Fact Check: Are cgm over the counter?

Are Continuous Glucose Monitors (CGMs) Available Over the Counter?

Introduction

The claim that continuous glucose monitors (CGMs) are now available over the counter (OTC) stems from recent announcements regarding FDA approvals for specific devices. This development marks a significant change in how these medical devices can be accessed by consumers, particularly those without diabetes. However, the implications of this claim, including the devices' availability and the regulatory framework surrounding them, warrant a thorough examination.

What We Know

1. FDA Approval: On March 5, 2024, the U.S. Food and Drug Administration (FDA) announced the clearance of the first OTC CGM, specifically the Dexcom Stelo device. This marked a pivotal moment as it allowed consumers to purchase CGMs without a prescription for the first time in the U.S. 12.

2. Additional Devices: Following the approval of the Stelo, other CGMs, such as Abbott's Lingo and Libre Rio, were also cleared for OTC use, expanding the options available to consumers. As of June 2024, Stelo and Lingo were available for purchase, while Libre Rio was still pending availability 34.

3. Target Users: The FDA's approval indicates that these devices are suitable for individuals managing diabetes, particularly those not on insulin. The Stelo device, for example, provides continuous glucose monitoring and can be worn for up to 15 days 10.

4. Consumer Access: The shift to OTC availability is expected to enhance access for consumers who wish to monitor their glucose levels for health management, lifestyle choices, or preventive health measures 58.

Analysis

The claim that CGMs are available over the counter is supported by credible sources, primarily the FDA itself, which is a reliable authority on medical device approvals. The FDA's announcement is corroborated by multiple news outlets and health information websites, which report on the implications of this change for consumers 12348.

Source Reliability

• FDA: As a government agency, the FDA is a highly credible source. Its announcements are based on rigorous scientific evaluation and regulatory standards.
• News Outlets: Sources like Reuters and GoodRx provide well-researched articles that summarize the FDA's findings and implications for consumers. However, it is essential to consider potential biases; for instance, GoodRx has a vested interest in promoting health-related products and services, which may influence its presentation of information 23.
• Health Websites: Websites like Type2Diabetes.com and Reason.com offer insights into the broader implications of OTC CGMs, but they may also reflect specific viewpoints or agendas, particularly regarding health freedom and consumer choice 46.

Conflicts of Interest

Some sources may have conflicts of interest, particularly those affiliated with companies that manufacture or sell CGMs. For example, Dexcom's own announcements about the Stelo device 9 are promotional in nature and may not provide an unbiased perspective on the device's efficacy or the implications of its OTC status.

Methodological Concerns

While the FDA's approval process is thorough, the long-term effects of OTC CGMs on consumer health and behavior remain to be studied. Questions arise regarding how consumers will interpret and act on the data provided by these devices without professional guidance. More research is needed to understand the impact of increased access to CGMs on health outcomes, particularly for non-diabetic users.

Conclusion

Verdict: True

The claim that continuous glucose monitors (CGMs) are available over the counter is substantiated by the FDA's recent approvals of devices such as the Dexcom Stelo and Abbott's Lingo. This development represents a significant shift in accessibility, allowing consumers to purchase these devices without a prescription. The evidence supporting this claim includes official FDA announcements and corroborating reports from reputable news outlets.

However, it is important to note that while these devices are now available OTC, their use, particularly among individuals without diabetes, raises questions about consumer understanding and health outcomes. The FDA's approval indicates suitability for certain users, but the long-term implications of widespread OTC access remain unclear and warrant further investigation.

Readers should also be aware of potential biases in the sources of information regarding CGMs, particularly those affiliated with manufacturers. As always, it is advisable to critically evaluate information and consult healthcare professionals when considering the use of medical devices.