FDA clears first OTC CGM for adults with and without diabetes who do not use insulin
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Key takeaways:
- The Dexcom Stelo Glucose Biosensor System was cleared for over-the-counter sale on March 5.
- The CGM was approved for adults with diabetes who use oral medication as well as adults without diabetes.
The FDA cleared for marketing an over-the-counter continuous glucose monitor for adults with or without diabetes, according to an agency press release.
The FDA granted marketing clearance for the Dexcom Stelo Glucose Biosensor System on March 5. The device is the first OTC CGM that adults will be able to purchase without a prescription, according to the release.
The system uses a wearable sensor that is paired with an application on a smartphone or smart device to continuously measure, record, analyze and display glucose values. Sensors can be worn for up to 15 days before being replaced. Blood glucose measurements and trends are updated every 15 minutes in the app.
The CGM can be used by all adults aged 18 years and older who do not use insulin, including adults with diabetes who use an oral medication and those without diabetes who want to better understand how diet and exercise impact their glucose levels. The CGM is not designed for people who experience hypoglycemia. People using the CGM should not make medical decisions based on the device’s output without talking to a health care provider.
“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,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in the press release. “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 U.S. patients.”
Clearance for the Dexcom Stelo was based on data from a clinical study that showed the device performed similarly to other integrated CGMs. Adverse events in the study included local infection, skin irritation and pain or discomfort.
According to an industry press release, the Dexcom Stelo will be available for purchase online beginning in the summer of 2024.
Reference:
Stelo by Dexcom First Glucose Biosensor to be Cleared by FDA as Over-the-Counter. Available at: 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. Published March 5, 2024. Accessed March 6, 2024.
Perspective
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The FDA approval for an OTC CGM device for those with and without diabetes is exciting news. For those with diabetes and not using insulin, many health plans do not support the coverage of CGM devices. While I hold out hope that ongoing research will change this coverage approach, this new OTC option will provide more immediate opportunities for individuals to observe the effects of different foods, physical activity, sleep and stress on glucose excursions, at least for those who can afford it. There is early evidence that immediate feedback with real-time glucose values may have positive effects on changing behaviors and can lead to improved time in target glucose range and lower need for medications, while maintaining similar or better glucose values (Aronson R, et al. Diabetes Obes Metab. 2023;doi: 10.1111/dom.14949. Aleppo G, et al. Diabetes Technol Ther. 2023;doi:10.1089/dia.2023.0268). This would be hugely valuable to both people with diabetes and health plans.
One concern that arises is that those who may benefit most, such as diverse minority communities that are most commonly affected by diabetes and many times at higher risk for complications, may not be able to afford or have access to the amazing technology. Identifying ways to offer the technology to those at most need would be desired.
It will be interesting to see if increased availability has beneficial effects for people at risk for diabetes but not yet diagnosed, such as prediabetes. Changing lifestyle behaviors has been shown to be advantageous, but demonstrating beneficial outcomes and reduced progression to diabetes will be dependent on whether the CGM is sensitive enough to provide information on glucose excursions in the prediabetes population. There are currently few well-conducted, evidence-based studies to inform us (Klonoff DC, et al. J Diabetes Sci Technol. 2022;doi: 10.1177/19322968221110830. Taylor PJ, et al. Diabetes Ther. 2019;doi:10.1007/s13300-019-0572-z. Whelan ME, et al. BMC Public Health. 2021;doi:10.1186/s12889-020-09740-z).
For those without diabetes who decide to use this technology, there are a few caveats that have been observed and will need to be kept in mind. Hypoglycemic ranges trigger alarms with good reason for people with diabetes on glucose-lowering medications, but these ranges can be normal in those without diabetes. Lower glucose values can occur commonly and especially in the first 24 hours of CGM use. Understanding if hyperglycemic and hypoglycemic episodes potentially promote anxiety and how to address this would be important.
Overall, this is an exciting option for all individuals to learn more about how lifestyle interventions and medications may influence health and outcomes. With the right education and greater research, it can become an incredibly valuable tool.
Perspective
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Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP
The clearance of Dexcom’s Stelo as the first OTC CGM product is ground breaking. This is likely to bring CGM to the masses by raising awareness and removing access barriers to obtaining CGM. Now, anyone who wants to try CGM will be able to without depending on a prescription from their health care provider.
I am hopeful the cost will be competitive and affordable for most people to try. The use of CGM can have profound effects on lifestyle changes as people who wear them can see the direct impact of different food choices, physical activity, medications, stress and other factors on their glucose levels.
It will be exciting to see the real-world use of these devices. For example, I could see people with gestational diabetes who do not require insulin deciding to use this instead of using finger sticks four times daily. And even though this is geared toward people with diabetes, I could see many others trying it out, such as those with prediabetes, and the hope is it will help people lead healthier lives. I look forward to seeing this in pharmacies this summer.
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