The US Food and Drug Administration issued a warning on Wednesday regarding the potential hazards associated with smartwatches and rings that are used to measure blood sugar levels for medical purposes without penetrating the skin.
The caution pertains to any smartwatch or ring, irrespective of brand, that claims to gauge blood glucose levels in a noninvasive manner, as stated by the agency.
The FDA emphasized that it has not sanctioned any such device for medical use.
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The advisory from the agency does not encompass smartwatch applications connected to sensors, such as continuous glucose monitoring systems, which directly measure blood sugar levels.
Risks of Non-FDA Smartwatch Blood Sugar Monitoring
Using unauthorized smartwatch and smart ring devices for this purpose could yield inaccurate blood sugar readings, potentially leading to severe consequences, as noted by Dr. Robert Gabbay from the American Diabetes Association.
Such inaccuracies might prompt patients to administer incorrect medication dosages, resulting in hazardous blood sugar levels and potentially severe outcomes such as mental confusion, coma, or even fatality.
While several companies are endeavoring to develop noninvasive devices for blood sugar measurement, none have yet produced a product deemed sufficiently accurate and secure to obtain FDA approval, according to Dr. David Klonoff, a diabetes technology researcher with 25 years of experience.
Challenges of Blood Sugar Regulation in Diabetes
Approximately 37 million individuals in the United States have diabetes.
Those affected by the condition encounter challenges in effectively regulating their blood sugar due to insufficient production of the hormone insulin by their bodies or insulin resistance.
To manage their condition effectively, individuals with diabetes must routinely monitor their blood sugar levels using either a finger prick blood test or a sensor implanted just beneath the skin, enabling continuous glucose level monitoring.
Current technology used in smartwatches and rings, designed for measuring metrics like heart rate and blood oxygen levels, lacks the precision necessary for blood sugar measurement.
Furthermore, efforts to measure blood sugar in bodily fluids such as tears, sweat, and saliva are not yet advanced enough for practical use.