This week, the Food and Drug Administration warned consumers about smartwatches or rings advertising needle-free measurements for blood sugar measurements. According to regulators, a device would need to piece skin in order to check the health metric safely and accurately.
Roughly 37 million American diabetes patients require routine blood sugar monitoring to manage the disease. However, the FDA has yet to approve any substitute for finger prick tests or inserted skin sensors.
Relying on unvalidated smartwatch data poses “potentially devastating” consequences, added experts. Due to incorrect levels, patients may administer disastrously wrong medication doses resulting in coma, confusion, or even death.
Multiple companies are pursuing substitutes for skin pricking. However, the current watches cannot reliably extrapolate blood sugar from other biometrics like heart rate. Analyzing bodily fluids doesn’t work well enough, either.
“It’s challenging, and I believe at some point there will be at least one scientist or engineer to solve it,” Dr. Klonoff asserted. Still, achieving the accuracy and consistency for FDA approval remains an elusive obstacle.
Klonoff says the current smartwatches are too risky to meet the FDA’s standards.
In the meantime, the FDA strongly cautions against trusting stylish but unproven wellness gadgets for vital medical purposes like diabetes care. Patients shouldn’t compromise safety due to alluring features or designs.
Instead, the FDA urges utilizing already cleared meters and sensors available at pharmacies until future potential alternatives garner full federal validation. Diabetes requires diligent daily attention, but science cannot yet deliver this advancement. For now, proven pricks must persist.
The Associated Press contributed to this article.