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Beware of Unapproved Blood Glucose Monitoring Claims, FDA Advises Smartwatch Users

ByHuey Yee Ong

Feb 26, 2024
Beware of Unapproved Blood Glucose Monitoring Claims, FDA Advises Smartwatch Users

The U.S. Food and Drug Administration (FDA) has recently raised concerns over the increasing reliance on wearable technology, such as smartwatches and smart rings, which claim to monitor blood sugar levels without invasive measures. This advisory targets a growing market of health-conscious consumers and diabetic patients who may be misled by the capabilities of these devices. In its cautionary message, the FDA explicitly states that no wearable device has received approval for non-invasive blood glucose monitoring, urging the public to be vigilant and skeptical of such claims.

FDA’s Stance on Smartwatch Capabilities

Manufacturers of various wearable technologies have been marketing their products as capable of monitoring glucose levels without requiring the traditional method of drawing blood. These claims suggest a revolutionary step forward in non-invasive health monitoring, promising convenience and pain-free tracking for users, particularly appealing to those managing conditions such as diabetes. However, the FDA has made it clear that such capabilities have not yet been scientifically validated to the extent required for regulatory approval. The agency’s statement clarifies that all current methods of accurate blood glucose monitoring must involve some form of skin penetration, either through finger-pricking or other minimally invasive technologies.

The risk associated with relying on unapproved devices for glucose monitoring is significant, particularly for individuals managing diabetes. Here are the key concerns:

  • Inaccurate Glucose Measurement: Reliance on devices not approved by the FDA can lead to significant errors in blood sugar readings.
  • Health Repercussions:
    • Incorrect insulin administration or dosing of other glucose-lowering medications.
    • Rapid onset of hypoglycemia, a condition characterized by dangerously low blood sugar levels.
  • Symptoms of Severe Hypoglycemia:
    • Mental confusion and disorientation.
    • Loss of consciousness.
    • In extreme cases, death can occur within hours without proper intervention.

Are Major Tech Companies Closing in on Non-Invasive Glucose Monitoring?

Despite the absence of FDA-approved smart devices for non-invasive glucose monitoring, the pursuit of such technology remains a hot topic within the tech industry. Reports have circulated about major companies like Apple and Samsung exploring innovative approaches to glucose monitoring. Apple, for instance, has been rumored to be developing technology that would allow its Apple Watches to monitor glucose levels through a non-invasive optical sensor. This feature, aimed at non-diabetic individuals, would mark a significant advancement in wearable health technology, providing users with valuable health insights without the need for blood samples.

Similarly, Samsung has expressed its intention to incorporate non-invasive blood glucose monitoring into its Galaxy Watch line. In conversations with the media, Samsung’s leadership in mobile digital health has highlighted the competitive nature of the industry’s push towards developing such groundbreaking technologies. These endeavors signal a clear interest and investment in enhancing the capabilities of wearable devices to support health and wellness.

FDA’s Advice for Consumers and Healthcare Providers

In light of these developments, the FDA continues to support the use of smart devices in conjunction with approved glucose monitoring technologies. Devices that require skin penetration for glucose measurement, such as continuous glucose monitors (CGMs), are considered reliable and safe for use. The agency encourages healthcare providers to inform their patients about the limitations and risks of using unapproved devices for glucose monitoring.

To safeguard public health, the FDA urges consumers to report any issues related to inaccurate blood glucose measurements, adverse effects, or the use of unauthorized devices. The agency’s MedWatch Voluntary Reporting Form is available for such reports, playing a critical role in monitoring the safety and efficacy of health monitoring technologies available to consumers.

As the technology landscape continues to evolve, the FDA’s guidance serves as a reminder of the importance of regulatory oversight in ensuring the safety and reliability of health monitoring devices. While the prospect of non-invasive glucose monitoring is enticing, consumers are advised to rely on scientifically validated and FDA-approved methods for managing their health, especially for conditions as sensitive and critical as diabetes.


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Featured Image courtesy of Sarah Silbiger/Getty Images

Huey Yee Ong

Hello, from one tech geek to another. Not your beloved TechCrunch writer, but a writer with an avid interest in the fast-paced tech scenes and all the latest tech mojo. I bring with me a unique take towards tech with a honed applied psychology perspective to make tech news digestible. In other words, I deliver tech news that is easy to read.