The Food and Drug Administration (FDA) has issued a press release to warn against using wearable devices to measure blood glucose levels.
Currently, in fact, there are no devices approved for blood glucose measurement that do not require blood sampling, and any wearable device that claims to do so is not approved and could put the health of the user at risk.
These devices are very different from smartwatch applications that display data collected from approved devices, such as continuous glucose monitoring devices (CGM).
The warning applies to any smartwatch or smart ring that claims to measure the level of glucose without blood draw.
Rumors report that tech giants like Apple and Samsung are working on non-vasive wearable technology, but the results have not yet been shared.
Important consequences in the use of unapproved devices
Misconceptions, in fact, could lead people with diabetes to take the wrong dose of insulin or other drugs used to lower their blood glucose level. This, in turn, increases the risk of hypoglycemia, which can lead to mental confusion, coma or even death within a few hours.
The unapproved devices are for sale online and through social media channels, and a summary search on various e-commerce sites, including eBay, AliExpress and Wish, has revealed the existence of dozens of ads for devices that claim to offer blood glucose monitoring, as well as other unrealistic measurements such as blood lipids and uric acid levels.
Manufacturers of these devices often try to circumvent FDA regulations that affect medical devices by specifying that they are not regulated – for example, writing “this is not a medical device” on the packaging.
But that is not enough. The regulations clearly indicate that any device that claims to diagnose, treat or prevent a disease or affect a body function – and is not a drug – falls into the category of medical devices and must go through the normal approval process.
The illegal import, distribution or sale of unapproved medical devices can lead to seizure of goods, as well as penalties of thousands to millions of dollars, and even criminal complaints.
Read more: Apple WatchOS 11 revolutionizes health and fitness
