FDA Advises Against Smartwatches and Rings Making Needle-Free Blood Sugar Measurement Claims

FDA Advises Against Smartwatches and Rings Making Needle-Free Blood Sugar Measurement Claims

Asif Iqbal | February 22, 2024 | 03:08 PM IST | Health | Follow on Google News

FDA Advises Against Smartwatches and Rings Making Needle-Free Blood Sugar Measurement Claims

FDA Advises Against Smartwatches and Rings Making Needle-Free Blood Sugar Measurement Claims

Smartwatches and rings claiming to measure blood sugar levels without piercing the skin could pose serious health risks, the U.S. Food and Drug Administration (FDA) cautioned on Wednesday.

FDA Caution on Noninvasive Devices

Regardless of the brand, the FDA emphasized that any smartwatch or ring asserting noninvasive blood glucose level measurement has not received authorization from the agency. The warning is a response to the growing market of such devices, which, the FDA contends, may provide inaccurate readings.

Exclusion of Approved Smartwatch Apps

The FDA’s notice does not extend to smartwatch apps connected to sensors, such as continuous glucose monitoring systems directly measuring blood sugar. However, the caution emphasizes the lack of approval for standalone noninvasive devices.

Roughly 37 million Americans with diabetes face challenges in regulating their blood sugar levels. Traditional methods involve finger prick tests or continuous monitoring with sub-skin needles. The FDA warns that reliance on unapproved smartwatch and smart ring devices could lead to inaccurate readings, potentially resulting in harmful consequences.

Health Risks and Consequences

Dr. Robert Gabbay from the American Diabetes Association warns that inaccurate blood sugar measurements from unapproved devices could have “potentially devastating” outcomes. Patients might administer incorrect doses of medication, leading to dangerous blood sugar levels, mental confusion, coma, or even death.

Renowned diabetes technology researcher Dr. David Klonoff notes that despite ongoing efforts to develop noninvasive blood sugar measurement devices, none have secured FDA approval. The technology used in current smartwatches and rings, designed for metrics like heart rate and blood oxygen, lacks the accuracy required for measuring blood sugar levels.

Challenges in Noninvasive Measurement Technology

Klonoff, with 25 years of diabetes technology research, states that measuring blood sugar accurately through tears, sweat, or saliva is not yet ready for mainstream use. While optimistic about future solutions, he acknowledges the current challenges in creating a reliable noninvasive device.

Consumers seeking accurate blood sugar measurements are advised to opt for FDA-cleared blood glucose monitors available at pharmacies. Dr. Klonoff emphasizes the importance of FDA approval, stating, “If the FDA approves it, the risk is very small. If you use a product not cleared by the FDA, very often the risk is very large.”

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Asif Iqbal

Asif Iqbal is a seasoned news writer with a passion for delivering the latest updates to the public. Currently serving as the senior writer at VoM News, a prominent news outlet known for its comprehensive coverage of diverse topics, Asif has established himself as a reliable source of information. With a keen eye for detail and a knack for storytelling, he consistently provides readers with well-crafted articles that cover a wide range of news categories. His dedication to journalistic integrity and his commitment to staying ahead of the news curve make him an invaluable asset to Vom News, ensuring that readers are always well-informed on the issues that matter most. You can find his work and stay updated on current events by visiting vomnews.in.