The FDA has warned against smartwatches and rings claiming to detect blood sugar levels non-invasively. These devices could pose risks. The alert covers all brands of watches and bands purporting needle-free blood glucose testing; none have FDA approval.
However, the warning excludes smartwatch apps linked to approved continuous glucose monitoring systems. Nearly 37 million Americans live with diabetes, a condition that impairs blood sugar regulation due to insufficient insulin production or resistance.
Patients often need to monitor their glucose through finger pricks or subcutaneous sensors. Robert Gabby from the American Diabetes Association highlights the severe risks of using unapproved devices, including incorrect medication dosages leading to potential confusion or fatal outcomes.
David Klonoff, with 25 years in diabetes technology research, notes that while companies are exploring noninvasive glucose monitoring, no device yet meets FDA standards for safety and accuracy. Furthermore, the technology in smartwatches and rings is deemed inadequate for accurate blood pressure measurement.
