Fact Check: Is CGM over the counter?

Is CGM Over the Counter?

The claim that continuous glucose monitors (CGMs) are now available over the counter (OTC) has gained traction following recent announcements from the U.S. Food and Drug Administration (FDA) regarding the clearance of several CGM devices for OTC sale. This development raises questions about the accessibility of these devices for individuals with and without diabetes, as well as the implications for health management.

What We Know

1. FDA Clearance: On March 5, 2024, the FDA announced the clearance of the first OTC continuous glucose monitor, the Dexcom Stelo, which is intended for adults aged 18 and older who are not on insulin therapy. This monitor is designed to continuously measure glucose levels without the need for fingersticks 110.

2. Additional Devices: Following the clearance of the Stelo, Abbott's Lingo and Libre Rio CGMs have also been cleared for OTC use. While the Stelo and Lingo are currently available for purchase, the Libre Rio is not yet on the market 23.

3. Market Context: Continuous glucose monitoring has historically required a prescription in the U.S., although similar devices have been available OTC in other countries for years. The introduction of OTC CGMs is seen as a significant step towards improving access for individuals who may benefit from glucose monitoring, including those without diabetes 9.

4. Consumer Interest: There is an expectation that the availability of OTC CGMs will attract a broader audience, including those who are health-conscious but do not have diabetes. This shift could potentially help individuals make informed lifestyle choices based on their glucose levels 34.

Analysis

The claim that CGMs are now available OTC is substantiated by multiple credible sources, including official announcements from the FDA and reputable medical news outlets. However, it is essential to critically evaluate the reliability of these sources:

• FDA Announcements: The FDA is a primary regulatory body and is generally considered a reliable source for information regarding medical devices. Their announcements are based on rigorous evaluation processes, although they may not always provide comprehensive details about the long-term implications of such approvals 110.

• Medical News Outlets: Publications like MedTech Dive and Healio provide industry insights and updates on medical technology. While they are generally credible, it is important to consider their potential biases, particularly if they have financial ties to the companies involved in the CGM market 310.

• Consumer Health Platforms: Websites like GoodRx offer consumer-friendly information about medical devices and medications. While they can provide useful summaries, their interpretations may lack the depth needed for comprehensive understanding, and they may also have commercial interests 24.

• Company Press Releases: Information from Dexcom and Abbott about their products is typically promotional in nature. While these sources provide details about the features and intended uses of their devices, they may not fully disclose potential limitations or risks associated with OTC use 69.

Conflicts of Interest

It is crucial to note that some sources may have conflicts of interest. For example, articles from company press releases or those that promote specific products may not provide an unbiased view of the implications of OTC availability. Furthermore, the financial interests of companies in the CGM market could influence the portrayal of their products in the media.

Methodology and Evidence

The methodology behind the FDA's clearance process involves clinical trials and safety evaluations, but the specifics of these trials are not always disclosed in public announcements. Additional information about the trial designs, participant demographics, and long-term efficacy data would be beneficial for a more comprehensive understanding of the implications of OTC CGMs.

Conclusion

Verdict: True

The claim that continuous glucose monitors (CGMs) are now available over the counter is true, as evidenced by the FDA's recent clearance of the Dexcom Stelo and other devices for OTC sale. This marks a significant shift in the accessibility of glucose monitoring technology, allowing individuals without diabetes to monitor their glucose levels more easily.

However, while the FDA is a reputable source, it is important to recognize that the long-term implications of OTC availability are not fully understood. The clearance process, while rigorous, does not always provide exhaustive details about the safety and efficacy of these devices in a broader population. Additionally, potential conflicts of interest in reporting and marketing may influence public perception.

Readers are encouraged to critically evaluate the information presented and consider the nuances surrounding the use of OTC CGMs, including their intended audience and the potential need for professional guidance in interpreting glucose data.

Sources

1. FDA Clears First Over-the-Counter Continuous Glucose Monitor. (2024). Retrieved from FDA
2. 7 Over-the-Counter Continuous Glucose Monitoring FAQs Answered - GoodRx. Retrieved from GoodRx
3. Abbott and Dexcom are launching the first over-the-counter CGMs. Here. Retrieved from MedTech Dive
4. How to Get A Continuous Glucose Monitor OTC Without Diabetes - GoodRx. Retrieved from GoodRx
5. The OTC CGM Market: Comparing Stelo, Lingo, & Libre Rio. Retrieved from Sequenex
6. Stelo by Dexcom, the First Over-the-Counter Glucose Biosensor in the U.S., Is Now Available. Retrieved from Dexcom
7. Stelo Wearable Glucose Biosensor | Stelo by Dexcom. Retrieved from Stelo
8. Two OTC continuous glucose monitors won awards at CES. Retrieved from ZDNet
9. Abbott Receives U.S. FDA Clearance for Two New Over-the-Counter Continuous Glucose Monitoring Systems. Retrieved from Abbott
10. FDA clears first OTC CGM for adults with and without diabetes. Retrieved from Healio