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Stelo, made by the company Dexcom, is a small sensor worn on the upper arm that sends glucose data directly to users' smartphones.
The FDA stated the device is not designed to alert people with low blood sugar about dangerous levels.
Dexcom said the device is meant for adults over 18 years old who do not use insulin.
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That includes people with or without diabetes who want to better understand how diet and exercise impact their blood sugar levels.
The company said there are about 25 million people in the U.S. with Type 2 diabetes who do not use insulin and will benefit from having access to blood sugar monitoring devices.
Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, stated in a press release, "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 U.S. patients."
Stelo is set to be available in summer of 2024.