The Agency warns patients not to rely on glucose levels measured by the above devices unless they are reporting glucose-level data generated from an FDA-authorized device for measurement of blood glucose by a device that pierces the skin. The Agency says that readings from devices that do not puncture the skin may provide unreliable glucose levels, causing patients to take too much or too little insulin, or adjust other diabetes medication inappropriately, which “can quickly lead to dangerously low glucose, leading to mental confusion, coma, or death within hours of the error.”

Do not buy or use smartwatches or smart rings that claim to measure blood glucose levels. These devices may be sold through online marketplaces or directly from the seller. Be aware that the safety and effectiveness of these devices have not been reviewed by the FDA, and the use of these devices could result in inaccurate measurements of blood glucose levels. In the safety communication, the FDA says:

  • “Do not buy or use smartwatches or smart rings that claim to measure blood glucose levels. These devices may be sold through online marketplaces or directly from the seller.
  • Be aware that the safety and effectiveness of these devices have not been reviewed by FDA, and the use of these devices could result in inaccurate measurements of blood glucose levels.
  • If your medical care depends on accurate blood glucose measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs.”

The FDA also provides advice to healthcare providers to better assist them in properly educating their patients about this risk.

The FDA goes on to say, “These smartwatches and smart rings are manufactured by dozens of companies and sold under multiple brand names. This safety communication applies to any smartwatch or smart ring that claims to measure blood glucose without piercing the skin, regardless of manufacturer or brand.” The warning also provides information on the actions that the FDA is taking. You can read the FDA’s full safety communication here.