The lifestyle and physical well-being of a number of Type 1 and Type 2 diabetics appears to have received a significant boost, according to experts. That’s because the FDA recently approval of the use of the Eversense Continuous Glucose Monitoring (CGM) system for patients 18 years or older.
The device is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose levels, which can be worn for up to 90 days. The sensor is implanted just under the skin during an outpatient procedure. In July, the company that developed the CGM reported that it expects it to ship in the next few weeks.
Diabetics, of course, either don’t make enough insulin (Type 1 diabetes) or can’t use insulin properly (Type 2). In either case, sugar accumulates in the blood, potentially leading to issues like heart disease, stroke, blindness, and kidney failure. To control their condition, diabetics need to regularly monitor their glucose levels, a regimen that includes replacing their glucose sensors about every week.
"The FDA’s committed to advancing novel products that leverage digital technology to improve patient care," FDA Commissioner Scott Gottlieb, MD, said in a statement. "These technologies allow patients to gain better control over their health.”
The FDA evaluated clinical study data from 125 individuals ages 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.
Doctors weigh in
Kathleen Wyne, MD, an endocrinologist at The Ohio State University Wexner Medical Center in Columbus, Ohio, says the implantation aspect of the device will significantly expand the use of continuous glucose monitors. “The more information we have about sugar, the better people do, the better their A1Cs, the less variability they experience.”
While calling the device a significant stride, Harmeet Narula, MD, an endocrinologist at Banner Health in Sun City West, Arizona, says it’s too early to tell if this particular CGM—especially in its current iteration—is a dramatic step up over existing CGM systems. “Likely future versions would be more powerful.” Despite it being a relatively minor surgical procedure, some patients might hesitate to have the CGM implanted, noted endocrinologist Natasa Janicic, MD, associate professor of Medicine. division of Endocrinology and Metabolism at MedStar Georgetown University in Washington.
Wyne says the device will help engage physicians in using CGM. “A lot of them are excited there’s now a device that they actually get to put it in and take out.” With a patient able to continuously monitor their sugar and whether they’ve improved compliance and adherence, the downstream benefit, she adds, will be reduced cost.
“I think if we can increase the number of people using CGM and engage more patients, we can actually decrease long-term costs,” says Wyne. “It's helping us to understand what happens over the whole 24 hours of the day but also it gives us a chance to understand how yesterday impacted my sugars today.”
It’s an exciting times to be a consumer and provider in the diabetes space, says Harmeet, and there’s more promise on the horizon. “This is version 1.0; I look forward to 2.0 and beyond.”