The Senseonics Eversense CGM could Surprise & Delight Users
Senseonics got FDA approval for its implantable Eversense CGM system; it was approved earlier in Europe and has more than 2000 patients there
The Eversense CGM system consists of an implanted sensor, a removable transmitter, and a smartphone app.
CGM adoption has been slower than expected with less than 30% of T1D people using CGM devices even though they have been available for a decade. Perhaps the biggest issue is that adherence and persistent use are disappointing among people once they buy a CGM. Industry reports say nearly 40% of people are not using their CGM devices consistently after 6 months and nearly 30% discontinue using their GCM altogether after a year.
We connected with Tim Goodnow, President & CEO of Senseonics, Inc., and exchanged questions and answers about the Eversense CGM.
Q: Will the Eversense CGM increase CGM Adoption?
We believe the features of the Eversense CGM will increase the rate of CGM adoption. The primary reason for this is our implantable sensor that encourages long-term wear of the Eversense system.
Doctors really want people to use CGMs and see the value in doing a procedure that encourages long-term wear of the system.
Users in Europe say that the removable transmitter avoids skin irritation and its unique vibration alerts provide extra safely compared to traditional CGM systems. They also value the discretion of checking their BG on their smartphone or watch.
Q: Is the Insertion of the Sensor painful and does it leave a scar?
Insertion is a 15-minute procedure that starts with a shot of Lidocaine, which is the most painful part of the procedure. The 5mm incision (about ¼-inch) is so small that it is closed with adhesive strips – no stitches are required. After the sensor is removed the incision may be red for a week or so but it does not leave a scar
We are finding that patients are actually relieved to have their physician do the insertion of the sensor. It alleviates the patients from having to do weekly or bi-weekly self-insertions. The users really enjoy having the sensor placed and not having to interact with it, no taping, no over-bandaging. This is much simpler than what they are used to. This is a different approach than other CGMs in the market and our goal is to ensure that the insertion remains very easy, efficient and convenient for both the patient and the doc. We understand that only by doing this will we be rewarded with patients and docs choosing Eversense to be part of their diabetes management.
Q: How are you educating the market about the insertion procedure?
We have many resources to help educate patients as well as physicians.
- Ever Mobile Clinic – our mobile clinic is currently touring the country to provide training for physicians, as well as education for patients during open houses. We have found that having patients and physicians see the procedure done on a prosthetic arm really helps demystify the sensor insertion process.
- Website – we have content, learning tools and videos explaining the procedure for patients and physicians.
- Clinical Trainers – we have certified clinical trainers across the country who will work with physicians to authorize them to perform the sensor placements for patients.
Q: How are you going to market the product?
The beauty of a long-term accurate CGM like Eversense is that it enables continuous use for 3 months – this is especially helpful for active patients and those actively managing their diabetes, whether they’re pumpers or on MDIs. As such, our focus is to reach out and create awareness with those people who will benefit the most.
We’re marketing Eversense with a multi-tiered approach focused on several audiences.
We’re focusing on the top 2000+ physicians across the US who are high-prescribers of rapid-acting insulin. By demonstrating the clinical accuracy and the benefits of a physician-placed CGM, we are confident that we will have significant physician adoption
In parallel to that, we’re also engaging with payers. Since CGM is covered by many plans in the US, we are happy that there’s not a need to convince the payers about the value of CGM. We do still need to have Eversense added to the CGM benefit of many plans and have the contracts and payments finalized.
Patients will play an important part in our success in the US. We’re already seeing early adoption of those patients who want the benefits of CGM, but do not want the pain and hassle of weekly or bi-weekly self-insertions. Currently, we have the Ever Mobile Clinic touring the US holding open houses for patients and physicians. Our clinical trainers who staff the mobile clinic demonstrate the sensor placement procedure and answer questions about the product, insurance and lifestyle questions about Eversense. We’ve seen such great responses from our patients once they can see first-hand how small the sensor is and learn more about the placement procedure.
Q: What effort will it take to convince existing CGM users to switch to Eversense?
Motivated patients who are tired of weekly and bi-weekly sensor insertions will not need much convincing. More importantly, those who are on CGM will see the value of long-term continuous glucose monitoring to help achieve or maintain their diabetes management goals while maintaining their active lifestyle. Besides the 3-month continuous use, the wearable transmitter can be taken off and on for those times you just don’t want anything on your body. The system can also alert you when you are low or about to go low – very useful especially during nighttime. You don’t have to carry a separate receiver as you use your own smartphone to see the results. And Eversense has outstanding accuracy with a MARD of 8.5% while providing the patient the freedom from self-insertions.
Editor Note: CGM accuracy is measured by MARD (Mean Absolute Relative Difference) from a patient’s reference values obtained from blood glucose measurements from a lab analyzer.
Q: What is your definition of success in terms of units sold within 2 years and % of the market?
There are a lot of people who could benefit from using Eversense CGM. We hope to both convert existing CGM users to the Eversense CGM and to expand the total number of people using CGMs so we help as many people as possible confidently live their lives by knowing their glucose levels.
Q: Do you plan to offer your sensor to other CGM providers?
No, not at this time. We are involved in several artificial pancreas studies, including the NIH-funded IDCL program with TypeZero (release) and, most recently, with Beta Bionics (website) artificial pancreas program. We’re focused on continuing to drive for advanced solutions for intensively managed patients with our long-term Eversense CGM System.
Q: What has user reaction been to your sensor in Europe where you have several years of deployment experience?
We currently have thousands of patients using Eversense XL in Europe and a consistent rate of reinsertion of the sensors. Once they try it, most patients don’t want to live without it.
Q: How does the accuracy of your sensor change over its 90-day design life?
The Eversense CGM demonstrates very high accuracy at 8.5% MARD which is highlighted in our approved labeling and was presented at this year’s American Diabetes Association annual scientific conference and American Association of Diabetes Educators conference (ADA presentation).
Q: Is your Fluorescent Polymer sensor technology more or less able, compared to Glucose/Oxidase sensors, to meet ISO expectations for higher accuracy?
We are very excited to see that our system performed at the best-in-class range of 8.5% MARD, which is lower than any of the Glucose Oxidase systems currently available from Medtronic, Dexcom, and Abbott. In addition, the Eversense CGM offers unique features that provide other benefits to patients, including long-term duration, exceptional accuracy, and convenience of the removable transmitter. Our published studies demonstrate outstanding accuracy over the life of the sensor. At the end of the day, it depends what ‘s best for the patient – the right product for the right patient at the right time.
Q: Do you see a practical way for sensor design life to be extended beyond 90 days?
We currently have a CE mark for the 180-day sensor in Europe – Eversense XL. To make this available in the US market, we are required to do a US-based clinical trial and we expect to start that this year. We are also actively doing research studies in Europe on our 365-day sensor.
Editor Note: CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area.
Q: What is the cost to payers for the procedure to insert/remove the sensor under the skin?
Each health plan and contract is different. We are currently working with payers across the U.S. to be added to their coverage for their members who have diabetes.
Q: How does your cost compare to traditional sensors with shorter design lives?
Our cost per day is comparable to other sensors in the U.S. market.
Q: Do you anticipate offering a self-calibrating sensor in the near future?
Our goal is to make the system as easy and convenient for users as possible and this includes reducing or eliminating calibration. The first FDA approval for the 90-day device has labeling requiring two fingerstick calibrations per day. We also have in our pipeline calibration reductions to be available for regulatory review and approval.
To ensure reliable and accurate readings through the 3-month life of the sensor, we have balanced the convenience of the long-term wear and accuracy with this first-generation sensor. The user can continuously wear the sensor and get accurate and reliable readings for 3 months without having to remove and re-insert the sensor every other week.
We do recognize that the market is certainly moving to eliminate calibrations. We’re going to do our best to head in that direction, as well.