A new continuous glucose monitoring approach is making its debut over-the-counter—one that’s aimed not specifically at people with diabetes, but at users looking to guide their weight loss with personal data.
According to the developer Signos, the green light marks a new first from the FDA in weight management. Its system employs the Stelo CGM sensor from Dexcom—which received its own OTC clearance from the agency last year, with a nod to the wellness market—and pairs it with Signos’ smartphone app to help track how food choices, activity, stress and sleep can all affect metabolism.
“Everyone deserves access to insights that help them live healthier, longer, more vibrant lives,” Signos founder and CEO Sharam Fouladgar-Mercer said in a statement. “Signos isn’t just about data; it’s about giving people ownership over their health and weight journeys in a way never before seen.”
The company’s platform aims to translate the ups and downs of glucose levels into recommendations for daily habits and lifestyle changes. Signos also works in partnership with the digital nutrition counseling startup Nourish. It currently offers a quarterly subscription plan, including six CGM sensors, for $139 per month. Users are not intended to take any medical actions based on the app’s output without consulting a physician.
Designed as a more health-focused version of its flagship G7 sensor, Dexcom launched the 15-day Stelo in August 2024, describing it as made for adults who are not taking any insulin therapies—which includes about 25 million people with type 2 diabetes in the U.S., as well as any person looking to better understand the impacts of diet and exercise.
The over-the-counter CGM market also counts Abbott’s Lingo, a slimmed-down, wellness-focused version of its FreeStyle Libre line of sensors. It obtained an FDA clearance last year alongside the company’s Libre Rio, which is aimed at people with type 2 diabetes who are not taking insulin.
As GLP-1 medications for weight loss have taken center stage in the past few years, devicemakers have been looking to make the case for the benefits of their technologies.
Abbott said that its real-world analyses of FreeStyle Libre users with type 2 diabetes, who are also taking GLP-1s, showed that adherence to each approach increased when people used both. According to the company, CGMs provide “a level of accountability that drives higher therapy compliance and more durable outcomes.”
Dexcom, meanwhile, put out global survey results earlier this year showing that healthcare providers view technology and education as having larger impacts when it comes to treating type 2 diabetes, and ranked them higher than prescribing new medications.
Meanwhile, in the U.S., FDA Commissioner Martin Makary told senators during his confirmation hearing earlier this year that he sees CGMs and other home diagnostics as having the potential to ward off chronic diseases such as obesity and diabetes.
“Why are we requiring continuous glucose monitors to have a doctor’s prescription, when it’s good for people to use these monitors and learn about what they’re eating?” Makary said in March. “We don’t want to limit continuous glucose monitoring to people with diabetes; we want to prevent diabetes, when 30% of our nation’s children have diabetes or prediabetes, or some form of early insulin resistance.”
Department of Health and Human Services Secretary Robert F. Kennedy Jr. has also stated support for wearables, saying he’d like to see one on every American within the next four years.