Key Takeaways
The Food and Drug Administration (FDA) hasclearedSenseonics’ Eversense 365, the latest implantablecontinuous glucose monitoring (CGM)system for adults with diabetes that can last up to a year. The previous monitor, Eversense E3, couldlast up to six months without replacement.
The Eversense 365 implant features a small sensor, about the size of a grain of rice, that is inserted under the skin of the upper arm. The sensor sends blood sugar readings every five minutes to a mobile app, allowing patients to monitor their levels in real-time.
“The approval of Eversense 365 represents a significant leap in CGM innovation. Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes,”Tim Goodnow, PhD, president and chief executive officer of Senseonics, said in astatement.
Here’s what else you need to know about how CGMs work, potential risks, and where to get it.
How Does Eversense 365 Work?
A certified healthcare provider can insert the Eversense 365 sensor during a quick in-office procedure that takes around five minutes, according toBrian Hansen, president of CGM at Ascensia Diabetes Care.
Once it’s in place, the sensor can monitor your glucose levels for up to a year with minimal interruptions, unlike many other devices that need to be replaced more frequently.
Fingerstickmeasurements are still required for calibration, but the Eversense system only requires this once a week after the initial two weeks (day 13), making it convenient for users and allowing them to have confidence in their glucose readings, Hansen added.
“Its unique, fully implantable design helps people to overcome common frustrations experienced with traditional short-term CGMs, such as not lasting their indicated wear time, getting knocked off, skin irritation from harsh adhesives, and false alerts at night,” Hansen said.
Eversense 365 also features a removable transmitter that can be taken off when you don’t need glucose data updates, Hansen explained. “The transmitter is placed over the sensor on the upper arm with a gentle, silicone-based adhesive that is changed daily, meaning that users experience maximum comfort and almost no skin reactions,” he said.
The older model, Eversense E3, will remain available to certain individuals in the United States, according to Hansen. “Both systems are fully implantable, long-term CGMs that support people with diabetes to live life uninterrupted,” he said.
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How Accurate Is the Eversense CGM?
Onestudyon the safety and accuracy of the Eversense CGM System found the sensor lasted 97% of the time over 365 days, and it was safe with only a few minor skin irritation issues reported.
Another study found that the Eversense CGM system provided accurate glucose readings throughout its intended 90-day sensor life while maintaining a positive safety profile for patients with type 1 and type 2 diabetes.
Do You Need to Do Fingersticks If You Use a CGM?
Even with a CGM device, patients should always have a backup method for measuring their blood sugar levels, according toPouya Shafipour, MD, a board-certified family and obesity medicine physician at Providence Saint John’s Health Center in Santa Monica, CA.
For non-diabetics and even those with prediabetes, fingersticks aren’t required. However, users should avoid taking CGM readings as absolute truth, he added.
“Based on my experience, there can be errors with these, so people should be coached to understand that the numbers might not always be 100% accurate,” Shafipour said.
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What Are the Risks of Implantable CGMs?
While CGMs can offer many benefits, they could cause skin irritation or infections at the sensor insertion site, Shafipour said. There’s also a slight risk that the body may reject the device, but such cases are rare.
CGMs may also provide inaccurate readings because of fluctuating body temperature or interference from certain medications, food, and supplements.
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When Will the Eversense 365 CGM Be Availabe?
The developers plan to launch Eversense 365 in the U.S. soon, with shipping expected to start before the end of October. Hansen said patients interested in the device can pre-register on theirwebsite.
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What This Means For YouIf you have diabetes and rely on continuous glucose monitoring, the Eversense 365 could offer a more convenient option. It can last up to a year without replacement and requires fewer fingerstick calibrations. The device’s long lifespan and real-time data could make managing your blood sugar levels easier and more reliable.
What This Means For You
If you have diabetes and rely on continuous glucose monitoring, the Eversense 365 could offer a more convenient option. It can last up to a year without replacement and requires fewer fingerstick calibrations. The device’s long lifespan and real-time data could make managing your blood sugar levels easier and more reliable.
1 SourceVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Christiansen MP, Klaff LJ, Brazg R, et al.A prospective multicenter evaluation of the accuracy of a novel implanted continuous glucose sensor: PRECISE II.Diabetes Technol Ther. 2018;20(3):197-206. doi:10.1089/dia.2017.0142
1 Source
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Christiansen MP, Klaff LJ, Brazg R, et al.A prospective multicenter evaluation of the accuracy of a novel implanted continuous glucose sensor: PRECISE II.Diabetes Technol Ther. 2018;20(3):197-206. doi:10.1089/dia.2017.0142
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
Christiansen MP, Klaff LJ, Brazg R, et al.A prospective multicenter evaluation of the accuracy of a novel implanted continuous glucose sensor: PRECISE II.Diabetes Technol Ther. 2018;20(3):197-206. doi:10.1089/dia.2017.0142
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