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How Eversense Differs From Other Continuous Glucose Monitoring Systems
A continuous glucose monitoring system can help people with diabetes manage their blood sugar without the nuisance of performing multiple finger pricks during the day to assess their glucose levels. These systems have been designed to monitor glucose by using a tiny sensor that’s inserted under the skin on the arm and is attached to a monitor. Traditional continuous glucose monitoring systems involve replacing sensors every three to seven days, depending on the model, according to the National Institute of Diabetes and Digestive and Kidney Diseases. In a June 21, 2018, press release, the device’s manufacturer, Senseonics, said Eversense is the first fully implantable device and can be used for 90 days without changing the sensor. Eversense uses a fluorescent chemical that produces a small amount of light when exposed to blood sugar. The light is measured, and the measurements are sent via Bluetooth every five minutes to a mobile app that displays readings, trends, and alerts. The tiny wireless sensor is inserted under the skin on the upper arm, and a lightweight, 1-by-1.5-inch transmitter is affixed to the skin over the sensor with adhesive. The transmitter can be removed and recharged without discarding the sensor. “It has the longest duration in the body for any glucose monitor that the FDA has approved,” says David Klonoff, MD, the medical director of the Diabetes Research Institute at Mills-Peninsula Medical Center in San Mateo, California. Dr. Klonoff has studied continuous glucose monitors. “It’s a significantly longer time period.” RELATED: Tips and Tricks for Stabilizing Your Blood Sugar
If You’re Managing Type 1 or Type 2 Diabetes, Is the Eversense Device Right for You?
The approval illustrates how technology is rapidly changing the management of diabetes, says Ronnie Aronson, MD, an endocrinologist and the chief medical officer of LMC Diabetes and Endocrinology in Toronto, who has also studied continuous glucose monitoring. “This device is best suited for anyone trying to achieve optimal glucose control,” he says. “I think that this type of implant sensor is going to be the way of the future. I don’t think a decade from now we’ll still be applying patches to the skin to monitor glucose.” The technology is driven by the desire to make diabetes management easier and thus more effective, says Tim Goodnow, the president and chief executive officer of Senseonics. He says the device is best suited for people with type 1 diabetes and people with advanced type 2 diabetes who are dependent on insulin. “The attribute our patients are finding most attractive comes from long-term wear,” he says. “This is an opportunity to put it in and forget about it. The key aspect when managing diabetes is you’d like to make it as invisible as possible.” RELATED: Insulin for Type 2 Diabetes: When, Why, and How It’s important for people with diabetes to have choices in how they manage the disease, says Carol Levy, MD, a professor of endocrinology, diabetes, and bone disease at the Mount Sinai Diabetes Center in New York City, who was an investigator on a key clinical trial of the Eversense device. “This isn’t a one-size-fits-all disease,” she says. “We need to have options to meet each and every one of our patient’s needs. I think this provides a new option for a subset of people with diabetes.” The Eversense monitor may appeal to patients who have trouble remembering to change short-term glucose monitors, Klonoff says. “It depends on what’s important to you. There will be a market for a variety of these products.”
What Else to Know About the Newly Approved Implantable CGM
The clinical trial the approval was based on showed that the device read glucose levels with precision, Dr. Levy says. “This, like many of the newer sensors, has a pretty high level of accuracy.” Potential problems linked to the Eversense device include trouble with insertion or removal, such as allergic reactions to adhesives, bleeding, bruising, or infection, according to the FDA. There is a risk that blood sugar levels could plunge too low or rise too high if the device is inaccurate or the person wearing it misses alerts. But in studies, less than 1 percent of Eversense users experienced a serious adverse event. The FDA will continue to monitor the safety of the system in a post-approval study. RELATED: Doctors’ Group Issues New A1C Guidelines for People With Type 2 Diabetes The procedure to insert the device is performed in a doctor’s office and takes a few minutes. The need to return to the doctor’s office every 90 days to replace the sensor is unlikely to deter patients, Dr. Aronson says. “Patients have to travel to see the doctor that often anyway, so the frequency is not unusual,” Aronson says. In the coming months, endocrinologists will be required to learn the sensor insertion and replacement process. “It will be a new learning curve for us. But endocrinologists are excited to have this and offer it to our patients,” Levy says. People using the device will still need to take blood tests at home with finger sticks, Goodnow says. But future devices may eliminate the need for finger sticks. It’s not yet clear how much the device will cost, Goodnow says, adding that the company is working now with insurers to negotiate cost. In general, he says, continuous glucose monitors in the United States tend to cost insurers about $10 a day. The cost to patients will depend on their own insurance plans, deductibles, and copays. It may be several more months before patients can obtain information about cost and insurance reimbursement, he says.
What Other Advances in Diabetes Technology Lie Ahead?
Technical advances in diabetes care were a focus of the American Diabetes Association (ADA) Scientific Sessions meeting held June 22–26 in Orlando, Florida, with multiple presentations on emerging systems to ease management of the disease. Aronson presented data on an implanted continuous glucose monitoring system for adults and adolescents with type 1 diabetes, showing the system provided accurate measurements with no major side effects through 180 days of use. “The key finding on the efficacy is the remarkable accuracy throughout the 180 days,” he says. “There was no loss of accuracy as time went on.” Continuous glucose monitoring systems may be especially appealing to adolescents and young adults who are already tech-savvy, he says. Continuous glucose monitoring systems are also being combined in closed-loop systems that deliver insulin. Another study presented at the ADA meeting showed positive results for an implantable continuous glucose monitoring system for adults with type 1 diabetes. The Omnipod hybrid closed-loop system combines continuous glucose monitoring with a personalized algorithm to deliver insulin through the skin with a small pump. A small study by researchers at Stanford University in California showed the device delivered good glucose control in a five-day testing period. “The technology is here, and more and more companies will develop technologies,” Aronson says. “The future of diabetes is going to be largely tech-based.” An earlier version of this article incorrectly stated that the Eversense CGM is inserted under the skin on the arm or abdomen. It should have read that it is inserted only under the skin on the arm, not under the abdomen. Everyday Health regrets the error. For more on diabetes technology, check out Diabetes Daily’s article “How Smart Technology Is Changing Diabetes Care”!
