FDA green lights first over-the-counter continuous blood glucose monitor

You can soon buy an over-the-counter continuous glucose monitor
Posted at 3:04 PM, Mar 06, 2024

(WXYZ) — The FDA has cleared the first continuous blood glucose monitor available without a prescription. The device, named Stelo, is designed for people with Type 2 diabetes who do not use insulin. 

I've got family and patients dealing with diabetes, so I'm well-acquainted with continuous glucose monitors, or CGMs for short. These wearable devices make life much easier for diabetics. Instead of many finger pricks, the device measure blood sugar levels using small sensors that poke through the skin.

Now, Stelo was designed for people with type 2 diabetes who are 18 and over and who don’t use insulin. Most people think of insulin as the only way to treat diabetes, but for type 2, some people can manage it with oral medications, non-insulin injectable medications, or by eating healthy and exercising.

So, how does the Stelo work? Well, it’s a small sensor that is worn on the back of the upper arm. It helps to detect normal and low or high glucose levels. You can wear it for up to 15 days, then swap it for a new one. Glucose levels are tracked 24 hours a day, and measurements are given every 15 minutes. The data gets sent directly to a smartphone, which can alert users, their families, and doctors about fluctuations in blood sugar levels. It’s important to know that people with problematic hypoglycemia should not use Stelo. Hypoglycemia is low blood sugar, which can be quite dangerous.

The FDA noted that local infection, skin irritation, and pain or discomfort were reported in a clinical study. Local infection means that just one body part or organ is affected, not the entire body. This is something diabetes patients need to be aware of because they have an increased risk of infection. So if there’s redness, swelling, or pain at the insertion site, it’s best to see a doctor.

As for when it’ll be available, Dexcom, the company behind Stelco, says you’ll be able to buy online starting this summer. They haven't said how much it'll cost yet.

I like that Stelo doesn't need a prescription. That means more people, especially those without insurance, can get it. It can help people see how food and activity affect glucose levels, even if you don’t have type 2 diabetes. I also want to stress that it’s important to know proper skin care and common signs of skin infections. And not to make changes to any medications based on the sensor data without first talking to your healthcare provider.