on PinterestThe FDA approved the first nonprescription sale of Dexcom’s continuous glucose monitor for children ages 2 to 18 with diabetes.
on PinterestThe FDA approved the first nonprescription sale of Dexcom’s continuous glucose monitor for children ages 2 to 18 with diabetes. Svetikd/Getty Images
- The Food and Drug Administration (FDA) approved the first over-the-counter continuous glucose monitor for children under 18.
- Experts say the over-the-counter version will make this helpful technology more widely available to families who need diabetes care.
- The devices could help parents and children make healthy lifestyle decisions, but the technology should still be used under a medical professional’s supervision.
Federal regulators have authorized the first over-the-counter continuous glucose monitor (CGM) for children.
Officials at the Food and Drug Administration (FDA) approved the nonprescription sale of the Stelo Glucose Biosensor System manufactured by Dexcom for children ages 2 to 18 years.
The wearable device is designed for children, including those with diabetes, who receive oral medication to manage their condition. It is not intended for children who need insulin injections.
The device can also be used by children and parents who want to understand how diet, exercise, and other lifestyle changes affect glucose levels.
However, the FDA cautioned that the monitoring system is not intended for individuals with problematic hypoglycemia because it is not designed to alert users when low blood sugar occurs. It’s also not intended for people on dialysis.
In addition, the FDA said individuals with eating disorders should consult their healthcare professional before use. Federal regulators added that children should use the glucose monitor only under an adult caregiver’s supervision.
The FDA approved an over-the-counter version of the Stelo Glucose monitor for individuals 18 years and older in March 2024. Participants involved in previous research have reported mild side effects, including local infection, skin irritation, pain, and discomfort.
The Stelo Glucose system uses a wearable sensor paired with a smartphone app to continuously measure, record, analyze, and display glucose levels. The app displays glucose measurements and trends every 15 minutes. Each sensor lasts for up to 15 days before it must be replaced.
Regulatory officials said the new device will make it easier for parents and children to manage conditions such as diabetes.
“Children deserve access to the best tools available to manage their health,” said Michelle Tarver, MD, PhD, the director of the FDA’s Center for Devices and Radiological Health, in a statement. “[The] clearance reflects the FDA’s commitment to fostering innovation for pediatric patients and supporting the safe and effective use of medical devices where children live, learn, and play,” Tarver continued.
Benefits of continuous glucose monitors
The first real-time continuous glucose monitor was released by Dexcom in 2006.
There are four basic continuous glucose monitor systems approved for use in the United States. They are usually prescribed to individuals who have been diagnosed with diabetes.
Researchers have stated that continuous glucose monitors have revolutionized diabetes care. They point to research that reports that continuous glucose monitor technology is beneficial for people with type 1 diabetes and type 2 diabetes, as well as for individuals with gestational diabetes during pregnancy.
A February 2025 study concluded that continuous glucose monitors have been beneficial in helping children manage type 1 diabetes.
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