Dive Brief:
- The Food and Drug Administration warned patients against using smartwatches or smart rings that claim to measure blood sugar without piercing the skin.
- Officials published the safety notice Wednesday after learning that people are selling wearables that claim to noninvasively monitor blood glucose. The devices are “manufactured by dozens of companies and sold under multiple brand names,” according to the agency.
- The FDA has never authorized a noninvasive wearable that measures or estimates blood glucose values on its own and is concerned inaccurate readings could lead to errors in the management of diabetes.
Dive Insight:
Samsung is working to add noninvasive glucose monitoring to its smartwatches and Apple reportedly set up a group focused on the challenge years ago. Google’s life science group,Verily, disclosed a push to create a contact lens that can measure blood sugar in 2014 but stopped work in 2018 after tests showed “insufficient consistency” between the concentration of glucose in tears and blood.
While some of the biggest companies on earth have so far failed to create noninvasive glucose monitors, little-known brands are selling smartwatches and rings that claim to track blood sugar for less than $50 online. The FDA became aware of unauthorized products being marketed to consumers through routine monitoring of the medical device market.
Because the FDA has never assessed the devices, the smartwatches and smart rings may give inaccurate blood glucose measurements that “lead to errors in diabetes management, including taking the wrong dose of insulin, sulfonylureas or other medications that can rapidly lower blood glucose,” the agency said. Dosing errors can lead to “mental confusion, coma or death within hours.”
In response, the agency told consumers not to buy such devices and be aware that it has not reviewed their safety and effectiveness. The FDA is asking healthcare providers to talk to their patients about the risks of using unauthorized devices. Officials are encouraging anyone who has a problem with inaccurate blood sugar findings or adverse events linked to unauthorized wearables to file a report.
As well as alerting consumers and physicians to the issue, the FDA is working to ensure “manufacturers, distributors and sellers do not illegally market unauthorized smartwatches or smart rings that claim to measure blood glucose levels,” the agency said.
