Feb 22, 2024 10:32:00

Regarding the blood sugar level measurement function that Apple Watch also aims for, the regulatory agency FDA warns ``Do not use the non-invasive blood sugar level measurement function of smart watches''

It has long been

rumored that Apple is planning a blood sugar level measurement function as a new feature for the Apple Watch. However, the US regulatory authority, the US Food and Drug Administration (FDA), has expressed opposition to the ability to measure blood sugar levels using non-invasive methods such as smart watches.

Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose Levels: FDA Safety Communication | FDA
https://www.fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication

US FDA warns against using smartwatches to measure blood glucose | Reuters
https://www.reuters.com/business/healthcare-pharmaceuticals/fda-warns-consumers-over-use-smartwatches-measure-blood-glucose-levels-2024-02-21/

FDA stands against using smartwatches to monitor blood glucose
https://9to5mac.com/2024/02/21/fda-smartwatches-blood-glucose/

On February 21, 2024, the FDA issued a warning: 'Do not use smart watches or smart rings to measure blood sugar levels.' We explain that we do not approve or approve smart watches or smart rings that independently measure or estimate blood sugar levels. Please note that this does not include ``smartwatch applications that display data from FDA-approved blood glucose measurement terminals that are used by puncturing the skin, such as continuous glucose monitoring devices (CGMs).''

For people with diabetes, the FDA claims that inaccurate blood sugar readings can lead to mistaken ingestion of insulin, sulfonylureas, and other drugs meant to rapidly lower blood sugar. Taking too many of these drugs can quickly send patients into a dangerously low blood sugar state, which can accidentally lead to mental confusion, coma, or death within hours.

Therefore, FDA recommends the following three points for consumers, patients, and caregivers:

- Don't buy or use smart watches or smart rings that claim to measure blood sugar levels. These devices may be sold through online marketplaces or directly from sellers.
Please be aware that the safety and effectiveness of these devices has not been reviewed by the FDA, so using these devices may result in inaccurate blood sugar measurements.
-If your medical care depends on accurate blood glucose measurements, ask your healthcare provider about the appropriate FDA-cleared device for your needs.

In addition, the FDA made three recommendations for healthcare providers:

-Follow FDA recommendations for consumers, patients, and caregivers.
Discuss with patients the risks of using unapproved blood glucose monitoring devices.
-Assist patients in selecting appropriate FDA-approved blood glucose monitoring devices as needed.

Regarding the problematic smart watches and smart rings, the FDA says, 'The problematic devices claim to be able to measure blood sugar levels without pricking your finger or puncturing your skin. It does not directly measure blood sugar levels. These types of devices are manufactured by dozens of companies and sold under multiple brand names. Regardless of manufacturer or brand, safety communications can measure blood glucose levels without puncturing the skin. This applies to smart watches and smart rings that claim to measure .

The FDA regularly monitors the medical device market and is aware that unauthorized products are being sold to consumers. FDA is working to prevent manufacturers, distributors, and sellers from illegally selling unapproved smart watches and smart rings that purport to measure blood sugar levels. Additionally, the FDA is warning consumers about this issue and educating the public that smart watches and smart rings should not be used to measure blood sugar levels.

In addition, '

Dexcom G7 ' is listed as a CGM approved by the FDA for use in measuring blood sugar levels.

Apple has long been rumored to be developing technology to non-invasively measure blood sugar levels. Regarding the blood sugar level measurement function that Apple is developing, 9to5Mac says, ``Using a technology called silicon photonics, a laser is irradiated to the area under the skin where intestinal fluid containing substances that are absorbed by glucose is present, and the wavelength of light is used to detect blood glucose levels in the blood sugar level. 'We are experimenting with a process called ``optical absorption spectroscopy,'' which measures these values.''

9to5Mac also states that ``Apple is unlikely to provide blood sugar measurement functionality without FDA approval.''