Silver Spring, Maryland, USA: The U.S. Food and Drug Administration approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes, on Thursday. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.
“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” said FDA Commissioner Scott Gottlieb, M.D. “These technologies allow patients to gain better control over their health. This approval of a more seamless digital system that gives patients the ability to effectively manage a chronic disease like diabetes is a vivid illustration of the potential for these mobile platforms. The FDA is creating a new and more carefully tailored regulatory approach for software products, including mobile medical apps, that will enable efficient oversight of these digital technologies and maintain FDA’s gold standard for product review. We’re advancing a more modern approach for these products that’s carefully adapted to the unique characteristics of these opportunities.”
People with diabetes either do not make enough insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes). When the body does not have enough insulin, or cannot use it effectively, sugar builds up in the blood. High blood sugar levels can lead to heart disease, stroke, blindness, kidney failure and amputation of toes, feet or legs. Individuals living with diabetes must regularly monitor their glucose levels as part of the management of the disease. This includes making sure that diabetes management accessories, like most current glucose sensors, are replaced on a regular basis (generally, every seven days) to ensure that an overall CGM system is properly functioning.
The Eversense CGM system uses a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure. After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days. The implanted sensor works with a novel light-based technology to measure glucose levels and send information to a mobile app to alert users if glucose levels are too high (hyperglycemia) or too low (hypoglycemia). The sensor is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that is measured by the sensor. Every five minutes, measurements are sent to a compatible mobile device (e.g., smart phone or tablet) that is running a device-specific mobile app.
The FDA evaluated clinical study data from 125 individuals aged 18 and older with diabetes and reviewed the device’s effectiveness by comparing readings obtained by the Eversense CGM system to those obtained by a laboratory-based glucose analyzer. The safety of the Eversense CGM system’s 90-day implantable sensor, and the procedure used to implant it, was also evaluated during the clinical studies. During these studies, the proportion of individuals experiencing a serious adverse event with the implanted sensor was less than 1 percent. The safety of this novel system will also be evaluated in a post-approval study. The FDA held an Advisory Committee meeting to provide an independent assessment of the safety and effectiveness of the Eversense CGM system. In an 8 to 0 vote, the committee recommended that the benefits of the Eversense CGM system outweigh the risks for patients with diabetes.
Potential adverse effects related to insertion, removal and wear of the sensor include allergic reaction to adhesives, bleeding, bruising, infection, pain or discomfort, scarring or skin discoloration, sensor fracture during removal, skin inflammation, thinning, discoloration or redness. Other risks associated with use of the CGM system may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate or where alerts are missed.
The FDA granted approval of the Eversense Continuous Glucose Monitoring System to Senseonics, Inc.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The company has been waiting on this clearance since November 2016. It’s very significant for the company, which is already selling its second-generation device in Europe, the Middle East, and Africa.
“We actually have been commercializing the product for about 21 months in Europe, so we’ve got some experience with our manufacturing, our quality systems, and we do that predominately through our partner Roche,” Senseonics President and CEO Tim Goodnow told reporters. “And now the US is our largest market. It’s about 75 to 80 percent of the global glucose monitoring market opportunity for CGM, and we’re happy to be here.”
Goodnow says the approval took a little while because the implantable CGM is novel and the FDA elected to convene a panel meeting of medical experts.
“They requested that because they had never approved an implantable product before for glucose monitoring. So [they held the panel] to make sure that they asked all the right questions and that they had representatives from the medical community to buy-in on their decisions,” Goodnow said. “And I think that really empowered the FDA to feel strongly about moving quickly to that final approval.”
The new clearance is for an older Senseonics device. It covers the 90-day monitoring model, whereas the version on sale in Europe lasts for 180 days.
“We are out with the 180-day product in Europe and we will be bringing it to the United States,” Goodnow said. “But [the 90-day device] is a very attractive and compelling product for people with diabetes.”
Additionally, since Senseonics submitted its application prior to Dexcom’s landmark clearance for non-adjunctive use, Eversense is not currently cleared for use without a fingerstick glucometer.
Both of these are likely temporary situations: now that Senseonics has its first clearance, both non-adjunctive and longer-life models should move through the agency more quickly.
“When the Dexcom decision came forward we met with the FDA and they said we’re certainly free and able,” Goodnow said. “But unfortunately it’s that they would consider a material change so they would have to reset the clock. And we said, we don’t want to do that. We’ll submit for that dosing claim as a supplement right after we get approval.”
Unlike in Europe, where Senseonics has commercialized its devices through a partnership with Roche, in the United States it will sell directly to endocrinologists.
“Roche is a great distribution partner in Europe, but we will be distributing it ourselves in the United States,” Goodnow said. “There’s 2,000 doctors to call on, high quality sales reps can cover about 20, so we need about 100 to cover that space. And 100 is a small enough sales force that a company like Senseonics can handle it.”
He says the company expects to have the first device in patients’ hands by the end of July.