FDA approves Signos glucose monitoring for weight reduction

The Food and Drug Administration approved the first-ever glucose monitoring system specifically for weight management from the startup Signos, the corporate said Wednesday, establishing a brand new option for Americans to administer their weight. 

Current treatment options for managing weight – popular drugs like GLP-1s and surgical interventions – are typically limited to patients with obesity or a certain BMI. Obesity drugs equivalent to Novo Nordisk‘s Wegovy and Eli Lilly‘s Zepbound will also be difficult to access attributable to their high costs, limited U.S. insurance coverage and constrained supply.

But now, any patient should buy a Signos membership to access its system. It uses an AI platform and an off-the-shelf continuous glucose monitor, or CGM, from Dexcom to supply personalized, real-time data and lifestyle recommendations for weight management. 

“There may be now an answer that everyone can use to assistance on the load loss journey, and also you do not have to be a certain variety of kilos to make use of it. It’s available for the typical American who needs it,” said Sharam Fouladgar-Mercer, Signos’ co-founder and CEO, in an interview on Tuesday ahead of the approval. “The typical person might need five kilos to lose, or others might need 100 kilos to lose. We’re here to assist them at any point in that journey.”

The obesity epidemic costs the U.S. health-care system greater than $170 billion a 12 months, in keeping with Centers for Disease Control and Prevention data. Almost 74% of Americans are chubby or obese, government data says. Signos hopes it might make a “real big dent in that curve for the betterment of lots of us,” Fouladgar-Mercer said. 

Customers who join for Signos can select a three-month or six-month plan, which currently costs $139 and $129, respectively. The corporate will ship out all the CGMs a patient needs for the variety of months within the plan they select.  

Insurers currently don’t cover the system for weight management, however the plans are a fraction of the roughly $1,000 monthly price of GLP-1s within the U.S. Signos is working with medical health insurance corporations and employers to get coverage for the system, the corporate said in a press release to CNBC. Signos said it expects “this to evolve quickly as interest for tackling weight continued to expand.”

The Signos system will be used together with GLP-1s or bariatric surgery, said Fouladgar-Mercer. He said patients also can use the system after getting off a GLP-1 to take care of their weight

CGMs are small sensors worn on the upper arm that track glucose levels, mainly for individuals with diabetes. That data is wirelessly sent to Signos’ app, which also allows patients to log their food intake and exercise levels, amongst other information that the AI platform uses to make recommendations. 

Other than helping people manage their weight, the system goals to assist users understand how their bodies reply to specific foods and exercise patterns and make the best behavioral changes to administer and maintain their weight in the long run. 

Signos didn’t share what number of patients are currently using its glucose monitoring system, but Fouladgar-Mercer said tens of hundreds of individuals have already tried it over time. He said Signos has scaled up its CGM inventory and software capability to “handle a reasonably massive scale” following the approval.