FDA Clears First OTC Continuous Glucose Monitor for Pediatric Patients

The FDA cleared the first OTC continuous glucose monitor (CGM) for children, marking a significant expansion in the accessibility of metabolic health tools. The agency cleared Dexcom’s Stelo Glucose Biosensor System for use in individuals aged 2 years and older who do not use insulin.¹

This decision follows the system's initial OTC clearance for adults in March 2024 and reflects a growing federal commitment to supporting medical device use. The move is particularly aimed at addressing the rising prevalence of prediabetes in children, providing a tool for caregivers to build glycemic awareness and track patterns in response to lifestyle factors.¹

About The OTC CGM

The Stelo system utilizes a wearable sensor paired with a smartphone application to display glucose trends every 15 minutes, with each sensor lasting up to 15 days. Although the device offers unprecedented data, the FDA emphasizes that it is not intended for patients with problematic hypoglycemia or those on dialysis, as it lacks the necessary alert systems for dangerous low blood sugar events. This clearance also aligns with the FDA’s Home as a Health Care Hub Initiative, which seeks to integrate patient-centered technology more seamlessly into daily life.¹

This pediatric clearance is part of a broader surge in the OTC glucose monitoring market. The FDA also cleared Abbott’s Lingo and Libre Rio systems. The Libre Rio is designed for noninsulin-using adults with type 2 diabetes, and the Lingo system targets general wellness and metabolic health in the broader adult population.²

Furthermore, the Signos Glucose Monitoring System was recently cleared as the first OTC monitor specifically for weight management, translating glucose fluctuations into personalized lifestyle recommendations.³

The Role of Community Pharmacists in OTC CGMs

As these devices move from behind the prescription counter to the retail shelf, community pharmacists are emerging as the frontline experts for patient education. Morgan Stewart, a clinical associate professor at the University of Texas at Austin, noted that pharmacists are uniquely positioned at the point of access to help patients understand these devices.⁴

“With CGMs becoming more and more common and being dispensed in the community setting, I think pharmacists are very uniquely positioned to help patients understand their device right at the point of access where they're picking up,” Stewart said.

However, the shift to OTC status presents unique challenges. Research indicates that the current median counseling time in community settings is just under 2 minutes, which is often insufficient for comprehensive device training. Additionally, workflow constraints and a lack of specific reimbursement models can hinder the depth of education provided.⁴

To maximize the clinical benefit of these monitors, pharmacists should take an active role during the initial purchase, assisting with the physical application of the sensor and the setup of smartphone applications. Beyond technical support, pharmacists can help patients interpret the overwhelming amount of data these devices produce, transforming numbers into actionable behavior changes. For example, seeing real-time glucose spikes can empower a patient to make immediate dietary adjustments, such as choosing to skip a sugary snack after seeing its direct impact on their levels.⁵

To address the training gap, the American Pharmacists Association introduced a 12-hour CGM certificate training program designed to educate pharmacists on device technology, clinical application, and billing strategies. By becoming experts in this technology, pharmacists can not only improve patient outcomes—such as lowering hemoglobin A_1C and reducing hospital admissions—but also demonstrate their value as critical partners in personalized, tech-driven diabetes care. As the prevalence of diabetes is projected to reach 1.31 billion people worldwide by 2050, the integration of OTC CGMs into pharmacy practice represents a vital opportunity to address a major public health concern.⁵

“No matter what practice setting you're in, you probably encounter some patients with diabetes, and so whether it be through recommending to providers to get them on CGM devices just to help them be empowered to make decisions throughout their day when it comes to what they're eating and what they're doing,” Lindsey Miller, PharmD, clinical assistant professor of pharmacy practice at the University of Mississippi, said.⁵

READ MORE: Diabetes Resource Center

Are you ready to elevate your pharmacy practice? Sign up today for our free Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips straight to your inbox.

REFERENCES

1. FDA clears first over-the-counter continuous glucose monitor for children. News release. FDA. June 12, 2026. Accessed June 15, 2026. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor-children

2. Meara K. FDA approves 2 new OTC continuous glucose monitors. Drug Topics. June 11, 2024. Accessed June 15, 2026. https://www.drugtopics.com/view/fda-approves-2-new-otc-continuous-glucose-monitors

3. Gallagher A. FDA clears OTC glucose monitor for weight management. Drug Topics. August 22, 2025. Accessed June 15, 2026. https://www.drugtopics.com/view/fda-clears-otc-glucose-monitor-for-weight-management

4. Meara K, Stewart M. Q&A: pharmacists play key role in expanding access to CGMs. Drug Topics. August 19, 2025. Accessed June 15, 2026. https://www.drugtopics.com/view/pharmacists-play-key-role-in-expanding-access-to-cgms

5. Gallagher A. Q&A: CGMs empower patients to take control of diabetes care | APhA 2025. April 2, 2025. Accessed June 15, 2026. https://www.drugtopics.com/view/q-a-cgms-empower-patients-to-take-control-of-diabetes-care