The FDA recently announced its clearance for the first-ever over-the-counter continuous glucose monitor (CGM) for commercial sales.

The Dexcom Stelo Glucose Biosensor System is commercially available without a prescription. However, the device is intended for adults who do not use insulin but still need to monitor their HbA1c, a group that includes 1) patients with diabetes who use oral medication and 2) people who do not have diabetes but want to monitor changes in their blood glucose levels. The FDA specified that the device was not designed to alert users of problematic hypoglycemia and is not intended for people with this condition.

“CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the announcement. “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.”

The Stelo Glucose Biosensor System consists of a wearable sensor and paired app. The sensor can be used for up to 15 days before it needs to be replaced, and together, the sensor and app offer users updates on changes and trends in their blood glucose levels every 15 minutes.

According to the FDA’s press release, Dexcom has provided the agency with data from a clinical trial with results indicating that the Stelo Glucose Biosensor System performs similarly to other continuous glucose monitoring systems. The most common adverse events were skin irritation, pain or discomfort, and local infection, the FDA said.

The Dexcom Stelo Glucose Biosensor System is indicated for people aged 18 years and older who do not use insulin. The FDA’s clearance comes with a caution that users should not make medical decisions based on information the sensor provides without guidance from a medical professional.

Dexcom’s website says that the device will be available to consumers starting this summer.

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Disclosures: MD/alert could not confirm financial disclosures for Shuren at the time of reporting.