FDA Issues Warning Regarding Use of Specific Smartwatches and Rings for Blood Glucose Monitoring.
The U.S. Food and Drug Administration (FDA) has issued a warning stating that smartwatches and rings that do not penetrate the skin may not provide reliable blood glucose level readings. This caution was outlined in a news release published on Wednesday.
In the release, the FDA advises consumers and caregivers that non-invasive smartwatches and rings can lead to errors in diabetes management and the administration of correct medication dosages.
According to the FDA, only smartwatches and rings authorized by the agency, which utilize devices that penetrate the skin for continuous glucose monitoring, can deliver accurate and dependable measurement data.
The FDA strongly recommends individuals whose medical care relies on precise blood glucose readings to consult their healthcare providers regarding FDA-authorized devices that are suitable for their needs.
The FDA warns that relying on data from unauthorized smartwatches and rings may result in the incorrect administration of insulin, sulfonylureas, or other medications designed to rapidly lower blood glucose levels. Overdosing on these medications can lead to dangerously low glucose levels in individuals with diabetes, potentially resulting in mental confusion, coma, or even death within hours.
The FDA highlights that sellers of these non-authorized smartwatches and rings claim that their devices can measure blood glucose levels without the need for finger pricks or skin penetration, using supposed non-invasive techniques. However, the FDA clarifies that these devices do not directly test blood glucose levels.
Although the FDA does not specify particular brands, it emphasizes that sellers of these unauthorized smartwatches and rings advertise the use of “non-invasive techniques” for blood glucose monitoring without requiring finger pricks or skin penetration. Nevertheless, the FDA urges consumers to refrain from purchasing these devices for this purpose, as they do not provide direct blood glucose level testing.
Furthermore, the FDA advises healthcare providers to discuss the risks associated with using unauthorized blood glucose measurement devices with their patients and assist them in selecting an appropriate FDA-authorized device.
The FDA assures the public that it is taking measures to prevent the unlawful marketing of unauthorized smartwatches and rings that claim to measure blood glucose levels by manufacturers, distributors, and sellers.
Consumers who experience adverse events or encounter issues related to inaccurate blood glucose measurement resulting from the use of unauthorized smartwatches or rings can report them through the FDA MedWatch Voluntary Reporting Form.