In what will come as a temporary blow to the likes of Apple, Samsung and others, the US Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin. While neither the Apple Watch nor any other smartwatch has blood sugar monitoring feature, rumours suggest it has been in pipeline for a while.
According to the FDA, these devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGMs). “The FDA has not authorised, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own,” said the government body in a press release.
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,” said the FDA.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.
There have been some devices that claim to monitor blood sugar levels. Sellers of these smartwatches and smart rings claim their devices measure blood glucose levels without requiring people to prick their finger or pierce the skin. “They claim to use non-invasive techniques. These smartwatches and smart rings do not directly test blood glucose levels. These smartwatches and smart rings are manufactured by dozens of companies and sold under multiple brand names. The agency is working to ensure that manufacturers, distributors, and sellers do not illegally market unauthorised smartwatches or smart rings that claim to measure blood glucose levels