The US Food and Drug Administration cleared for marketing Dexcom's Stelo Glucose Biosensor System, an over-the-counter continuous glucose monitor indicated for people aged 2 years and older who do not use insulin.
According to the US Food and Drug Administration (FDA), the device is indicated for children, including those with diabetes managed with oral medication, and for people who want to understand how diet, exercise, and other lifestyle factors affect glucose levels.
The Stelo system uses a wearable sensor paired with a smartphone application to continuously measure, record, analyze, and display glucose values. The application provides glucose measurements and trends every 15 minutes and can be used on a compatible smartphone or other smart device, including a caregiver’s device. Each sensor is designed to last up to 15 days, although the FDA noted that wear time may be shorter in pediatric patients.
The FDA stated that the clearance was supported by previous clinical study data from pediatric and adult populations, as well as real-world evidence derived from current integrated continuous glucose monitor use among pediatric and adult patients. According to the agency, these data were used to understand expected device performance in pediatric patients over the intended 15-day wear period.
In a previous study, participants reported mild adverse events, including local infection, skin irritation, and pain or discomfort.
The FDA stated that pediatric patients should use the device under adult caregiver supervision. Additionally, the agency stated that the system is not for patients with problematic hypoglycemia because it does not provide alerts to patients when glucose is low. It is also not intended for patients receiving dialysis. Patients with a history of disordered eating or eating disorders should consult a health care provider before using the device.
According to the FDA, the clearance aligns with the agency’s Home as a Health Care Hub Initiative, which focuses on supporting the development of devices intended for use in home settings.
Source: FDA
