FDA Approves First Over-the-Counter Continuous Glucose Monitor, Stelo
Key Insights
The FDA has approved Stelo (search), the first over-the-counter continuous glucose monitor (CGM) for adults with diabetes (search) who do not use insulin.
Stelo (search), a small sensor paired with a smartphone app, allows users to track and understand their blood sugar levels without fingersticks.
While enhancing accessibility, Stelo (search)'s high cost may limit its adoption, prompting calls for cost reduction strategies by healthcare advocates.
The U.S. Food and Drug Administration (FDA) has approved Stelo (search), the first over-the-counter continuous glucose monitor (CGM) for adults with diabetes (search) who do not use insulin. This decision aims to improve access to glucose monitoring for the millions of Americans living with diabetes, particularly those without health insurance or with limited access to healthcare.
Accessibility and Convenience
Stelo (search), developed by Dexcom (search), is a sensor about the size of a quarter that is worn on the belly or arm and paired with a smartphone application. It provides real-time information about blood sugar levels, allowing users to track and understand their glucose fluctuations throughout the day. This eliminates the need for traditional fingerstick checks, which require individuals to prick their fingertips with a small needle to obtain a blood sample.
Jeff Shuren, FDA Director for the Center for Devices and Radiological Health, emphasized that Stelo (search)'s over-the-counter approval enhances health accessibility by providing people with “information about their health, regardless of their access to a doctor or health insurance.”
Clinical Benefits and Limitations
Continuous glucose monitoring offers several advantages over fingerstick readings. Fingerstick checks provide a measurement of blood sugar level at a single point in time, whereas CGMs supply users with real-time data, enabling them to modify their diet or lifestyle and pinpoint potential causes of irregularities. Studies have shown that people with diabetes (search) who use CGMs experience reduced hypoglycemia (search) and improved average blood glucose levels (A1C).
Real-time blood sugar level measurements can offer life-saving benefits for diabetes (search) management by delaying or avoiding hospitalizations for complications such as amputations, kidney failure, or death.
Cost Considerations
Despite the FDA's approval for over-the-counter sales, Stelo (search)'s high price tag remains a barrier for many. While fingerpick test strips cost about $120 a month without insurance, Stelo sensors cost over $300 a month, plus an additional $300 for a new transmitter every three months. Given that nearly 30 percent of diabetes (search) patients already neglect to monitor glucose levels because of cost, Stelo may remain financially unobtainable for many.
Some health care advocates urge federal and state regulators to reduce the costs of glucose monitoring technology by focusing on pharmacy benefit managers, third parties responsible for negotiating drug price discounts with manufacturers. These negotiations often result in higher out-of-pocket costs for continuous glucose monitors, regardless of an individual’s insurance coverage.
Future Implications
FDA’s clearance of Stelo (search) for over-the-counter use opens the door for future devices that enable “glucose curious” individuals to monitor health data without a prescription. Michael B. Natter, clinical assistant professor at New York University Grossman School of Medicine, suggests that the device could possibly be used as a preventative tool for individuals with prediabetes (search) or to help detect undiagnosed diabetes (search). However, he cautions that people without diabetes may misinterpret glucose values, especially after meals when it is normal to experience blood sugar spikes.
Stelo (search) sensors became available without a prescription last month.