First Nonprescription Continuous Glucose Monitor: Will it Expand Diabetes Care Access?

According to the American Diabetes Association, the availability of continuous glucose monitoring (CGMs) offers health care providers and patients with a tool to monitor glucose levels closely, provides valuable information for prescribers to make therapy and lifestyle adjustments when warranted, and reduces the burdens of frequent blood glucose meter finger sticks throughout the day in eligible patients.¹ Various studies documented the clinical benefits associated using CGMs and indicate that CGM is a critical component of managing diabetes and is correlated with significant improvements in glycemic values, time in range, HbA1c values, and overall clinical outcomes in patients with T2DM.^2,3 Most recent data indicates that an estimated 2.4 million individuals use CGMs, and data from a recent mixed-method study revealed that 90% of participants were interested in using CGMs due to access to regular data, fewer finger sticks throughout the day, and convenience, but insurance coverage and costs are still significant concerns. However, most study participants (83%) had never used a CGM.4 Among participants not open to using CGMs, some patients cited unfamiliarity with CGMs and cost concerns, and some did not feel they needed to use them.⁴

Recent Approval

On March 5, 2024, the FDA approved the first OTC CGM to be marketed as the Dexcom Stelo Glucose Biosensor System.^5,6 It is an integrated CGM (iCGM) indicated for use in individuals 18 years and older who are not using insulin, including individuals diagnosed with diabetes using oral antidiabetic medications or individuals without diabetes who want to learn how to better recognize how factors such as diet and exercise may affect blood glucose levels.^5,6 Additionally, the manufacturer and FDA indicate this novel CGM is not intended for use in individuals with problematic hypoglycemia.^5,6 The CGM also has a small sensor that should be worn on the upper arm; each sensor can be worn for up to 15 days before replacement with a new sensor. The sensor delivers a glucose reading 24/7 to the user’s cell phone or smartwatch, if applicable, via an app.^5,6

In the press release, the FDA states, “Users should not make medical decisions based on the device’s output without talking to their health care provider.”⁶

In the press release, Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, stated, “CGMs can be a powerful tool to help monitor blood glucose. Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider. Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for US patients.”⁶

Statements from Pharmacists

A retail pharmacist stated, “The FDA approval of the first OTC CGM is exciting and provides patients, especially those considered prediabetic, with a tool to monitor their blood glucose values and take control of their health, which could prevent progression to T2DM. I have encountered many patients who have always wanted to use a CGM, but their insurance did not cover the device, and they couldn’t afford the out-of-pocket costs. Hopefully, having access to an OTC option will provide patients with an affordable option. The cost will be an important factor for many patients. I encourage patients to discuss the use of a CGM with their HCPs to determine what is best for each patient since some patients like them and others don’t.”

A retail pharmacist stated, “Many of my patients have expressed interest in CGMs after seeing commercials on TV, but insurance did not cover them. Access to an OTC CGM enables patients to take an active role in their health and, for some patients, a preventative approach. Many patients using blood glucose meters complain about needing several finger sticks daily and are often noncompliant with taking measurements. As the number of patients diagnosed as prediabetic continues to climb, patients must take the necessary steps to lower HbA1c values to minimize risks and prevent progression to T2DM. The OTC CGM allows patients to gather valuable information that should be shared with their HCP to devise individualized goals and treatment plans. Patients should remember that routine health care and monitoring via HCP is still essential.”

Conclusion

More than 38 million individuals in the US have diabetes, and the incidence continues to grow. Annually, the number of individuals who have been classified as prediabetic continues to increase, with the CDC indicating that an estimated 98 million adults (representing more than 1 in every 3 individuals) are considered prediabetic.⁷ More alarmingly, of those who are prediabetic, more than 80% of these individuals are unaware of this status.⁷

The availability of a CGM without a prescription has the potential to expand patient access; however, patients should be reminded that there is no substitute for routine health care with their primary health care provider (HCP) and should always discuss results with their HCPs. If results from a CGM do not align with the patient’s symptoms, patients should also be advised to check blood glucose with a glucose meter, adhere to guidelines as directed by their HCP to manage glucose levels, and/or consult HCP for further direction.⁵ 

The price of the OTC CGM remains unknown, and that may be a deciding factor for many consumers. The manufacturer indicates that Dexcom Stelo will be available for purchase online sometime in the summer of 2024. The impact of its availability as an OTC product remains to be seen, but it provides patients with another resource to gather valuable information about their blood glucose levels, which can aid in preventing and managing diabetes.

Empowering patients through ongoing and effective patient-centered education initiatives about diabetes prevention and management is a critical step in motivating patients to take an active role in their health and improve clinical outcomes. Hopefully, the availability of OTC CGM will enable patients to take control of their health, which can positively impact and optimize many patients' health and overall well-being.

Reference

1. American Diabetes Association Professional Practice Committee. 7. Diabetes technology: standards of care in diabetes-2024. Diabetes Care. 2024;47(Suppl 1):S126-S144. doi:10.2337/dc24-S007
2. Grace T, Salyer J. Use of real-time continuous glucose monitoring improves glycemic control and other clinical outcomes in type 2 diabetes patients treated with less intensive therapy. Diabetes Technol Ther. 2022;24(1):26-31. doi:10.1089/dia.2021.0212
3. Rodbard D. Continuous glucose monitoring: a review of recent studies demonstrating improved glycemic outcomes. Diabetes Technol Ther. 2017;19(S3):S25-S37. doi:10.1089/dia.2017.0035
4. Sears L, Imrisek SD, Hoy-Rosas J, et al. CGM attitudes and adoption among people with type 2 diabetes using one drop. Poster presented at the 82nd Scientific Session of the American Diabetes Association; New Orleans, LA; 2022.
5. Stelo by Dexcom first glucose biosensor cleared by FDA as over-the-counter. Dexcom. Published March 5, 2024. Accessed April 22, 2024. https://investors.dexcom.com/news/news-details/2024/Stelo-by-Dexcom-First-Glucose-Biosensor-to-be-Cleared-by-FDA-as-Over-the-Counter/default.aspx
6. FDA clears first over-the-counter continuous glucose monitor. News release. FDA. Published March 5, 2024. Accessed April 22, 2024. https://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor
7. Diabetes fast facts. CDC. Published April 4, 2023. Accessed April 22, 2024. https://www.cdc.gov/diabetes/basics/quick-facts.html