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The U.S. FDA warns that at present, those with Diabetes should not use a Smartwatch or Smart Ring to monitor Blood Glucose

1 cover Samsung Ring

On January 22, Patently Apple posted a report titled "Samsung Electronics Co. is exploring the development of noninvasive glucose monitoring and continuous blood pressure checking, setting its sights on ambitious health-care goals in a race with Apple Inc. and other tech giants. The work is part of a broader push to put health features in a range of devices, including its just-announced Galaxy Ring, said Samsung executive Hon Pak, who is overseeing the effort.

A year ago, Patently Apple posted a report titled "Apple has been working on a Blood Glucose Solution for Apple Watch since 2015 and a new rumor claims that Apple is closer to a Breakthrough." The report noted that "Apple's solution is based on silicon photonics."

In the long term Apple and Samsung wearables may one day prove valuable for those with diabetes with silicon photonics technology. Yet in the short-term, the FDA has made it crystal clear in a press release today that no current smartwatch, smart ring or other non-evasive device monitors glucose accurately or safely. A part of that press release is presented below.

Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication

Today the U.S. Food and Drug Administration (FDA) is warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin. These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGMs). The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.

For people with diabetes, inaccurate blood glucose measurements can lead to errors in diabetes management, including taking the wrong dose of insulin, sulfonylureas, or other medications that can rapidly lower blood glucose. Taking too much of these medications can quickly lead to dangerously low glucose, leading to mental confusion, coma, or death within hours of the error.

Recommendations for Consumers, Patients, and Caregivers

  • Do not buy or use smartwatches or smart rings that claim to measure blood glucose levels. These devices may be sold through online marketplaces or directly from the seller.
  • Be aware that the safety and effectiveness of these devices have not been reviewed by FDA, and the use of these devices could result in inaccurate measurements of blood glucose levels.
  • If your medical care depends on accurate blood glucose measurements, talk to your health care provider about an appropriate FDA-authorized device for your needs.

 

For more on this, read the full FDA report here. The report was first noticed by MacRumors.

While not as fashionable, Samsung has filed for a patent for a glucose testing device that uses micro needles. Until non-evasive technology can get approval from the FDA, Samsung's alternative system may be found appealing to some diabetics whenever it comes to market – or if comes to market.

Bloomberg's Mark Gurman reported on this matter back on February 22, 2023 in a report titled "Apple Makes Major Progress on No-Prick Blood Glucose Tracking for Its Watch." A Bloomberg TV interview with Gurman on that report is presented below.

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