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FDA warns consumers that devices cannot be trusted to give accurate blood sugar measurements.
The FDA on Wednesday warned diabetes patients who use smartwatches and smart rings that claim to measure blood glucose or blood sugar levels without piercing the skin that the devices have not been authorized, cleared or approved by the FDA and cannot be trusted to give accurate blood sugar measurements, which can be deadly.
For people with diabetes, inaccurate blood glucose measurements can lead to errors in diabetes management, including taking the wrong dose of insulin, sulfonylureas, or other medications that can rapidly lower blood glucose. Taking too much of these medications can quickly lead to dangerously low glucose, leading to mental confusion, coma, or death within hours of the error.
The FDA said the unauthorized devices are different from smartwatch apps that display data from FDA-approved devices that prick the finger or pierce the skin to directly test blood sugar levels.
The agency said the devices are manufactured by dozens of companies and sold under multiple brand names. While the FDA didn’t name any specific brands advertising non-invasive blood sugar testing, below are some examples of smartwatches that currently claim to measure blood glucose or blood sugar levels without piercing the skin.
The bottom line? If your medical care depends on obtaining accurate blood glucose measurements, talk to your health care provider about devices that have been shown to work.
Find more of our coverage on products targeting diabetes patients here.
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