The Food and Drug Administration will allow DexCom to begin marketing its Stelo Glucose Biosensor System, the first over-the-counter continuous glucose monitor.
The continuous glucose monitor is intended for those with diabetes ages 18 and up who do not use insulin, including those with diabetes who use oral treatments. The continuous glucose monitor can also be used by those without diabetes who "want to better understand how diet and exercise may impact blood sugar levels," the FDA said.
The FDA said the system is not intended for diabetics who use insulin, nor is the system designed to alert users to problematic hypoglycemia.
“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,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “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.”
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DexCom claims continuous glucose monitors are associated with "clinically meaningful improvement in time in range, A1c and quality of life." The company said it intends to have units available for the public this summer.
“Use of CGM can help empower people with diabetes to understand the impact of different foods and activity on their glucose values,” said Dr. Tamara Oser, director in the Department of Family Medicine at the University of Colorado School of Medicine. “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.”
The American Diabetes Association says continuous glucose monitors allow users to see in real-time if their blood sugar is trending too high or low and take preventative measures against hypo- and hyperglycemia.
The Centers for Disease Control and Prevention estimates that 38.4 million Americans, representing 11.6% of the population, have diabetes. Of those, 8.7 million have not been diagnosed. An additional 97.6 million Americans have prediabetes.
