About 25 million people stand to gain from the FDA's recent approval of the first over-the-counter continuous glucose monitor (CGM). That means fewer finger pricks and greater access for patients with type 2 diabetes who do not use insulin.
Soon, patients 18 and older will be able to purchase an electronic sensor that regularly monitors and records glucose trends, then analyzes the information in real time. We won't know the cost of the device until it comes out this summer, but we do know that a lack of health insurance and prescriptions will no longer be barriers to patients who want to use it.
The Benefits of CGMs
Among patients in my practice who have used continuous glucose monitors (historically through a prescription), most have been satisfied. They report that it helps them make better-informed decisions about how to manage their glucose levels. There are some, however, who feel it either provides too much information or creates stress, or who try too hard to maintain values in a narrow range.
Patients who learn about these devices generally want to use them, though only about 3% of patients who have type 2 diabetes do so. Often, lack of access to a doctor or prescription, or lack of health insurance coverage, may create barriers. The American Diabetes Association points to cost and strict Medicaid coverage policies as obstacles. This new, wider availability of the devices could change that and offer an opportunity for patient engagement.
CGMs offer a detailed look at how patients' decisions affect their glucose levels. With the help of tracking and a physician, patients can learn to assess what happens when they eat, or avoid, certain foods. While tools like a food journal can be helpful, they're more labor-intensive and don't provide the same level of information about changes in glucose levels. Furthermore, CGMs can also help show the impact physical activity has on glucose levels.
Patients can share the data from CGMs with doctors so we can learn, anticipate, and discuss trends that affect glucose levels. When patients regularly monitor and manage their glucose levels, it can help minimize dangerous, long-term health outcomes such as kidney failure, vision loss, and nerve damage.
Barriers to CGM Use
Approximately 2.4 million people in the U.S. with diabetes are already using CGMs for the purpose of better managing their condition, according to one industry estimate. It may seem like a big number, but it doesn't tell the full story of who does and does not have access to the devices. And, millions more could be using these devices.
Studies show that Americans who do not have access to CGMs are generally poor, older, Black and other people of color, and on Medicaid -- populations in which rates of diabetes are high. Hopefully that picture will change with the prescription requirement removed, as access to care is often a barrier for this population. Of course, cost remains a possible downside, but we won't know much about that until the over-the-counter CGM becomes available this summer.
Some have asked whether there is a risk associated with people using CGMs who do not have diabetes. While there is no data showing benefit in individuals without diabetes, there is minimal medical risk associated with the device itself. Warnings about the approved device focus on ensuring that patients with low glucose levels do not use it for their blood-sugar management.
In general, there can be risks associated with reacting to an inaccurate reading or over-interpreting borderline low glucose numbers. Patients with diabetes who may have received an inaccurate reading should confirm glucose levels with a finger prick.
In the meantime, most of us who treat patients with diabetes are looking for every possible way to help our patients manage their glucose levels so they can avoid potentially life-altering complications. If over-the-counter CGMs make that process easier -- or if they motivate our patients to closely monitor their health -- then the FDA approval is a positive step.
A staggering number of Americans have type 2 diabetes. We need every tool at our disposal to help patients because they face a lifetime of learning how to optimize their care. Hopefully the FDA's approval of this electronic device will make a big difference.
Yael Tobi Harris, MD, PhD, serves as chief of the Division of Endocrinology, Diabetes, and Metabolism in the Department of Medicine at Northwell Health and the Zucker School of Medicine.