Eversense receives FDA approval

June 21, 2018

The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. 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.


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If only Medicare would pay for it

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I’m a bit conflicted about this product. I can see great advantages to it. Just think no more adhesion problems. No more waiting for the next package of sensor to arrive, all that’s needed it a scheduled quarterly visit to the doctor, something many do already. No more inserters to deal with. No more over taping and no more defective sensors(I would hope).

Of course there is the big down side. Insertion becomes a surgical procedure and of course what is inserted surgically must be removed surgically. Time might not be a big problem if it lasted more than 3 months but that seems too often

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@Stemwinder_Gary When I spoke with one of the marketing VP talking heads earlier this year, they wanted to start with the 90 day product to get the FDA to clear it. Ultimately, their goal is to release the 6 month version that is being used in Europe now as the Eversense XL.

I personally am willing to try it.

I hope they get the 180 day product out in the US and its accuracy holds as steady as the 90 day product. Going in 4x a year to replace the sensor is doable but twice a year would be a very nice change vs every 7-10 days with dexcom, esp if as Gary suggested, you can have it replaced at your usual checkup anyway. Nice bonus to not worry when you accidentally knock the transmitter off since you can just tape it back on

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How much does it cost atm ? and does anybody know if it’s available in australia ?

I am very excited about this product. Agree 2x a year would be great. It sounds like an easy insertion process by the medical staff. I would love to not have to worry about knocking my sensor out and would love being able to remove the transmitter when ever I wanted. Plus if on arm you could could use all different types of tapes or even bands to hold the transmitter on and really have a way to deal with tape sensitivities. Once it is approved by insurance for a 180 day device i will be looking at switching.

I bet Medicare starts covering pretty quickly. This would be an ideal device to use in nursing and long term care facilities. Plus it is ideal for older people that have trouble with inserting the current devices.

My wife has Libre - I was working on switching to Dex - paperwork is in but I put them off until I find out if ES is working on medicare approval - I submitted the question 3 times from their website where it states they get back within two days - I finally sent an email to support stating if they can’t do what they say then take it off their website - I told them they lose credibility and that it brings into question what else they misrepresent. Then I got a blah blah blah load of nonsense how I should send my phone # and they will call in person. Of course they have to be working on it, but I just wanted to hear it. Would have taken them all of 3 seconds to type yes and hit send.

What Gary said.

From what I can tell, you still need to adhere a transmitter to your arm and try to keep it there. To me, getting a surgical procedure every 3 months coupled with wearing a transmitter (which doesn’t look very small by the way) is way more hassle then just applying a normal CGM every 10 days. Plus, have you ever seen the video of the insertion procedure?!? Yikes! Does NOT look very fun to me…


The size is 37/48/8 MM

Absolutely shaking my head why anyone would prefer screwing with sensors and transmitters every 7 days rather then have a painless 5 minute procedure.
The transmitter is not that much bigger then the Libre sensor.
I guess that is why restaurants have menus.

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