Fact Check: Are cgm over the counter?

Are Continuous Glucose Monitors 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). This development marks a significant shift in how these devices can be accessed by consumers, particularly those managing diabetes or those interested in monitoring their glucose levels for other health reasons. However, the specifics of this claim require careful examination to understand the implications and the current status of OTC CGMs.

What We Know

1. FDA Approval: On March 5, 2024, the FDA announced the clearance of the first OTC continuous glucose monitor, the Stelo by Dexcom, which allows consumers to purchase the device without a prescription 12. This was followed by additional approvals for Abbott's Lingo and Libre Rio models 24.

2. Availability: As of December 2024, Dexcom's Stelo and Abbott's Lingo have been launched and are available for purchase without a prescription. However, the Libre Rio is not yet available for sale 234.

3. Target Audience: The FDA's approval specifies that these devices are intended for individuals over 18 years old who do not use insulin and are not at risk for hypoglycemia 6. This restriction raises questions about the broader applicability of OTC CGMs for all consumers.

4. Consumer Empowerment: The introduction of OTC CGMs is seen as a way to empower consumers with health insights without the need for a doctor’s prescription, potentially increasing access to glucose monitoring technology 37.

Analysis

Source Reliability

• FDA Announcements: The FDA is a primary source for regulatory information and is generally considered a reliable authority. Their announcements are based on rigorous evaluations of safety and efficacy 1.

• Medical and Health Publications: Sources like Medscape and GoodRx provide detailed information about the availability and implications of OTC CGMs. However, while they are informative, they may also have a vested interest in promoting health products, which could introduce bias 26.

• Industry News: Publications such as Reason.com and MedTech Dive report on the implications of OTC CGMs, but they may also reflect industry perspectives that could skew the interpretation of the data 37.

Conflicts of Interest

Some sources, particularly those affiliated with manufacturers like Dexcom and Abbott, may have conflicts of interest. For example, press releases from Dexcom promote their products directly, which could lead to a bias in how the information is presented 59.

Methodology and Evidence

The FDA's approval process for OTC CGMs involved evaluating clinical data to ensure safety and effectiveness. However, the specific studies and methodologies used in these evaluations are not detailed in the announcements, which leaves a gap in understanding the robustness of the evidence behind the claims of safety and efficacy for all potential users, particularly those outside the specified demographic 110.

Additional Context

The shift to OTC availability for CGMs is significant in the context of diabetes management and health monitoring. Historically, glucose monitoring required a prescription, which created barriers for many potential users. The implications of this change could lead to increased self-management of health, but it also raises concerns about the accuracy of self-diagnosis and the potential for misuse among individuals who may not fully understand the implications of glucose monitoring.

Conclusion

Verdict: True

The claim that continuous glucose monitors (CGMs) are now available over the counter is substantiated by recent FDA approvals, specifically for devices like the Stelo by Dexcom and Abbott's Lingo. These devices can be purchased without a prescription, marking a significant change in accessibility for consumers.

Key evidence supporting this verdict includes the FDA's official announcements regarding the clearance of these devices and their availability for purchase as of December 2024. However, it is important to note that the FDA's approval comes with specific restrictions, limiting the target audience to individuals over 18 who do not use insulin and are not at risk for hypoglycemia. This nuance indicates that while CGMs are available OTC, their use may not be appropriate for all consumers.

Despite the positive implications of increased access to glucose monitoring technology, there are limitations in the available evidence regarding the safety and efficacy of these devices for all potential users. The FDA's approval process did not disclose detailed methodologies or studies, which leaves some uncertainty about the robustness of the claims made.

Readers are encouraged to critically evaluate information regarding OTC CGMs and consider their individual health needs and circumstances when deciding to use such devices.

Sources

1. U.S. Food and Drug Administration. "FDA Clears First Over-the-Counter Continuous Glucose Monitor." FDA.
2. GoodRx. "7 Over-the-Counter Continuous Glucose Monitoring FAQs Answered." GoodRx.
3. Reason.com. "Glucose Monitors Are Finally Available Over the Counter." Reason.
4. Type2Diabetes.com. "Comparing OTC Continuous Glucose Monitors (CGMs)." Type2Diabetes.
5. Dexcom. "Stelo by Dexcom, the First Over-the-Counter Glucose Biosensor in the U.S., Is Now Available." Dexcom.
6. Medscape. "First Over-the-Counter Continuous Glucose Monitor Launches." Medscape.
7. MedTech Dive. "Abbott and Dexcom are launching the first over-the-counter CGMs." MedTech Dive.
8. GoodRx. "How to Get A Continuous Glucose Monitor OTC Without Diabetes." GoodRx.
9. Stelo. "Stelo Wearable Glucose Biosensor." Stelo.
10. The Healthy. "Experts Just Approved the First Over-the-Counter Wearable Blood Sugar Monitor." The Healthy.