Senseonics and Ascencia Diabetes Care Announce FDA Approval of the Eversense® E3 CGM System
The Eversense E3 CGM System offers patients:
- Fully implantable third-generation sensor, with proprietary SBA technology to enhance sensor longevity, demonstrating a mean absolute relative difference (MARD) of 8.5% in the PROMISE Study.
- Industry-leading 6 month sensor wear duration, making Eversense the longest-lasting CGM system available, with essentially two sensor insertion and removal procedures per year.
- Fewer calibrations are required by the user, with primarily one calibration required per day after day 21 of sensor wear.
- Removable smart transmitter, held in place with a mild silicone-based adhesive, provides discreet on-body vibratory alerts and data transmission to a mobile app where glucose values, trends, and alerts are displayed.
- The announced launch plan will begin starting in the second quarter of 2022 for U.S. clients.
Answers to questions on everyone’s mind about The Eversense E3 CGM System
While we will need to wait on the first 3 questions, we do have the answers to the last few questions!
- What will insurance coverage and out-of-pocket costs look like? https://www.ascensiadiabetes.com/eversense/eversense-access-cost/
- Who is/will be trained for sensor insertions and how do clients find trained providers?
- Will it link with my (any) pump?
- What age range is it approved for?
The Eversense E3 System is indicated for adults ages 18 and older with Type 1 or Type 2 Diabetes.
- What the heck is “proprietary SBA technology”???
Proprietary SBA technology is Senseonic’s special sauce. It is known that a variety of substances can interfere with sensor accuracy. This is less of an issue now than in the now distant past with Dexcom’s and Freestyle’s previous sensor versions). SBA stands for Sacrificial Boronic Acid (which sounds like a Doomsday weapon of some sort) is the ingredient added to the sensor that helps reduce the breakdown of the sensor components. SBA allows the sensor to remain more accurate over a longer period of time compared to an identical sensor without the special sauce, er, SBA.
- What’s in it for me?
> not losing data every 10-14 days compared to life with Dexcom or Freestyle sensors during new sensor warm-up is a big one!
> Great MARD (Mean Average Relative Difference = ACCURACY) and reliability (translation: works well, works consistently with less day-to-day variation than current 10 or 14-day wear sensors)
> Ability to get a vibration right on the skin from the transmitter for low/high glucose if you have your cell out of blue tooth signal range (i.e. you forget to charge your cell overnight and are currently asking a nearby office mate to borrow their charger).
> fewer calibrations are required than the prior, 90-day wear, version of Eversense.
> fewer pokes!
For additional reading about The Eversense E3 CGM System:
Eversense benefits (current, 90-day wear info is available online at this time): https://www.ascensiadiabetes.com/eversense/why-eversense-cgm/
For an IDS review on the prior version (90-day wear) see: https://integrateddiabetes.com/in-depth-review-of-senseonics-eversense-cgm-and-its-pros-cons/
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