FDA Approves Dexcom's Stelo As First Glucose Monitoring Device Without Prescription

Tuesday, the FDA approved DexCom Inc’s DXCM Stelo Glucose Biosensor System as the first over-the-counter (OTC) continuous glucose monitor (CGM). 

The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin.

The company said Stelo will be available online without a prescription starting summer of 2024.

This system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. 

The Stelo Glucose Biosensor System uses a wearable sensor paired with an application installed on a user’s smartphone or other smart device to continuously measure, record, analyze, and display glucose values. 

Also Read: Continuous Glucose Monitor Maker Dexcom’s Q4 Profit Triples On Volume Growth And New Customer Additions.

Users can wear each sensor for up to 15 days before replacing it with a new sensor. The device presents blood glucose measurements and trends every 15 minutes in the accompanying app. 

Data from a clinical study provided to the FDA showed that the device performed similarly to other iCGMs. 

Adverse events reported in the study included local infection, skin irritation, and pain or discomfort.

The company says there are approximately 25 million people in the U.S. living with Type 2 diabetes who do not use insulin and who can benefit from continuous glucose monitoring technology. 

Dexcom G7 is available with a prescription. Stelo cleared for use without a prescription, will make it even easier for this population to access leading CGM technology and will provide an option for those who do not have insurance coverage for CGM.

Price Action: DXCM shares are trading higher by 2.64% at $125.50 premarket on the last check Wednesday.

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