The US Food and Drug Administration (FDA) issued a strong warning recently advising consumers not to use smartwatches or
wearable devices
that claim to measure
blood sugar levels
without piercing the skin. The agency said that these devices can provide inaccurate results, leading diabetes patients and others to take incorrect doses of medication.
In its safety communication, the FDA said it has not authorised or approved any
smartwatch
,
smart ring
, or other wearable device to measure blood glucose without puncturing the skin first.
The agency said it is working to stop illegal marketing of unauthorised products making unproven medical claims.
“The FDA is concerned that people may rely on these unauthorised devices for managing diabetes without consulting a health care provider, which could lead to poor diabetes management and potential harm,” the agency said.
Inaccurate blood sugar level readings could cause users to administer incorrect insulin doses, resulting in complications like hypoglycemia, diabetic ketoacidosis, or even death in extreme cases, according to the FDA.
The regulator said the only wrist-worn devices currently approved for diabetes management are those that connect to an FDA-cleared continuous glucose monitor with a sensor inserted under the skin. These devices display data collected from the under-skin sensor but do not measure blood glucose themselves.
Smartwatch and smart rings with blood sugar monitoring in the market
Apple
and
Samsung
have for years sought to develop non-invasive blood glucose monitoring for wearables like smartwatches. But valid clinical testing and approval from regulators could still be years away from realisation.
Even though there are not any smartwatches and smart rings from major brands that claim to measure blood glucose, a quick search on Google and Amazon revealed quite a few products that do promise to measure the wearer’s blood glucose.
In the meantime, the FDA advised patients with diabetes not to use any smartwatch or wearable that directly claims to measure blood sugar without a skin prick. Doing so could have “serious health consequences,” it warned.
Patients and caregivers who find smartwatches or wearables making dubious marketing claims about blood glucose testing should report them to the FDA’s MedWatch program, regulators advised. The agency said companies promoting or selling unauthorised medical products could face regulatory action, it added.
English (US) ·