The U.S. Food and Drug Administration (FDA) has issued a warning to Americans: “Don’t use smartwatches or smart rings to measure blood glucose levels.”

Many individuals within the diabetes community have undoubtedly been tempted by noninvasive blood sugar meters and monitors in the shape of rings and watches, which might easily be found at Amazon and other online vendors. A noninvasive glucose monitor is a tool that may measure blood sugar levels without piercing the skin. They promise a needle-free experience and will cost far lower than leading continuous glucose monitor (CGM) systems.

However the FDA wants consumers to know that none of those products have ever been evaluated for accuracy by authorities: “The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is meant to measure or estimate blood glucose values by itself.”

Glucose-monitoring watches or rings, in other words, can’t be trusted. The manufacturers of the available models haven’t bothered to submit their devices for FDA testing. These devices aren’t medical equipment, and the glucose values they report ought to be considered inaccurate (if not fictional). The FDA is emphasizing that they need to absolutely not be used for diabetes management decisions.

While inaccurate blood sugar values could also be relatively harmless for people without diabetes, they could be extraordinarily dangerous to individuals who use insulin, sulfonylureas, or some other medication that carries a risk of hypoglycemia (low blood sugar). Basing a treatment decision (for instance, the choice to manage insulin to bring a high blood sugar level down) on an inaccurate measurement could possibly be disastrous.

Will We Ever Have Approved Noninvasive Glucose Monitors?

A reliable noninvasive glucose monitor is routinely described as certainly one of the holy grails of diabetes tech.

For years, the diabetes community has been delighted by rumors that firms similar to Apple, Google, and Samsung were adding glucose measurement to their smartwatches or developing stand-alone glucose monitoring devices.

A few decade ago, Apple CEO Tim Cook explained that the tech giant had little interest in registering its signature watch as a real medical device, but left the door open regarding a specialized product: “We don’t wish to put the watch through the FDA process. I wouldn’t mind putting something adjoining to the watch through it, but not the watch because it might hold us back from innovating an excessive amount of, the cycles are too long.”

The rumors are still swirling, but as yet none of those tech giants have released a product able to blood sugar measuring. The Oura Smart Ring, a trendsetting biohacking device, cannot measure blood sugar either, though it will possibly integrate CGM data into its reporting.

It’s not only the massive guys racing to develop a noninvasive CGM. We recently profiled Know Labs, a startup that intends to submit its latest prototype for full FDA approval. If successful, there could possibly be a noninvasive CGM available on the market as early as the top of 2025.

As of this writing, the noninvasive glucose meters and monitors available for purchase in the US appear to mostly come from smaller and more obscure businesses — ones which might be presumably less able to (and dedicated to) quality engineering. The FDA states: “These smartwatches and smart rings are manufactured by dozens of firms and sold under multiple brand names.”