FDA: don’t use smartwatches to measure blood glucose levels

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 hasn’t authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.

The FDA says that, 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.

Here are the FDA’s 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.

Apple is rumored to be working on a version of the Apple Watch that can measure blood glucose non-invasively. In a March 23, 2023, Power On” newsletter, Bloomberg’s Mark Gurman said the Apple Watch likely won’t get blood glucose monitoring features for another 3-7 years.

Why? Apple “still needs to perfect the algorithms and on-board sensors” to bring the technology to market. And the tech giant also needs to “shrink it down to the size of a module that can fit in the small and thin package that is an Apple Watch.”

Gurman said the goal of Apple’s secret endeavor — dubbed E5 — is to measure how much glucose is in someone’s body without needing to prick the skin for blood. After hitting major milestones recently, the company now believes it could eventually bring glucose monitoring to market, he added.

This is a feature that’s been rumored for a years. In 2017, CNBC reported that Apple had a small team of biomedical engineers working on a secret initiative to develop non-invasive glucose sensors in what it hopes would be a game-changer for diabetes treatment, The effort — apparently under way for at least five years, and envisioned originally by co-founder Steve Jobs — hopes to be the first to track blood sugar levels accurately without piercing the skin. One source said the team is working on optical sensors that might shine a light through the skin for measurement.

Though the CBNC story concentrated on diabetes monitoring, optical sensors could also measure blood glucose levels. And Apple is increasingly positioning the Apple Watch as a health/fitness tool.

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