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US FDA greenlights first glucose monitoring system for weight loss

In a significant development for weight management, the Food and Drug Administration (FDA) announced Wednesday its approval of the first-ever glucose monitoring system designed specifically for weight loss, developed by the startup Signos. 

This approval introduces a new tool for Americans seeking to manage their weight.

Current weight loss treatments, such as popular GLP-1 drugs and surgical procedures, are generally restricted to patients who are obese or have a specific BMI, according to a CNBC report.

Access to obesity medications like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound is challenging because of their high price, inadequate US insurance coverage, and limited availability.

Accessibility

However, Signos now offers a membership for patients to access its system, which combines an AI platform with a Dexcom continuous glucose monitor (CGM), according to the report. 

This system provides personalised, real-time data and lifestyle recommendations to assist with weight management.

“There is now a solution that everybody can use to help on the weight loss journey, and you don’t have to be a certain number of pounds to use it. It’s available for the average American who needs it,” Sharam Fouladgar-Mercer, Signos’ co-founder and CEO, told CNBC in an interview.

The average person might have five pounds to lose, or others might have 100 pounds to lose. We are here to help them at any point in that journey.

Obesity presents a significant challenge to the US healthcare system, incurring costs exceeding $170 billion annually, as reported by the Centers for Disease Control and Prevention. 

Membership process

Government data indicates that nearly 74% of Americans are either overweight or obese. Signos aims to substantially impact this trend, contributing to improved health for many.

Signos offers customers two membership options: a three-month plan for $139 and a six-month plan for $129. 

Upon plan selection, Signos dispatches the necessary Continuous Glucose Monitors (CGMs) to cover the chosen membership duration.

Currently, weight management systems like Signos are not covered by insurers. 

However, their cost is significantly lower than the approximate $1,000 monthly price of GLP-1s in the US Signos is actively engaging with health insurance companies and employers to secure coverage for its system. 

The company anticipates a rapid increase in coverage as the interest in weight management solutions continues to grow.

How the Signos system works

Fouladgar-Mercer stated that the Signos system is compatible with GLP-1s or bariatric surgery. He added that the system can also help patients sustain weight loss after discontinuing GLP-1 use.

Small sensors worn on the upper arm, CGMs primarily track glucose levels in individuals with diabetes, according to the report. 

The data is transmitted wirelessly to the Signos app, which integrates with an AI platform. This platform uses the glucose data, along with patient-logged information such as food intake and exercise levels, to generate personalized recommendations.

Beyond aiding weight loss, the system is designed to help users comprehend their body’s reactions to particular foods and exercise routines. 

This understanding facilitates appropriate behavioral adjustments for long-term weight management.

While Signos did not disclose the exact number of current users for its glucose monitoring system, Fouladgar-Mercer stated that tens of thousands of individuals have utilised it over time. 

Following approval, Signos has expanded its CGM inventory and software capabilities to accommodate a significant increase in demand.

The post US FDA greenlights first glucose monitoring system for weight loss appeared first on Invezz

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