FDA gives green light to first over-the-counter continuous glucose monitor

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

I have family members and patients with diabetes, so I am familiar with continuous glucose monitors (CGMs for short). These wearable devices make life a lot easier for people with diabetes. The device uses a small sensor that pierces the skin to measure blood sugar levels instead of multiple finger pricks.

Currently, Stelo is designed for people with type 2 diabetes who are 18 years of age or older and do not use insulin. Most people think insulin is the only way to treat diabetes, but some people with type 2 can manage it with oral medications, injectable medications other than insulin, or with a healthy diet and exercise .

So how does Stelo work? Well, it’s a small sensor that you wear on the back of your upper arm. Helps detect normal blood sugar levels and low or high blood sugar levels. You can wear it for up to 15 days, then replace it with a new one. Blood sugar levels are tracked 24 hours a day, with measurements taken every 15 minutes. The data is sent directly to the smartphone and can alert users, their families, and doctors about fluctuations in blood sugar levels. It is important to know that a person with problematic hypoglycemia should not use Stelo. Hypoglycemia is a condition where blood sugar levels are low and can be very dangerous.

The FDA noted that local infections, skin irritation, pain and discomfort have been reported in clinical studies. A local infection means that only one part or organ of the body is affected, rather than the entire body. This is something to be aware of as diabetics are at higher risk of infection. Therefore, it is best to see a doctor if you experience redness, swelling, or pain at the insertion site.

As for when it will go on sale, Dexcom, which operates Stelco, says it will be available for purchase online starting this summer. They haven’t yet said how long it will take.

I love that Stelo doesn’t require a prescription. That means more people, especially the uninsured, can get this coverage. Even if you don’t have type 2 diabetes, it can help you understand how your diet and activity affect your blood sugar levels. I would also like to emphasize the importance of proper skin care and knowing the common signs of skin infections. Also, do not change your medications based on sensor data without first consulting your healthcare provider.