New FDA-Cleared Product: CGM + AI for Weight Management

Original Article: https://www.medscape.com/viewarticle/new-fda-cleared-product-cgm-ai-weight-management-2025a1000mva

A new tool combining continuous glucose monitoring (CGM) with artificial intelligence (AI) has been cleared by the U.S. Food and Drug Administration (FDA) to help adults manage their weight. The product, called the Signos Glucose Monitoring System, marks the first time a CGM-based system has been approved for over-the-counter use in people who do not take insulin.

How the System Works

The system uses the Dexcom Stelo sensor to track blood sugar levels in real time. These readings connect to an AI-powered app that also collects information about meals, exercise, and weight. By analyzing patterns, the app offers tailored suggestions—such as recommending a short walk after a meal that usually causes a blood sugar spike.

The system can also sync with Apple Health, Google Health Connect, smartwatches, and smart scales, making it easy to track multiple aspects of health in one place.

Who It’s For

This product is designed for adults aged 18 and older who are not on insulin therapy. It is meant to provide insights into how daily habits like eating, sleeping, and moving affect blood sugar and weight. While it can flag high or low glucose levels, the tool is not meant to replace medical care, and users are advised to consult their healthcare providers before making major changes.

Access and Cost

The program is offered as a subscription. A three-month plan costs about $139 per month, while a six-month plan costs about $129 per month. Currently, insurance coverage is limited, though some users may be able to pay with health savings or flexible spending accounts.

Expert Insights

Experts say the system could be helpful for people looking to understand their body’s response to food and exercise, especially those struggling with weight. However, it’s not a stand-alone solution. Long-term studies are still needed to see whether these tools lead to lasting behavior change and weight control.

Why It Matters

Obesity and related conditions are growing public health challenges. This new system could become a helpful tool in supporting healthier lifestyles.