Following recent FDA approval of its over-the-counter (OTC) continuous glucose monitor (CGM) for pediatric use, Dexcom, Inc., announced new AI-enabled features for the Stelo Glucose Biosensor System, along with plans to expand the device’s availability internationally.

The updates include a redesigned smartphone app scheduled for release in the US in July. New features include AI-generated coaching, meal recognition, and enhanced tracking of glucose patterns in relation to diet, exercise, sleep, and other lifestyle factors.

In 2024, the Stelo system became the first prescription-free CGM approved by the FDA for adults who do not use insulin. The agency emphasized that the system was not designed to provide alerts for hypoglycemia and should not be used for that purpose.

“Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for US patients,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a press statement at the time of the approval.

In early June, the FDA expanded the indication to include children aged 2 years or older who do not use insulin.

AI Features Aim to Provide More Context

The system includes a wearable sensor that measures glucose levels every 15 minutes and transmits the data to a smartphone app. Each sensor lasts up to 15 days before requiring replacement.

According to Dexcom, the updated app will allow users to photograph meals, after which the app will identify foods and provide information about their potential effects on glucose levels.

Additional features include expanded pattern recognition to identify relationships between glucose trends and activities such as eating, exercise, travel, and sleep. The app will also introduce AI coaching to provide individualized suggestions based on users’ glucose patterns, as well as automated daily and weekly summaries describing trends observed across food intake, activity, sleep, and stress.

International Expansion Planned

Dexcom also announced plans to introduce Stelo CGM outside the US beginning later this year, with launches expected through 2027 in the UK, Australia, New Zealand, and South Korea.

Although Stelo is currently the only FDA-approved OTC CGM system available for both children and adults who do not use insulin, several FDA-approved prescription CGMs are available for children and adults with type 1 or type 2 diabetes, including Abbott’s medical-grade FreeStyle Libre and the Dexcom G7.

In its announcement of expanded pediatric approval, the FDA cautioned that “users and their caregivers should consult their healthcare provider before making any medication adjustments based on the device’s output.”

The agency also noted that the system is not recommended for people with hypoglycemia or those receiving dialysis. Individuals with a history of disordered eating or eating disorders are recommended to consult with their healthcare provider before using the device.

Expert Opinion: Education Will Remain Essential

Commenting on the CGM developments, Alaina Vidmar, MD, medical director of Obesity Medicine and Bariatric Surgery Program at Children’s Hospital Los Angeles in Los Angeles, said the new technologies could make glucose data more actionable by reducing the burden of self-monitoring.

“Many young people struggle to consistently log meals or recognize patterns across nutrition, exercise, sleep, and stress,” Vidmar told Medscape Medical News. “Automating these processes may improve adherence and help users identify practical, individualized opportunities for behavior change.”

However, she cautioned that the value of AI coaching will depend on how well it is supported by evidence and presented to users.

“The key will be whether these AI-generated insights are evidence-based, personalized, and presented in a way that encourages sustainable habits rather than information overload,” she said. “Technology is most effective when it supports behavior change without adding unnecessary complexity or anxiety.”

Vidmar also emphasized that glucose data should be interpreted carefully, particularly as OTC CGMs become more widely available.

“Glucose responses vary substantially between individuals, and even within the same individual from day to day. Not every glucose excursion is clinically meaningful,” she said. “Users should avoid overinterpreting isolated values. For children in particular, education remains essential.”

“While OTC access may increase availability and empower families, it should complement, not replace, guidance from healthcare professionals when evaluating symptoms, managing diabetes, or making significant dietary or treatment decisions.”

She also noted the potential for patients to experience increased anxiety or an unhealthy preoccupation with glucose data if readings are interpreted without appropriate context.

“Overall, these advances represent an important step toward making metabolic health data more accessible and actionable, but their greatest value will come when they are paired with education, clinical context, and evidence-based recommendations.”

Vidmar reported no relationships with Dexcom or Stelo during the past 2 years. In 2022, she received grant funding from Dexcom to conduct an investigator-initiated trial using the Dexcom product; that study has since concluded.