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.
accuracy
blood glucose monitor
medications
self-monitoring of blood glucose
Journal
Journal of diabetes science and technology
ISSN: 1932-2968
Titre abrégé: J Diabetes Sci Technol
Pays: United States
ID NLM: 101306166
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
pubmed:
4
9
2019
medline:
29
10
2021
entrez:
4
9
2019
Statut:
ppublish
Résumé
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. 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. Across the 830 subjects, 473 different medications (41 diabetes and 432 nondiabetes) were recorded. Patients took on average 6.5 ( 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.
Sections du résumé
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 (
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.
Identifiants
pubmed: 31478385
doi: 10.1177/1932296819873053
pmc: PMC7783023
doi:
Substances chimiques
Blood Glucose
0
Glucose
IY9XDZ35W2
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
82-90Références
Curr Med Res Opin. 2016 Sep;32(9):1519-27
pubmed: 27144490
J Diabetes Sci Technol. 2018 Mar;12(2):393-396
pubmed: 29334775
Diabetes Technol Ther. 2016 Feb;18 Suppl 2:S243-7
pubmed: 26784129
Diabetes Technol Ther. 2010 Nov;12(11):847-57
pubmed: 20879962
Age Ageing. 2018 Mar 1;47(2):220-225
pubmed: 29036509
J Diabetes Sci Technol. 2017 Sep;11(5):936-941
pubmed: 28332406
Diabet Med. 2014 Sep;31(9):1078-85
pubmed: 24824448
Sensors (Basel). 2017 Jan 14;17(1):
pubmed: 28098809
J Diabetes Sci Technol. 2014 Jul;8(4):658-72
pubmed: 25562886
Diabetes Technol Ther. 2018 May;20(5):344-352
pubmed: 29600877
Diabetes Care. 2015 Oct;38(10):e158-9
pubmed: 26269199
J Diabetes Sci Technol. 2017 Nov;11(6):1155-1162
pubmed: 28406040
J Diabetes Sci Technol. 2016 Aug 22;10(5):1161-8
pubmed: 27044519
Diabetes Care. 2018 Nov;41(11):2265-2274
pubmed: 30348844
Diabetes Care. 2019 Jan;42(Suppl 1):S61-S70
pubmed: 30559232
Am J Clin Pathol. 2000 Jan;113(1):75-86
pubmed: 10631860