The U.S. Food and Drug Administration has approved the first over-the-counter continuous glucose monitor.
The Dexcom Stelo Glucose Biosensor System will be available by summer for people with prediabetes or Type 2 diabetes who are not using insulin to manage their condition.
How It Works
The Dexcom system is intended for people aged 18 and older who rely on oral medication to treat their diabetes and are looking for more information on how diet and exercise impact blood sugar levels. However, the FDA said that the system is not designed for people with problematic hypoglycemia, which is low blood sugar, as it does not alert users to this potentially dangerous condition.
These monitors “can be a powerful tool to help monitor blood glucose,” Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said 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.”
Patients wear the Stelo Glucose Biosensor System on the back of their upper arm. The sensor connects to a smartphone app or other smart device, continuously measuring, recording, analyzing, and displaying glucose levels. Users must change the sensors every 15 days.
FDA Clears Biosensor, Citing Promising Clinical Data
The device performed similarly to other continuous glucose monitors, also known as CGMs, in clinical studies, according to the FDA. Dexcom added that studies on the use of the device were associated with improvements in quality of life, time in the target glucose range, and A1C (glycated hemoglobin) levels—all vital readings that help maintain healthy blood glucose levels.
Potential adverse effects of wearing the sensor include infection at the sensor site, skin irritation, and some pain or discomfort.
While the sensor is designed to help people understand how lifestyle choices like diet and exercise affect their glucose levels, the system is not intended to provide sufficient information for people to take medical action without consulting a health care provider, the FDA noted.
Diabetes Cases Continue to Rise
An estimated 38.4 million people in the U.S. live with diabetes, accounting for just over 11 percent of the American population, according to the National Institute of Diabetes and Digestive and Kidney Diseases. Almost one in four adults living with diabetes were undiagnosed.
Millions of people are prediabetic. In 2021, an additional 97.6 million Americans aged 18 and older had prediabetes, according to the American Diabetes Association.
Moreover, the number of cases continues to rise, with 1.2 million more Americans being diagnosed every year.
Roughly 25 million people living with type 2 diabetes don’t use insulin to treat their disease, according to Dexcom.
“For people newly diagnosed with Type 2 diabetes or not taking insulin, these devices are often not covered by insurance and Stelo presents an opportunity to provide valuable information that can impact their diabetes management,” Dr. Tamara Oser, founder and director of Primary Care Diabetes Lab, said in a Dexcom press release.
While the price for the new Stelo system has not been announced, the company touts it as a less expensive option compared to current prescription-based glucose monitors, which can range from under $100 up to $300 per month, depending on insurance benefits.