The FDA has approved the first over-the-counter continuous glucose monitoring (CGM) system. It is intended for adults with or without blood sugar concerns who don’t use insulin.
The Dexcom Stelo Glucose Biosensor System can help people with blood sugar concerns who take medication know their blood sugar at all times. It could help people without blood sugar concerns learn how diet and exercise impact their blood sugar. It is not intended for people with low blood sugar.
The system links to a smartphone app. It measures and records blood sugar every 15 minutes and is worn for 15 days before being replaced. It will be available in stores this summer, but the price hasn’t been announced.
“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 healthcare provider,” said Dr. 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.”
“Use of CGM can help empower people with [blood sugar concerns] to understand the impact of different foods and activity on their glucose values,” said Dr. Tamara Oser, Family Physician. She added, “these devices are often not covered by insurance and Stelo presents an opportunity to provide valuable information.”
Dexcom, the company behind Stelo, stresses that it doesn’t replace doctors. People shouldn’t make changes to their medications to medical routines based on the sensor’s readings. Instead, it should be a tool to understand their blood sugar better so that they are better informed and can make decisions with their doctor based on more accurate personal information. It can also help a person tweak their diet and exercise routine. It is not designed to alert people to dangerous situations, just daily fluctuations.
It performs similarly to other integrated CGMs. The difference is that it’s available OTC. In a clinical study, the side effects were the same as those of other integrated CGMs: skin irritation, infections at the site of the monitor, discomfort and pain.
We’ll learn the price of the monitor this summer. Hopefully, this OTC monitor will help more people gain access to information about their blood sugar health. It will empower people to make better health decisions and have better insights into how their actions impact their bodies.
