A new over-the-counter product cleared by the FDA combines a continuous glucose monitor (CGM) with an artificial intelligence (AI)-based app to assist users in weight management.

The Signos Glucose Monitoring System was cleared by the FDA on March 21, 2025, and announced by the company on August 20, 2025. The system receives data from an integrated CGM (Dexcom Stelo) that measures, records, analyzes, and displays glucose data values. It is intended for people aged 18 years or older who are not using insulin. The platform can be synched with Apple Health, Google Health Connect, smartwatches, and smart scales.

According to the FDA, in addition to detecting high, low, and normal glucose values, the Signos system “may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursions. This information may be useful in helping users maintain a healthy weight. The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional.” 

Signos offers two subscription options, a 3-month plan for $139 per month and a 6-month plan for $129 per month. Subscriptions include two Stelo biosensors per month, along with the app, metabolic weight management program, and setup instructions. The system is not currently covered by insurance, but some subscribers may be able to use health savings account or flexible spending account funds for reimbursement.

Endocrinologist and Signos Consultant Jay M. Skyler, MD, told Medscape Medical News that the product is “an AI-based behavioral modification tool that collects all sorts of data points from logged meals, workouts, weight, and glucose. When something you eat spikes your glucose, the app suggests the right type and intensity of movement based on the individual’s history to help get the glucose back down again.”

In people without diabetes, minimizing blood glucose spikes may also reduce excess insulin secretion that promotes fat storage, although it’s impossible to tease out that effect from the behavioral aspect. “The app integrates millions of data points, so it's a component of that. But you can’t really break it down to how much each component is contributing. It's all integrated in the app,” Skyler said.

Skyler, who is the Deputy Director of the Diabetes Research Institute at the University of Miami, Coral Gables, Florida, noted that this is the first such system to undergo clinical trials to obtain FDA clearance. However, those data are not yet published and the company declined to share them with Medscape Medical News at this time. Only one trial has been published using the system, for which Sklyer was an author.

Part of a Larger Weight Management Strategy

Asked to comment, Katherine H. Saunders, MD, chair of The Obesity Society’s Communications Committee and co-founder of the medical weight loss program FlyteHealth, told Medscape Medical News, “For individuals with obesity, I wouldn’t view a behavioral program plus CGM as a standalone solution as most people require comprehensive, long-term medical treatment. But it could certainly be a helpful part of a care plan.”

Added Saunders, also an obesity medicine specialist at Weill Cornell Medicine, New York City, “If a behavioral program plus CGM helps individuals understand how different foods affect their blood glucose andmake sustainable dietary changes, I’m all for it. However, if people stop using the system and return to their previous eating habits, it might not be the best option for them. I’m curious to see long-term data.”

Also asked to comment, Obesity Expert Amy E. Rothberg, MD, clinical professor of internal medicine and of nutritional sciences at the University of Michigan, Ann Arbor, Michigan, told Medscape Medical News, “Many devices have shown some desirable outcome at 6 months, but with anything novel, people stop finding the novelty after a period of time. I’m sure there are a group of individuals for whom this would make a difference but not sure it’s going to solve obesity.”

Rothberg also pointed out that one optional feature of the Signos system, the ability to chat with a dietitian in-app or book a face-to-face appointment for personalized guidance, may be more impactful than the CGM.

“It would be useful to know who uses what and how that translates to outcomes. Obviously, the more engaged, the more likely one is to do well. If I were the company, I would analyze the user base in terms of its other offerings on the platform and see what of the various other things are most used and how frequently they are accessed. Tracking glucose in someone with normal glucose may be a curiosity for a short-term but I just can’t fathom that it alone would make any difference in an individual’s behavior in the long-term.”

Skyler, who is professor of medicine, pediatrics and psychology at University of Miami, said that the Signos system could be combined with other weight management approaches, including GLP-1 medications or bariatric surgery. “There have been studies showing that use of CGM together with a GLP-1 does better than a GLP-1 alone in terms of weight loss. But here you’ve also got an app that’s guiding you.”

However, Skyler also said that for a person who has a BMI of 25-30 “I might initially try to just use the Signos system to see how they do.”

Skyler reported being a shareholder of Signos and Dexcom. Saunders and Rothberg had no disclosures.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X @MiriamETucker and BlueSky @miriametucker.bsky.social.