Key result
FDA-cleared blood glucose monitors were more likely to meet ISO 15197 2013 accuracy standards compared to non-FDA-cleared monitors (48.3% vs 23%; P=0.003), though overall accuracy remains poor.
Why the study?
Do FDA-cleared blood glucose monitor systems perform more accurately according to ISO standards compared to non-FDA-cleared systems?
Population
11 publications describing performance of 98 unique blood glucose monitor (BGM) systems
Comparison
FDA-cleared BGM systems vs Non-FDA-cleared BGM systems
Design
Review
Authors
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May warrant caution selecting any glucose monitor; leaves open whether current regulatory standards ensure reliable accuracy.
Do FDA-cleared blood glucose monitor systems perform more accurately according to ISO standards compared to non-FDA-cleared systems?
Absolute Event Rate: 48.3% vs 23%
p-value: p=0.003
A significant proportion of cleared blood glucose monitors do not meet international accuracy standards, though FDA-cleared devices perform better than non-cleared ones.
Klonoff et al. (2015) conducted a review in Blood glucose monitoring accuracy (n=98). FDA-cleared blood glucose monitor (BGM) systems vs. Non-FDA-cleared BGM systems was evaluated on Meeting ISO 15197 2013 analytical accuracy standards in all evaluated studies (p=0.003). FDA-cleared blood glucose monitors were more likely to meet ISO 15197 2013 accuracy standards compared to non-FDA-cleared monitors (48.3% vs 23%; P=0.003), though overall accuracy remains poor.
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