The Food and Drug Administration has approved the first over-the-counter continuous glucose monitor for children under 18, a move that opens up glucose tracking technology to families without a prescription. The device is designed for children with diabetes who take oral medication to manage their condition. It is not intended for children who require insulin injections.
The device is called the Stelo Glucose system, according to Healthline. It uses a wearable sensor paired with a smartphone app to continuously measure, record, analyze, and display glucose levels. The app updates glucose measurements and trends every 15 minutes. Each sensor lasts up to 15 days before it needs to be replaced.
The FDA had previously approved an over-the-counter version of the Stelo monitor for adults 18 and older in March 2024. The new clearance extends that access to younger users, though federal regulators specified that children must use the device only under an adult caregiver's supervision.
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 issued several cautions alongside the approval. 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 is also not intended for people on dialysis. The FDA added that children with eating disorders should consult a healthcare professional before use.
Researchers have described continuous glucose monitor technology as having revolutionized diabetes care. Studies have found the devices beneficial for people with type 1 diabetes, type 2 diabetes, and gestational diabetes. A February 2025 study specifically found that continuous glucose monitors have helped children manage type 1 diabetes.
"[The glucose monitors] have been very helpful in managing diabetes," said Graham Tse, MD, a pediatrician and chief medical officer of MemorialCare Miller Children's.
There are currently four basic continuous glucose monitor systems approved for use in the United States. Most are prescribed to individuals already diagnosed with diabetes. The first real-time continuous glucose monitor was released by Dexcom in 2006. Previous research involving the Stelo system has reported mild side effects among participants, including local infection, skin irritation, pain, and discomfort.
Regulatory officials said the new device will make it easier for parents and children to manage conditions such as diabetes, and that broader access to the technology was a driver behind the decision.
