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. 2021 Jan;15(1):82-90.
doi: 10.1177/1932296819873053. Epub 2019 Sep 3.

Analysis of a Unique Postmarket Surveillance Dataset That a Glucose Test-Strip Demonstrates no Evidence of Interference and Robust Clinical Accuracy Irrespective of the Prescription Medication Status of a Large Cohort of Patients With Diabetes

Mike Grady  1 , Hilary Cameron  1 , Stuart Phillips  1 , Gillian Smith  1 , Steven Setford  1
Affiliations

Analysis of a Unique Postmarket Surveillance Dataset That a Glucose Test-Strip Demonstrates no Evidence of Interference and Robust Clinical Accuracy Irrespective of the Prescription Medication Status of a Large Cohort of Patients With Diabetes

Mike Grady et al. J Diabetes Sci Technol. 2021 Jan.

Abstract

Background: Despite a marked increase in polypharmacy in patients with diabetes there have been no thorough evaluations of the impact of polypharmacy on the accuracy of any current blood glucose monitoring (BGM) system. This study evaluated the accuracy of a BGM test-strip with respect to polypharmacy using a large clinical registry dataset.

Methods: Medication profiles were analyzed for 830 subjects (334 with type 1 [T1D] and 496 with type 2 diabetes [T2D]) attending three hospitals. Blood samples were analyzed to determine clinical accuracy of the BGM test-strip compared to a laboratory comparator.

Results: Across the 830 subjects, 473 different medications (41 diabetes and 432 nondiabetes) were recorded. Patients took on average 6.5 (n = 1-23) individual medications and 4 (n = 1-11) unique classes of medication. Clinical accuracy to EN ISO 15197:2015 criteria was met irrespective of increasing average number of individual medication, categorized from 1 to 4, 5 to 8, 9 to 12, and >12 taken per subject (97.7%, 98.4%, 98.1%, and 98.5%, respectively). Clinical accuracy to EN ISO 15197:2015 criteria was also met across 15 classes of medication using the combined dataset (98.1%; 13 003/13 253). Surveillance error grid analysis showed 98.8% (13 079/13 232) of readings presented no clinical risk. No individual class or combination of medication classes impacted clinical accuracy of the BGM test-strip.

Conclusions: This comprehensive analysis for this specific test-strip platform demonstrated no evidence of interference and robust clinical accuracy of this test strip, irrespective of the prescription medication status of patients with diabetes.

Keywords: accuracy; blood glucose monitor; medications; self-monitoring of blood glucose.

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Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MG, HC, SP, GS, and SS are all employees of LifeScan Scotland.

Figures

Figure 1.
Figure 1.
Average number of medications used by all 830 subjects.
Figure 2.
Figure 2.
Surveillance error grid plot of all individual paired medication-reference readings from the clinical registry.
Figure 3.
Figure 3.
Surveillance error grid plot of all paired medication-reference readings where the patient reported using acetaminophen.
See this image and copyright information in PMC

References

    1. Gao L, Maidment I, Matthews FE, Robinson L, Brayne C. Medication usage change in older people (65+) in England over 20 years: findings from CFAS I and CFAS II. Age Ageing. 2018;47(2):220-225. doi:10.1093/ageing/afx158 - DOI - PMC - PubMed
    1. Bauer S, Nauck MA. Polypharmacy in people with Type 1 and Type 2 diabetes is justified by current guidelines - a comprehensive assessment of drug prescriptions in patients needing inpatient treatment for diabetes-associated problems. J Diabet Med. 2014;31(9):1078-1085. doi:10.1111/dme.12497 - DOI - PubMed
    1. Heinemann L. Quality of glucose measurement with blood glucose meters at the point-of-care: relevance of interfering factors. Diabetes Technol Ther. 2010;12(11):847-857. doi:10.1089/dia.2010.0076 - DOI - PubMed
    1. Tang Z, Du X, Louie RF, Kost GJ. Effects of drugs on glucose measurements with handheld glucose meters and a portable glucose analyzer. Am J Clin Pathol. 2000;113(1):75-86. doi:10.1309/QAW1-X5XW-BVRQ-5LKQ - DOI - PubMed
    1. McEnroe RJ, Dimeski G, Durham AP. Interference Testing in Clinical Chemistry (EPO7). 3rd ed. Wayne, PA: Clinical Laboratory Standards Institute; 2018.

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