The U.S. Meals and Drug Administration (FDA) has cleared the primary steady glucose displays (CGMs) for over-the-counter sale—a significant win for well being freedom and customary sense.
“Giving extra people worthwhile details about their well being, no matter their entry to a physician or medical insurance, is a crucial step ahead in advancing well being fairness for U.S. sufferers,” mentioned Jeff Shuren, director of the FDA’s Heart for Gadgets and Radiological Well being, in a press launch asserting the change.
CGMs are wearable gadgets that repeatedly monitor blood sugar ranges in actual time. They have been invaluable for diabetics—however their potential goes a lot additional. As an illustration, these with chronically elevated blood sugar ranges, even when they do not meet the edge for diabetes, might use CGMs to handle their well being early and keep away from a future prognosis.
Even in metabolically wholesome people, avoiding blood sugar spikes and crashes can help weight reduction, regular vitality ranges, and general well-being since elevated blood sugar could cause oxidative stress and irritation.
Earlier than CGMs, the easiest way to check blood sugar ranges at dwelling was by pricking a finger and utilizing a glucose check strip. I used this technique after I was recognized with gestational diabetes a couple of years again. It was disagreeable, inconvenient—requiring lancets, check strips, and a reader—and really restricted in insights, because it might solely measure blood sugar ranges at one discrete cut-off date. If my blood sugar rapidly spiked past regular ranges but in addition rapidly fell, pricking my finger an hour or two after consuming, as advisable, would fail to seize this.
CGMs supply a extra handy approach of gleaning details about blood sugar responses, which may fluctuate vastly between individuals and even inside the identical particular person relying on totally different variables. (Whereas carbohydrates are understood to spike glucose ranges larger than proteins and fat do, particular person our bodies can nonetheless react very in a different way to meals.)
Till this yr, Individuals wanted a prescription for CGMs, which have been formally authorised just for use by diabetics. That meant anybody who merely wished to study their very own blood sugar responses both was out of luck or needed to discover a physician or program keen to jot down an off-label prescription.
As curiosity in CGMs for nondiabetics grew, firms reminiscent of Ranges, Signos, and ZOE emerged to cater to the market.
I signed up with Signos after studying that the “gestational diabetes” I had been recognized with was truly an ongoing challenge with insulin manufacturing. Utilizing the CGM that Signos offered (Dexcom’s G7 sensor) was much less annoying and extra informative than the finger prick technique had been. However getting a CGM via Signos was not as easy—or reasonably priced—as shopping for over-the-counter, because it nonetheless required a web-based session and a Signos physician’s approval. And with the Signos program—which got here with an app, neighborhood teams, weight reduction monitoring instruments, and challenges and exams for customers—I used to be paying for lots of bells and whistles I actually did not want.
For these wanting further help, Signos and the like could also be nice. And it is value appreciating firms innovating in a closely regulated area. However I grew more and more aggravated that I could not merely go right into a drugstore and purchase a CGM.
Fortunately, in March 2024, the FDA cleared Dexcom to market and granted it the authorized energy to promote the Stelo Glucose Biosensor System on to customers. It is indicated for diabetics not utilizing insulin and “these with out diabetes who need to higher perceive how food regimen and train might affect blood sugar ranges,” per the FDA. Abbott has additionally obtained FDA clearance to launch two over-the-counter CGMs, one (the Libre Rio) for Kind 2 diabetics who do not use insulin and one (the Lingo) for individuals with out diabetes.
After having discontinued my CGM use for greater than a yr, I made a decision to present the Stelo a attempt. Getting it was easy—I simply went on the Stelo web site, added it to my cart, and checked out like I might with some other product. Plus, it was simpler on my pocketbook.
The Signos CGM prices $449 a month, or $199 a month with a subscription. Stelo’s, however, is simply $99 a month or $89 a month with a subscription. And you will get a single Lingo biosensor (lasting two weeks) for $49 or a 12-week provide for $249. We will anticipate CGM costs to go even decrease as extra over-the-counter variations are authorised.
How helpful CGMs are for nondiabetics is a matter nonetheless hotly debated in science and wellness communities. However a CGM is solely a tool that displays a well being metric. By limiting CGMs to prescriptions and diabetics, the FDA wasn’t defending customers—it was holding them at nighttime.
