The small, wearable Dexcom Stelo Glucose Biosensor System is an integrated CGM intended for patients aged 18 years and older and is designed to be worn on the back of the upper arm
DexCom gets FDA clearance for Stelo CGM. (Credit: Business Wire)
DexCom has received the US Food and Drug Administration (FDA) marketing clearance for the Stelo continuous glucose monitor (CGM) for people with diabetes.
The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for patients aged 18 years and older. The small, wearable sensor is designed to be worn on the back of the upper arm.
It is intended for patients who do not use insulin, like diabetes individuals treating their condition with oral drugs, or those without diabetes who seek more information on the effect of diet and exercise on blood sugar levels.
Stelo is now the first over-the-counter (OTC) glucose biosensor that doesn’t require a prescription, the company said.
The CGM continuously measures, records, analyses, and displays glucose values in individuals 18 years of age and older who are not on insulin and do not have problematic hypoglycemia.
It pairs a wearable sensor with an application that is installed on a user’s smartphone or other smart device. The users may wear each one for up to 15 days before switching out a sensor for a new one.
Through the accompanying app, Stelo displays blood glucose readings and trends every fifteen minutes.
Dexcom EVP and chief operating officer Jake Leach said: “Dexcom continues to lead innovation in the CGM market, with a long list of first-in-market advances.
“Dexcom was the first to connect CGM to multiple insulin delivery devices, the first to connect CGM to a smartphone, the first to replace fingersticks for treatment decisions, and now is creating a new category by bringing the first glucose biosensor cleared for use over-the-counter.
“Based on our experience serving people with Type 2 diabetes not using insulin, we have developed Stelo with their unique needs in mind.”
The FDA received data from clinical studies demonstrating that the device’s performance was comparable to that of other iCGMs.
The trial’s adverse events included pain or discomfort, skin irritation, and local infection.
Stelo is expected to be sold online without a prescription from starting this summer.