Experts Just Approved the First Over-the-Counter Wearable Blood Sugar Monitor

If you’re pre-diabetic, want to balance your physical activity against your diet, or you’re just uber-curious to know how what you eat affects your blood sugar, today there’s thrilling news: The Food and Drug Administration (FDA) has just approved the nation’s first-ever continuous glucose monitor (often also called “CGMs”).

Before the continuous glucose monitor, people living with diabetes had to subject themselves to daily finger pricks with a lancet to test their blood sugar. A drop of blood was added to a testing stick and then put into a glucose monitor, providing a blood sugar reading. Besides the pain, this took planning around meals and routines and can’t always provide a clear explanation for blood sugar swings. Plus, there are far more Americans than the roughly 40 million with diabetes who could benefit from this intel.

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A little history: A team of endocrinology experts have reported that the FDA approved the first continuous glucose monitor in 1999. Since then, innovations and technological updates have transformed it into a sleek patch-like item placed on one’s upper arm. Many wearable CGMs also pair with a smartphone to scan for blood sugar readings throughout the day. This can help enlighten the wearer on how food, physical activity, sleep and other factors impact their own unique blood sugar levels.

Until 2024, to obtain a continuous glucose monitor, a person would have to consult a healthcare provider and get a prescription. However, the FDA announced on March 05, 2024 that it had approved the first over-the-counter CGM, opening up the use of this versatile tool to Americans without requiring a prescription.

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DexCom is the manufacturer specializing in glucose monitoring products that developed this over-the-counter device, which is called the Stelo Glucose Biosensor System. The Stelo is worn on the upper arm and pairs with a smartphone app. It is designed to measure and analyze glucose readings to give the wearer a clearer picture of their blood glucose levels. According to a DexCom news release, it will display measurements and trends every 15 minutes. Each sensor is designed to be worn for 15 days before needing replacement. It will be available sometime in the summer of 2024, and the price has yet not been reported.

Stelo opens up glucose monitoring to people 18 and older with type 2 diabetes, as well as to those who do not have the condition but want a clearer picture of how diet or exercise affects their blood sugar. Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health said in the FDA’s release that “giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for US patients,” he added.

A warning from the FDA: The device does not come without caveats. The Stelo CGM is not designed for people with hypoglycemia issues and it won’t alert the user to the condition.

The manufacturer adds a warning that people should not make decisions based solely on the information received from Stelo without first consulting a healthcare provider—as just one example, to stop or increase certain medications. It also stipulates that a blood glucose monitor should be used as a backup if the individual symptoms and readings don’t seem to be in sync.

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