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FDA Warns Against Smartwatches for Blood Sugar: Risks & Alternatives

The FDA has warned against the use of smartwatches and rings claiming to measure blood sugar levels without needles. These devices have not been authorised by the FDA and could be dangerous. Smartwatch apps connected to sensors for continuous glucose monitoring are not included in the warning.

The U.S. Food and Drug Administration (FDA) issued a warning on Wednesday, cautioning against the use of smartwatches and rings that claim to measure blood sugar levels without the need for needles. The FDA emphasised that these devices could be dangerous and should be avoided.


The warning applies to all smartwatches and rings, regardless of brand, that make claims about noninvasive blood glucose measurement. The FDA stated that it has not authorised any such device for medical use.


It is important to note that the FDA's notice does not include smartwatch apps that are connected to sensors, such as continuous glucose monitoring systems that directly measure blood sugar levels.


Diabetes affects approximately 37 million Americans. Individuals with diabetes struggle to regulate their blood sugar levels due to insufficient insulin production or insulin resistance. To manage their condition, they must regularly monitor their blood sugar levels through finger prick tests or continuous glucose monitoring systems that use needles placed under the skin.


Using unapproved smartwatch and smart ring devices to measure blood sugar levels could lead to inaccurate readings, which could have potentially devastating consequences. Dr. Robert Gabbay of the American Diabetes Association warned that this could result in patients taking incorrect doses of medication, leading to dangerous levels of blood sugar and potentially causing mental confusion, coma, or even death.


While there are companies working on noninvasive blood sugar measurement devices, none have yet developed a product that is accurate and secure enough to receive FDA approval. Dr. David Klonoff, a diabetes technology researcher with 25 years of experience, explained that the technology used in smartwatches and rings to measure metrics like heart rate and blood oxygen is not precise enough to measure blood sugar levels. Additionally, efforts to measure blood sugar in body fluids such as tears, sweat, and saliva are not yet ready for widespread use.


Klonoff remains optimistic, stating that he believes a scientist or engineer will eventually solve the challenge of noninvasive blood sugar measurement. In the meantime, individuals who want to accurately measure their blood sugar levels can purchase FDA-cleared blood glucose monitors from pharmacies.


Dr. Klonoff emphasised the importance of considering the risk associated with using medical devices. If a product is FDA-approved, the risk is minimal. However, using a product that has not been cleared by the FDA carries a much higher risk.

 
  • The FDA has warned against the use of smartwatches and rings claiming to measure blood sugar levels without needles.

  • These devices have not been authorised by the FDA and could be dangerous.

  • Smartwatch apps connected to sensors for continuous glucose monitoring are not included in the warning.


Source: AP NEWS

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