–1148.
APPENDIX [Not Reported in the Paper Text]
10. T. K. Mathew, M. Zubair, P. Tadi, Blood Glucose Monitoring, NIH 2023, National Library of Medecine Treasure Island (FL): StatPearls Publishing; 2025 Jan https://www.ncbi.nlm.nih.gov/books/NBK555976/
11. American Diabetes Association, Blood Glucose & A1C: Understanding Diabetes Diagnosis, https://diabetes.org/about-diabetes/diagnosis
12. F. King, D. Ahn, V. Hsiao, T. Porco, D. C. Klonoff, A review of blood glucose monitor accuracy, Diabetes Technology & Therapeutics 20 (12) 2018 pp.1-20. https://doi.org/10.1089/dia.2018.0232
13. C. Sonmez, A. D. Babacan, N. Akkaya, A. O. Kaymak, G. Sasmaz, K. O. Akin, The evaluation of Accu-Check Inform II® and hexokinase method in emergency departments for glucose measurement, Gazi Medical Journal, Apr 2015. Doi:10.12996/gmj2015.18
14. H. Hall, D. Perelman, A. Breschi, P. Limcaoco, R. Kellogg, T. McLaughlin, M. Snyder, Glucotypes reveal new patterns of glucose dysdegulation, PLOS Biology 16(7) 2018 pp.1-23: e2005143. https://doi.org/10.1371/journal.pbio.2005143
15. S. Pleus, A. Baumstark, N. Jendrike, J. Mende, M. Link, E. Zschornack, C. Haug, G. Freckmann, System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015, pp.1-10. BMJ Open Diabetes Research & Care 2020;8:e001067. Doi:10.1136/bmjdrc-2019-001067.
16. D. C. Klonoff, J. L. Parkers, B. P. Kovatchev, D. Kerr, W. C. Bevier, R. L. Brazg, M. Christiansen, T. S. Bailey, J. H. Nichols, M. A. Kohn, Investigation of the accuracy of 18 marketed blood glucose monitors. Diabetes Care 41 pp. 1681-1688, 2018. http://doi.org/10.2337/dc17-1960 With supplementary data.
17. N. Jendrike, A. Baustark, U. Kamecke, C. Haug, G. Freckmann, ISO 15197:213 Evaluation of a blood glucose monitoring system’s measurement accuracy. Letter. J. Of Diabetes Science and Technology 11(6) 2017 pp. 1275-1276. From Doi:10.1177/1932296817727550.
18. E. Renard, Monitoring glycemic control: the importance of self-monitoring of blood glucose. Am J Med 2005; 118:S12-9.
19. American Diabetes Association. Standards of medical care in diabetes 2008. Diabetes Care 2008; 31(suppl 1):S12-54.
20. D. B. Sacks, D. E. Bruns, D. E. Goldstein, et al., Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2002; 48:436-72.
21. A. J. Karter, L. M. Ackerson, J. A. Darbinian, et al., Self-monitoring of blood glucose levels and glycemic control: the Northen California Kaiser Permanent Diabetes Registry. Am J Med 2001; 111:1-9.
22. J. M. M. Evans, R. W. Newton, D. A. Ruta, et al., Frequency of blood glucose monitoring in relation to glycemic control: observation study with diabetes database. Br Med J 1999; 319:83-6.
23. R. M. Reynolds, D. J. Webb, Recommendations and conclusions from a mini-symposium on self-blood glucose monitoring. J R Coll Physicians Edinb 2006; 36:155-8.
24. Consensus statement on self-monitoring in diabetes: institute of health economics, Alberta, Canada. Int J Technol Assess Health Care 2007; 23:146-51.
25. R. M. Reynolds, M. W. J. Strachan, Home blood glucose monitoring in type 2 diabetes. Br Med J 2004; 326:754-5.
26. L. M. C. Welschen, E. Bloemendal, G. Nijpels, et al., Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin: a systematic review. Diabetes Care 2005; 28:1510-7.
27. J. L. Meier, L. M. Swislocki, J. R. Lopez, et al., Reduction in self monitoring of blood glucose in persons with type 2 diabetes results in cost savings and no change in glycemic control. Am J Managed Care 2002; 8:557-65.
28. U. Schwedes, M. Siebolds, Meal-related structured self-monitoring of blood glucose: effects on diabetes control in non-insulin-treated type 2 diabetic patients. Diabetes Care 2002; 25:1928-32.
29. J. N. Sarol, J. N. Nicodemus NA, K. M. Tan, et al., Self-monitoring of blood glucose as part of a multi-component therapy among non-insulin requiring type 2 diabetes patients: a meta-analysis (1966-2004). Curr Med Res Opin 2005; 21:173-83.
30. M. Schûtt, W. Kern, U. Krause, et al., Is the frequency of self¬monitoring of blood glucose related to long-term metabolic control? Multicenter analysis including 24500 patients form 191 centers in Germany and Austria. Exp Clin Endocrinol Diabetes 2006; 114:384-8.
31. J. A. Johnson, S. R. Majumdar, S. L. Bowker, et al., Self monito-ring in type 2 diabetes: a randomized trial of reimbursement policy. Diabet Med 2006; 23:1247-51.
32. K. Kempf, W. Neukirchen, S. Martin, et al., Self-monitoring of blood glucose in type 2 diabetes: a new look at published trials. Diabetologia 2008; 51:686-8.
33. E. Peel, M. Douglas, J. Lawton. Self monitoring of blood glucose in type 2 diabetes: longitudinal qualitative study of patients' perspectives. Br Med J 2007; 335;493.
34. P. D’Orazio, R. W. Burnett, N. Fogh-Andersen, et al., 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. Clin Chem 2005; 51:1573-1576.
35. R. W. Burnett, P. D’Orazio, N. Fogh-Andersen, et al., IFCC recommendation on reporting results for blood glucose. Clin Chim Acta 2001; 307:205-9.
36. G. B. Kristensen, K. Nerhus, G. Thue, et al., Standardized evaluation of instruments for self-monitoring of blood glucose by patients and a technologist. Clin Chem 2004; 50:1068-71.
37. D. E. Goldstein, R. R. Little, R. A. Lorenz, et al., American Diabetes Association. Tests of glycemia in diabetes. Diabetes Care 2004; 27(suppl 1):S91-3.
38. National Committee for Clinical Laboratory Standards. Ancillary (bedside) blood glucose testing acute and chronic care facilities; approved guidelines.Villanova, PA: NCCLS 1994.
39. American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care 1996;19(suppl 1):S62-6.
40. International Organization for Standardization. In vitro diagnostic test systems-requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. ISO/TC 212/SC. Final Draft International Standard ISO/FDIS 15197. Geneva: ISO, 2003.
41. G. J. Kost, R. Louie, N. Veerasamy, et al., Meeting the challenge of the International Standard ISO 15197 for capillary glucose accuracy. Clin Chem 2005; 51:A255.
42. National Committee for Clinical Laboratory Standards. Point-of-care blood-glucose testing in acute and chronic care facilities; approved guideline, 2nd ed. Wayne, PA: NCCLS, 2002.
43. G. J. Kost, H. T. Vu, J. H. Lee, et al., Multicenter study of oxygen-insensitive handheld glucose point-of-care testing in critical care/hospital/ambulatory patients in the United States and Canada. Crit Care Med 1998; 26:581-90.
44. K. Lewandrowski, R. Cheek, D. M. Nathan, et al., Implementation of capillary blood glucose monitoring in a teaching hospital and determination of program requirements to maintain quality testing. Am J Med 1992; 93:419
45. R. Bamberg, K. Schulman, M. MacKenzie, et al., Effect of adverse storage conditions on performance of glucometer test strips. Clin Lab Sci 2005; 18:203-9.
46. K. Wiener. Potential for error from underfilling glucometer Elite test strips. Diabet Med 2000; 17:555-6.
47. American Diabetes Association. Consensus statement on self-monitoring of blood glucose. Diabetes Care 1994; 17:81-6.
48. P. B. Barreau, J. E. Buttery, Effect of hematocrit concentration on blood glucose value determined on Glucometer II. Diabetes Care 1988; 11:116-8.
49. L.V. Rao, F. Jakubiak, J. S. Sidwell, et al., Accuracy evaluation of a new glucometer with automated hematocrit measurement and correction. Clin Chim Acta 2005; 356:178-83.
50. P. Carraro, M. Plebani. Post-analytical errors with portable glucose meters in the hospital setting. Clin Chim Acta 2009; 404:65-7.
2. Pavese F. A long-term case study on marginal diabetes: demonstrating the need for effective calibration of home test devices. Medical Research Archives [S.l.]. 2024;12(9) 1–7. ISSN 2375-1924. Available at: https://esmed.org/MRA/mra/article/view/5873.
3. Pavese F. A testing/metrological look at the accuracy of glucose strip measurements in home care for marginal diabetes, for mitigating diabetic kidney disease. J. of Nephrology. 2022; 35023077: 1– 5. Doi: 10.1007/s40620-021-01224-6.
4. Pavese F. Further Problems in Tester Calibration and Control Solution in Home Monitoring of Pre-Diabetes. Medical Research Archives. 2025;13(6) 1–5. https://doi.org/10.18103/mra.v13i6.6516
5. BS EN ISO 15197:2015. Document consulted: ® Tracked Changes, compares BS EN ISO 15197:2015 and BS EN ISO 15197:2013: In vitro diagnostic test systems — Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus. © The British Standards Institution 2019. Published by BSI Standards Limited 2019.
6. https://www.mayoclinic.org/tests-procedures/glucose-tolerance-test/about/pac-20394296
7. JCTLM database: Laboratory medicine and in vitro diagnostics, Database of higher-materials, measurement methods/procedures and services (Bureau International des Poids et Measures (BIPM), Sèvres France). Available at http://www.bipm.org/jctlm/.
8. BSI, Standard Publications: BS EN ISO 15197:2015 – Tracked Changes. Compares BS EN ISO 15197:2015 and BS EN ISO 15197:2013: In vitro diagnostic test systems — Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus. 2015 European Committee for Standardisation (CEN).
9. Parkes JL. et al. A new consensus error grid to evaluate the clinical significance in the measurement of blood-glucose. Care. 2000;(8) pp. 1143–1148.
APPENDIX [Not Reported in the Paper Text]
10. T. K. Mathew, M. Zubair, P. Tadi, Blood Glucose Monitoring, NIH 2023, National Library of Medecine Treasure Island (FL): StatPearls Publishing; 2025 Jan https://www.ncbi.nlm.nih.gov/books/NBK555976/
11. American Diabetes Association, Blood Glucose & A1C: Understanding Diabetes Diagnosis, https://diabetes.org/about-diabetes/diagnosis
12. F. King, D. Ahn, V. Hsiao, T. Porco, D. C. Klonoff, A review of blood glucose monitor accuracy, Diabetes Technology & Therapeutics 20 (12) 2018 pp.1-20. https://doi.org/10.1089/dia.2018.0232
13. C. Sonmez, A. D. Babacan, N. Akkaya, A. O. Kaymak, G. Sasmaz, K. O. Akin, The evaluation of Accu-Check Inform II® and hexokinase method in emergency departments for glucose measurement, Gazi Medical Journal, Apr 2015. Doi:10.12996/gmj2015.18
14. H. Hall, D. Perelman, A. Breschi, P. Limcaoco, R. Kellogg, T. McLaughlin, M. Snyder, Glucotypes reveal new patterns of glucose dysdegulation, PLOS Biology 16(7) 2018 pp.1-23: e2005143. https://doi.org/10.1371/journal.pbio.2005143
15. S. Pleus, A. Baumstark, N. Jendrike, J. Mende, M. Link, E. Zschornack, C. Haug, G. Freckmann, System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015, pp.1-10. BMJ Open Diabetes Research & Care 2020;8:e001067. Doi:10.1136/bmjdrc-2019-001067.
16. D. C. Klonoff, J. L. Parkers, B. P. Kovatchev, D. Kerr, W. C. Bevier, R. L. Brazg, M. Christiansen, T. S. Bailey, J. H. Nichols, M. A. Kohn, Investigation of the accuracy of 18 marketed blood glucose monitors. Diabetes Care 41 pp. 1681-1688, 2018. http://doi.org/10.2337/dc17-1960 With supplementary data.
17. N. Jendrike, A. Baustark, U. Kamecke, C. Haug, G. Freckmann, ISO 15197:213 Evaluation of a blood glucose monitoring system’s measurement accuracy. Letter. J. Of Diabetes Science and Technology 11(6) 2017 pp. 1275-1276. From Doi:10.1177/1932296817727550.
18. E. Renard, Monitoring glycemic control: the importance of self-monitoring of blood glucose. Am J Med 2005; 118:S12-9.
19. American Diabetes Association. Standards of medical care in diabetes 2008. Diabetes Care 2008; 31(suppl 1):S12-54.
20. D. B. Sacks, D. E. Bruns, D. E. Goldstein, et al., Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2002; 48:436-72.
21. A. J. Karter, L. M. Ackerson, J. A. Darbinian, et al., Self-monitoring of blood glucose levels and glycemic control: the Northen California Kaiser Permanent Diabetes Registry. Am J Med 2001; 111:1-9.
22. J. M. M. Evans, R. W. Newton, D. A. Ruta, et al., Frequency of blood glucose monitoring in relation to glycemic control: observation study with diabetes database. Br Med J 1999; 319:83-6.
23. R. M. Reynolds, D. J. Webb, Recommendations and conclusions from a mini-symposium on self-blood glucose monitoring. J R Coll Physicians Edinb 2006; 36:155-8.
24. Consensus statement on self-monitoring in diabetes: institute of health economics, Alberta, Canada. Int J Technol Assess Health Care 2007; 23:146-51.
25. R. M. Reynolds, M. W. J. Strachan, Home blood glucose monitoring in type 2 diabetes. Br Med J 2004; 326:754-5.
26. L. M. C. Welschen, E. Bloemendal, G. Nijpels, et al., Self-monitoring of blood glucose in patients with type 2 diabetes who are not using insulin: a systematic review. Diabetes Care 2005; 28:1510-7.
27. J. L. Meier, L. M. Swislocki, J. R. Lopez, et al., Reduction in self monitoring of blood glucose in persons with type 2 diabetes results in cost savings and no change in glycemic control. Am J Managed Care 2002; 8:557-65.
28. U. Schwedes, M. Siebolds, Meal-related structured self-monitoring of blood glucose: effects on diabetes control in non-insulin-treated type 2 diabetic patients. Diabetes Care 2002; 25:1928-32.
29. J. N. Sarol, J. N. Nicodemus NA, K. M. Tan, et al., Self-monitoring of blood glucose as part of a multi-component therapy among non-insulin requiring type 2 diabetes patients: a meta-analysis (1966-2004). Curr Med Res Opin 2005; 21:173-83.
30. M. Schûtt, W. Kern, U. Krause, et al., Is the frequency of self¬monitoring of blood glucose related to long-term metabolic control? Multicenter analysis including 24500 patients form 191 centers in Germany and Austria. Exp Clin Endocrinol Diabetes 2006; 114:384-8.
31. J. A. Johnson, S. R. Majumdar, S. L. Bowker, et al., Self monito-ring in type 2 diabetes: a randomized trial of reimbursement policy. Diabet Med 2006; 23:1247-51.
32. K. Kempf, W. Neukirchen, S. Martin, et al., Self-monitoring of blood glucose in type 2 diabetes: a new look at published trials. Diabetologia 2008; 51:686-8.
33. E. Peel, M. Douglas, J. Lawton. Self monitoring of blood glucose in type 2 diabetes: longitudinal qualitative study of patients' perspectives. Br Med J 2007; 335;493.
34. P. D’Orazio, R. W. Burnett, N. Fogh-Andersen, et al., 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. Clin Chem 2005; 51:1573-1576.
35. R. W. Burnett, P. D’Orazio, N. Fogh-Andersen, et al., IFCC recommendation on reporting results for blood glucose. Clin Chim Acta 2001; 307:205-9.
36. G. B. Kristensen, K. Nerhus, G. Thue, et al., Standardized evaluation of instruments for self-monitoring of blood glucose by patients and a technologist. Clin Chem 2004; 50:1068-71.
37. D. E. Goldstein, R. R. Little, R. A. Lorenz, et al., American Diabetes Association. Tests of glycemia in diabetes. Diabetes Care 2004; 27(suppl 1):S91-3.
38. National Committee for Clinical Laboratory Standards. Ancillary (bedside) blood glucose testing acute and chronic care facilities; approved guidelines.Villanova, PA: NCCLS 1994.
39. American Diabetes Association. Self-monitoring of blood glucose. Diabetes Care 1996;19(suppl 1):S62-6.
40. International Organization for Standardization. In vitro diagnostic test systems-requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. ISO/TC 212/SC. Final Draft International Standard ISO/FDIS 15197. Geneva: ISO, 2003.
41. G. J. Kost, R. Louie, N. Veerasamy, et al., Meeting the challenge of the International Standard ISO 15197 for capillary glucose accuracy. Clin Chem 2005; 51:A255.
42. National Committee for Clinical Laboratory Standards. Point-of-care blood-glucose testing in acute and chronic care facilities; approved guideline, 2nd ed. Wayne, PA: NCCLS, 2002.
43. G. J. Kost, H. T. Vu, J. H. Lee, et al., Multicenter study of oxygen-insensitive handheld glucose point-of-care testing in critical care/hospital/ambulatory patients in the United States and Canada. Crit Care Med 1998; 26:581-90.
44. K. Lewandrowski, R. Cheek, D. M. Nathan, et al., Implementation of capillary blood glucose monitoring in a teaching hospital and determination of program requirements to maintain quality testing. Am J Med 1992; 93:419
45. R. Bamberg, K. Schulman, M. MacKenzie, et al., Effect of adverse storage conditions on performance of glucometer test strips. Clin Lab Sci 2005; 18:203-9.
46. K. Wiener. Potential for error from underfilling glucometer Elite test strips. Diabet Med 2000; 17:555-6.
47. American Diabetes Association. Consensus statement on self-monitoring of blood glucose. Diabetes Care 1994; 17:81-6.
48. P. B. Barreau, J. E. Buttery, Effect of hematocrit concentration on blood glucose value determined on Glucometer II. Diabetes Care 1988; 11:116-8.
49. L.V. Rao, F. Jakubiak, J. S. Sidwell, et al., Accuracy evaluation of a new glucometer with automated hematocrit measurement and correction. Clin Chim Acta 2005; 356:178-83.
50. P. Carraro, M. Plebani. Post-analytical errors with portable glucose meters in the hospital setting. Clin Chim Acta 2009; 404:65-7.