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The Food and Drug Administration (FDA) has approved the first over-the-counter continuous glucose monitor (CGM) indicated for children aged 2 years and older who do not use insulin, according to an agency news release. The wearable device continuously measures glucose levels and displays readings and trends through a smartphone application, which can be used on a caregiver’s device. Real-time glucose data—measured every 15 minutes—is intended to help children and their parents better understand the effects of meals, physical activity, and other lifestyle factors on glycemic patterns. The monitoring system does not provide alerts for hypoglycemia and is not appropriate for patients with problematic low blood sugar, according to the agency. Reported adverse effects were generally mild and included skin irritation, discomfort, and localized infection at the sensor site. FDA previously approved the system in March 2024 for adults.
Rising applications: Approval of the Dexcom Stelo CGM system for use in kids comes at a time when prediabetes and type 2 diabetes are becoming more common among pediatric patients. In 2023, an estimated 8.4 million adolescents aged 12-17 years had prediabetes, according to Centers for Disease Control and Prevention.