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The US Food and Drug Administration (FDA) has issued a warning about certain features advertised by smartwatches, emphasizing that devices claiming to measure blood glucose levels without skin piercing are not FDA-approved.
While wearables, including smartwatches, are commonly associated with health monitoring, the FDA has expressed concern about devices making unverified claims.
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The FDA cautions against using smartwatches or smart rings that purport to measure blood glucose levels without the need for skin penetration. For individuals managing diabetes, regular monitoring of blood sugar levels is crucial.
The FDA pointed out that while some smartwatches can monitor blood glucose, they typically rely on data from FDA-authorized devices that involve skin piercing, such as continuous glucose monitoring devices.
The organization expressed concern that these devices could provide inaccurate measurements by highlighting that the US Food and Drug Administration has not authorized any smartwatch or smart ring independently claiming to measure or estimate blood glucose values.
Such inaccuracies may lead individuals with diabetes to administer incorrect doses of insulin, sulfonylureas, or other medications that rapidly lower blood glucose.
The US Food and Drug Administration emphasized the potential dangers of taking excessive doses of these medications, which can result in dangerously low glucose levels, leading to mental confusion, coma, or even death within hours of the error.
Despite the absence of The US Food and Drug Administration approval, the organization noted that numerous companies manufacturing smartwatches and smart rings claim to measure blood glucose levels in a “non-invasive” manner.
The US Food and Drug Administration is actively working to prevent the illegal marketing of unauthorized smartwatches or smart rings that claim to measure blood glucose levels. The agency also alerts consumers about the issue, emphasizing that smartwatches and smart rings should not be relied upon for measuring blood glucose levels.
