The FDA has approved the Eversense glucose monitoring system. Experts say it’ll make life easier for people with diabetes, but there are some potential drawbacks.
As recently as the 1970s, people with diabetes used chemical-coated paper strips that were dipped in urine to measure their blood glucose levels at home.
The paper strips provided a blood glucose range hours later, making the information nearly useless.
Times have changed.
The U.S. Food and Drug Administration (FDA) recently
The Eversense Continuous Glucose Monitoring (CGM) system is manufactured by Senseonics. It’s approved for use in people 18 years or older with diabetes.
The sensor is implanted by a trained healthcare professional during a short outpatient visit and can be worn for up to 90 days.
The sensor that measures glucose sits just under the skin where it uses a unique “light-based” technology.
It sends glucose level data to an app on your cell phone, giving patients warnings if their glucose is rising too high or dropping too low.
In contrast to today’s current CGM technology, the Eversense’s 90-day sensor life is impressive.
Sensor technology from Dexcom and Medtronic is approved for use for up to 10 days, requiring patients to remove and reinsert a new sensor into subcutaneous tissue in another part of the body.
When a patient is also wearing an insulin pump, finding healed, available, and convenient “real estate” on their arms, thighs, and belly can lead to a great deal of scar tissue, especially when the patient needs to rotate a CGM sensor.
The 90-day life of the Eversense means far less scar tissue and far less weekly maintenance for a patient’s overall diabetes care.
However, the “fully implantable” sensor should not mislead patients into thinking there is no external aspect to this technology.
Like other CGM sensors, a transmitter is essential to actually receive and send the blood glucose data. The Eversense transmitter is black and a bit larger than the face of an Apple Watch.
It’s also water-resistant for up to 30 minutes when submerged.
The transmitter can be removed temporarily without disrupting the sensor underneath the surface of the skin.
Like the Dexcom and Medtronic sensor technology, the Eversense system does send blood glucose data every 5 minutes to a mobile app on Apple phones.
If the phone is out of range, the transmitter will vibrate to indicate low and high levels.
Additionally, the mobile app allows users to track their food, exercise, and medications.
There are some potential drawbacks to the new technology.
However, Scheiner’s experience in bringing innovative diabetes technology into the real world with his patients means he knows how significant even the minor details can be for daily blood glucose management.
“On the plus side, it has very good accuracy (similar to Dexcom), the sensor lasts three months, and it already links to a nice phone app,” Scheiner told Healthline. “On the downside, you still have to tape a transmitter to your skin and charge it periodically. Plus, the sensor insertion (and removal) requires an in-office procedure and it doesn’t link with any hybrid closed loop systems.”
This in-office visit every three months for a new sensor could be an obstacle for some people.
Dexcom and Medtronic sensors are applied every week or so by the patient, in their own home, within a matter of minutes.
Having to schedule an appointment, trek to the hospital, sit in the waiting room, and spend 15 minutes getting a new sensor applied is time-consuming compared to other CGM technology.
As far as accuracy is concerned, the FDA reports having evaluated the Eversense CGM technology in 125 individuals ages 18 and older with diabetes.
FDA officials compared blood glucose readings to laboratory-based tests.
They said the Eversense system met all accuracy standards of today’s current CGM and glucometer technology.
The safety of the device is also an aspect of its accuracy capabilities.
An inaccurate blood glucose level report could cause a patient to take unneeded insulin, which could result in severely low blood sugar.
“During these studies,” explains a press release from the study, “the proportion of individuals experiencing a serious adverse event with the implanted sensor was less than 1 percent.”
Other potential side effects of using the system are largely skin-related.
The insertion, removal, and wearing of the sensor can cause bruising, allergic reaction, bleeding, infection, pain, scarring, inflammation, and discoloration.
These skin-related side effects are, however, things most patients taking insulin already endure on a regular basis with current Dexcom and Medtronic CGMs as well as with insulin injections and insulin pumps. They all simply come with the territory of managing diabetes.
Studies to further demonstrate the safety of the Eversense CGM will continue to take place.
“The FDA held an advisory committee meeting to provide an independent assessment of the safety and effectiveness of the Eversense CGM system,” explains the press release.
The committee voted that the benefits of the system for people with diabetes outweigh any of the minimal risks.
The technology will be just as costly — even with health insurance — as Dexcom or Medtronic’s CGM technology.
Patients in the United States are paying thousands of dollars every year for even the most basic costs of insulin and glucose strips to stay alive.
Some are expressing frustration at the rising costs of living with disease that is fully covered in other countries, such as the United Kingdom.
The Eversense technology could be life-changing for many patients, but without health insurance and approval to help cover its costs, it will be an out-of-reach pursuit for many.
“Clearly, it’s not for everyone,” says Scheiner, “but I think it will meet the needs of certain people — especially those who don’t want to be bothered with weekly sensor change-outs.”