Key result
FDA-cleared blood glucose monitors were significantly more likely to pass ISO 15197 2013 accuracy standards compared with non-FDA-cleared monitors (OR 2.20; 95% CI 1.51-3.27; P<0.01).
Why the study?
Are FDA-cleared blood glucose monitors more accurate than non-FDA-cleared monitors according to ISO standards?
Are FDA-cleared blood glucose monitors more accurate than non-FDA-cleared monitors according to ISO standards?
Effect estimate: OR 2.20 (95% CI 1.51-3.27)
p-value: p=< 0.01
FDA-cleared blood glucose monitors are more likely to meet ISO accuracy standards than non-cleared ones, though manufacturer-supported studies show significant bias toward reporting passing results.
May warrant preferring FDA-cleared BGMs; leaves open need for independent validation given manufacturer bias.
The aim of this study was to assess the accuracy of blood glucose monitors (BGMs) from studies reported in the medical literature. A literature review was performed of publications between 2010 and 2017 that presented data about the accuracy of BGMs using ISO 15197 2003 and/or ISO 15197 2013 as target standards. We found 58 publications describing the performance of 143 unique BGM systems, 59 of which were Food and Drug Administration (FDA) cleared. When compared with non-FDA-cleared BGMs, FDA-cleared BGMs were significantly more likely to pass both ISO 15197 2003 (OR = 2.39, CI 1.45-3.92, P < 0.01) and ISO 15197 2013 standards (OR = 2.20, CI 1.51-3.27, P < 0.01). Newer meters were more likely to pass both ISO 15197 2003 and ISO 15197 2013 standards. Many of the studies were supported by BGM manufacturers, and when compared with independent studies, an FDA-cleared BGM was significantly more likely to pass in a manufacturer-supported study for both ISO 15197 2003 (OR = 22.4, CI 8.73-21.57, P < 0.001) and ISO 15197 2013 (OR = 23.08, CI 10.16-60.03, P < 0.001). BGM accuracy should be assessed independently following regulatory clearance to ensure accurate performance. Failure to meet performance levels mandated by standards can result in deleterious clinical and economic effects.
No takes yet. Share an insight, caveat, or question.
King et al. (2018) conducted a review in Blood glucose monitoring (n=143). FDA-cleared blood glucose monitors vs. Non-FDA-cleared blood glucose monitors was evaluated on Passing ISO 15197 2013 standards (OR 2.20, 95% CI 1.51-3.27, p=< 0.01). FDA-cleared blood glucose monitors were significantly more likely to pass ISO 15197 2013 accuracy standards compared with non-FDA-cleared monitors (OR 2.20; 95% CI 1.51-3.27; P<0.01).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: