Patients should not use smart watches or smart rings alone to measure blood sugar levels. FDA warned on wednesday.
Non-invasive devices that do not prick the finger or pierce the skin are not licensed, licensed or approved for measuring blood sugar levels, the agency detailed in a new safety notice. As a result, these devices do not directly test blood sugar levels and may provide inaccurate readings.
“For people with diabetes, inaccurate blood glucose measurements can lead to errors in diabetes management, such as taking the wrong dose of insulin, sulfonylureas, or other drugs that can rapidly lower blood sugar.” FDA states. “Taking too much of these drugs can quickly lead to dangerous hypoglycemia, which can accidentally lead to mental confusion, coma, or death within hours.”
This warning applies to any device that does not puncture the skin, regardless of manufacturer or brand. Such devices may be sold through online marketplaces or directly from sellers.
Please note that this warning does not pertain to smartwatch applications that display blood glucose values obtained from compatible, approved devices that penetrate the skin, such as continuous glucose monitoring devices.
Healthcare providers should teach patients to rely only on FDA-approved devices to manage diabetes. You should also discuss with your patients the risks of using unapproved blood glucose monitoring devices.
The FDA said it will keep the public informed as new information becomes available. Anyone who experiences problems with inaccurate blood sugar measurements or who has an adverse event caused by an unapproved smartwatch or ring should report their experience to the FDA. MedWatch Voluntary Report Form.