Dexcom adds generative AI to over-the-counter CGMs

 

• Dexcom has launched a generative AI feature for its over-the-counter glucose sensors.

• The feature will analyze patterns in users’ health data to provide more personalized tips, recommendations and education around diet, exercise and sleep, the company said in a press release Tuesday.

• Dexcom’s new capability comes as the Food and Drug Administration is exploring how to regulate generative AI in medical devices. Dexcom spokesperson Janika Kelly said the company evaluated the generative AI feature according to FDA guidance documents and it did not require a premarket submission. “While this is a new territory for the FDA, we are working with them to follow their framework for GenAI,” Kelly wrote in an email.

Dexcom received FDA clearance in March for the first over-the-counter glucose monitor, called Stelo. It’s cleared for adults who don’t take insulin, including people with Type 2 diabetes.

The wellness-oriented device flags glucose spikes, provides information on time-in-range goals, and includes meal and activity logging.

Abbott has also launched its own over-the-counter continuous glucose monitor to challenge Dexcom in the new space.

Dexcom said the generative AI feature will add more personalized information to its weekly insights for users. It does not provide medical advice or recommendations, Kelly said.

“We are also providing feedback to and seeking input from the FDA as we take steps to incorporate GenAI into our product,” Kelly said.

The feature is based on Google Cloud’s Vertex AI development platform and its Gemini large language models. 

Dexcom Chief Operating Officer Jake Leach said in the announcement that the company plans to introduce additional generative AI-powered features over the next year “to help users contextualize their health information and make proactive, informed lifestyle decisions.”

Currently, none of the AI-enabled medical devices authorized by the FDA use generative AI. However, other applications not regulated by the agency use the technology, such as for generating clinical notes for physicians. 

Last month, the agency held its first digital health advisory committee meeting to discuss generative AI and how the FDA should approach regulations.

The FDA has discussed taking a total-product lifecycle approach to regulating AI-enabled devices. One of the Center for Devices and Radiological Health’s priorities for its 2025 fiscal year is to issue draft guidance on lifecycle management considerations and pre-market submission recommendations for AI-enabled devices.

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