NEWS Health News FDA Approves Longest Lasting Continuous Glucose Monitor for Diabetes By Claire Wolters Claire Wolters Twitter Claire Wolters is a Philly-based reporter covering health news for Verywell. Learn about our editorial process Published on February 22, 2022 Fact checked Verywell Health content is rigorously reviewed by a team of qualified and experienced fact checkers. Fact checkers review articles for factual accuracy, relevance, and timeliness. We rely on the most current and reputable sources, which are cited in the text and listed at the bottom of each article. Content is fact checked after it has been edited and before publication. Learn more. by Heather Mercer Fact checked by Heather Mercer Heather Mercer is native to Northwest Ohio (go Walleye!) and graduated from Loma Linda University with two doctorate degrees (psychology and public health). She is currently a professor at Owens Community College, as well as a fact-checker for Verywell Health. She has gained experience in a variety of settings, ranging from corporate wellness and preventive medicine, to mental health, chronic disease, and end-of-life care. Learn about our editorial process Share Tweet Email Print Senseonics Key Takeaways The FDA approved a continuous glucose monitor (CGM) that lasts up to six months.The system, Eversense E3, is now the longest lasting CGM in the world.CGMs help people track blood sugar levels and manage their diabetes. The U.S. Food and Drug Administration (FDA), in February 2022, approved a new continuous glucose monitor (CGM) for diabetes with a sensor that can last for up to six months. Known as the Eversense E3 System, the device is now the longest lasting CGM approved in the United States and the world. It is expected to be available for adult patients this spring 2022. Previously, the longest approved sensor lasted for 90 days. This was also an Eversense product, and was approved in 2018. What is a CGM? CGMs track blood sugar levels and trends in people with type 1 and type 2 diabetes to help people make informed decisions about their diet and lifestyle. Monitors track this information 24/7 (hint: continuous) and many provide updates to their wearer every five minutes. Continuous Glucose Monitoring: Weighing the Pros and Cons “Further extending the duration of the longest lasting CGM system to six months represents a massive leap forward for patients and towards our mission of transforming lives in the global diabetes community,” Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics, said in a press release. Goodnow added that the product’s review was delayed a year due to the pandemic, and that the current launch will help establish a foundation for growth. How Long Do Most CGM Sensors Last? Depending on what brand a person has, a CGM sensor can be changed at home or in a doctor's office. A sensor that can be changed at home will typically last between one and two weeks. Devices that require a doctor’s visit for changing may only need to be changed a handful of times a year, according to the Cleveland Clinic. Changing out the sensors in an Eversense E3 requires a procedure, so a patient should schedule a doctor's appointment when their six months are up. How Does The Eversense E3 Work? In addition to the CGM sensor, which rests under the skin and requires a procedure to put in and take out, the Eversense E3 contains a removable smart transmitter, which is attached to the body with silicon adhesive. While the sensor collects data, the transmitter interprets it and displays it to the wearer. It does this by providing vibrations and smartphone alerts with sugar levels and trends. CGMs are more helpful for people with type 1 diabetes, who cannot make insulin on their own and need frequent data on their levels in order to know how many insulin injections, or pumps, to give themselves, according to Kaiser Health News. They are less helpful—and perhaps needlessly expensive—for people with type 2 diabetes, who can make insulin on their own and respond less severely to level changes than people with type 1. People who use CGMs do not have to prick their finger before each reading, but may still need to administer a prick once or twice a day to calibrate the device. Is It Affordable? CGMs are generally expensive, especially for people paying out of pocket, and costs can reach thousands of dollars a year. Still, several private insurance companies and Medicare will cover CGM for some patients. Walmart Is Offering a More Affordable Brand of Insulin People who pay out-of-pocket for an Eversense E3 may be eligible for financial assistance through Ascensia Diabetes Care (ADC), which will pay up to $300 of the balance of costs, or up to $1,200 a year. Medicare may cover Eversense E3 for people with diabetes, who take insulin at least three times a day (or use an insulin pump), test their blood glucose at least four times daily, and have a doctor’s appointment every six months. Prior to its approval, the device was studied for its accuracy and safety in a study called the PROMISE study, which found the device to be accurate and safe for up to 180 days and an improvement from past options. “We repeatedly hear from our patients with diabetes that what they desire is a long-lasting sensor that is also highly accurate,” Satish Garg, MD, principal investigator of the study said in the press release. “This is another step forward for patients who desire to manage their diabetes with all the advantages of the Eversense CGM with the fully implantable sensor.” What This Means For You The FDA approved the longest lasting continuous glucose monitor (CGM) for people with diabetes. The device helps people track blood sugar levels and manage their diabetes and only needs to be changed twice a year. But for people without insurance coverage, it may be hard to afford. Was this page helpful? Thanks for your feedback! Sign up for our Health Tip of the Day newsletter, and receive daily tips that will help you live your healthiest life. Sign Up You're in! Thank you, {{form.email}}, for signing up. There was an error. Please try again. What are your concerns? Other Inaccurate Hard to Understand Submit 5 Sources Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy. Senseonics. Senseonics announces FDA approval of the Eversense® E3 Continuous Glucose Monitoring System for use for up to 6 months; Provides 2022 business outlook. U.S. Food and Drug Administration. FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes. FDA News Release. Published June 21, 2018. PRNewswire. Ascensia Diabetes Care announces FDA approval of the Eversense E3 Continuous Glucose Monitoring system for use for up to 6 months. Galewitz P. ‘Painless’ glucose monitors pushed despite little evidence they help most diabetes patients. Kaiser Health News. Published March 16, 2021. Garg SK, Liljenquist D, Bode B, et al. Evaluation of accuracy and safety of the next-generation up to 180-day long-term implantable Eversense Continuous Glucose Monitoring System: The PROMISE study. Diabetes Technology & Therapeutics. 2022;24(2):84-92. doi:10.1089/dia.2021.0182