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FDA Approves Over-the-Counter Sale of Dexcom CGM
For the first time in the United States, patients can get continuous glucose monitors without a prescription.
On Tuesday, March 5, 2024, the United States FDA cleared the first over-the-counter continuous glucose monitor (CGM), the Dexcom Stelo Glucose Biosensor System. This new approval marks the first time in the US that patients can access CGMs without a prescription from the provider.
The tool is intended for individuals who are not insulin-dependent and may need to monitor their blood sugar levels for multiple reasons. For example, some diabetic patients who are managing their condition with oral medications, diet, or exercise may use the device to monitor how these factors impact their blood sugar.
“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,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in the FDA 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 US patients.”
The device is a wearable biosensor that detects blood glucose levels every 15 minutes and is paired with a smartphone application to measure, record, and analyze blood sugar. Patients can wear each sensor for up to 15 days, at which point they can remove and replace it with a new sensor.
According to the FDA, the device’s risks are similar to other CGMs, including local infection, skin irritation, and pain or discomfort.
CGMS play a critical role for patients with conditions, like diabetes, that may affect their blood sugar. Understanding how certain habits or changes impact blood sugar levels can help guide lifestyle changes and offer insight to providers on how well the condition is being managed.
“Use of CGM can help empower people with diabetes to understand the impact of different foods and activity on their glucose values,” said Tamara Oser, MD, Family Physician, in the Dexcom release. “For people newly diagnosed with type 2 diabetes or not taking insulin, these devices are often not covered by insurance and Stelo presents an opportunity to provide valuable information that can impact their diabetes management.”
Even though the data provided by this CGM can provide valuable insights, the FDA cautions consumers against using it to make medical decisions without the help of a licensed healthcare provider. Instead, patients can present data collected by the CGM to their provider and make informed decisions with the help of a healthcare professional.
