San Diego device maker Dexcom has received the first FDA clearance for a continuous glucose monitor that doesn’t require a doctor’s prescription.
The U.S. Food and Drug istration cleared Dexcom’s Stelo biosensor for over-the-counter use on Tuesday. This opens the door for people to access a continuous glucose monitor without insurance coverage.
It is geared toward people who are 18 years and older who are not on insulin and who do not have problematic hypoglycemia. The device can be worn for up to 15 days before needing to be replaced.
The Stelo biosensor is a wearable device that fits in the palm of your hand and connects to a smartphone application. It constantly measures, records and analyzes the ’s glucose levels and then presents those results in the app every 15 minutes.
The use of its continuous glucose monitors on its own or alongside other diabetes or weight management tools can help people understand how different foods or activities affect their glucose levels, the company said in its announcement.
“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 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.”
The Centers for Disease Control and Prevention said in its latest report that as of 2021 roughly 29.7 million people in the United States are diagnosed with diabetes.
People diagnosed with Type 2 diabetes are unable to produce sufficient levels of insulin — a hormone that regulates the body’s energy supply — or they become insulin resistant. Depending on the severity of the condition, patients can manage Type 2 diabetes with diet management, exercise, oral medications or insulin injections.
With this clearance, there’s an opportunity in this growing market as more people learn about metabolic health and disorders, writes William Blair analyst Margaret Kaczor Andrew in a research note. The research firm estimates that there are millions more Type 2 non-insulin s domestically — about 25 million versus the roughly 7.5 million insulin-using diabetics — “meanwhile, the number of prediabetics is roughly triple the total number of Type 2 diabetics in the United States.”
“The details of the approval should not only raise demand but also point to a strong competitive moat for years to come,” she writes in the research note. “This is also the first time DexCom has offered a 15-day wear time, which should become the standard for its portfolio over time.”
Based on how these kinds of continuous glucose monitors get approved by the FDA, Kaczor Andrew writes that Dexcom’s only likely competitor in the near future is medical device maker, Abbott.
San Diego company’s new wearable device will help diabetics eat right, lose weightSince its founding in 1999, Dexcom has been a leader in developing and manufacturing continuous glucose monitors, which are vital for people managing diabetes. The San Diego-based company has global operations in Europe and parts of Asia.
Dexcom did not disclose the price for the Stelo biosensor. The company said the device “will be available for purchase online without a prescription at a competitive price starting in summer 2024” and the price will be released once it launches.
The company initially announced its plans for a new wearable device that caters to people not taking insulin during an investor presentation last year.
