Thursday, December 1, 2022

Dr. Francine Kaufman: Eversense E3: A New Long-term CGM System for Diabetes Management

Over one in ten people in the U.S. live with diabetes, a total of 37.3 million people[1]. And whilst the past decades have seen the incidence of diabetes rise globally, the technology available to manage it has also come along in leaps and bounds.

This year marks 100 years since insulin was first successfully used as a treatment for diabetes, and this anniversary is a good time to reflect on the vast amount of progress that has been made in technology and management options. People living with diabetes now have more choices and are able to manage their condition in far less intrusive and disruptive ways than were previously possible.

Healthcare providers are able to offer a wider range of options to patients than ever before, and continuous glucose monitoring systems (CGMs) have rapidly established themselves as the gold standard of care for measuring glucose levels. One of these CGM systems is the next-generation Eversense® E3 from Senseonics, which was approved by the US Food and Drug Administration earlier this year and is the longest-lasting CGM system available in the U.S.

Building a system that helps people living with diabetes break free

Senseonics’ aim with the Eversense E3 System was to be deeply responsive to the needs of people living with diabetes and design a product with a focus on patient freedom. For some patients using traditional transcutaneous CGM, technology issues can impact adoption and adherence[2], making it vital to address their concerns and continuously improve CGM systems. Fundamentally, people living with diabetes want the choice, functionality and interoperability that allows them to seamlessly integrate technology to meet the unique needs of their condition.

We set out to address the key improvements which we repeatedly heard requested by people who manage their diabetes using CGMs. These are three-fold: longer sensor wear, better accuracy and a better sensor adhesive.

Brought to people with diabetes by our partner Ascensia Diabetes Care, the Eversense E3 CGM System is unique as the longest-lasting CGM system available in the U.S. It can be used continuously for up to six months, meaning that essentially only two sensor insertions and removals are required per year, compared to between 26 and 52 a year for other systems. This means that patients are able to break free from the burden of weekly or bi-weekly sensor changes, inconvenient self-insertions and the constant reordering of supplies. Thanks to a proprietary sacrificial boric acid (SBA) design modification, it maintains exceptional accuracy over the six-month period, with an overall MARD of 8.5%, as determined by the PROMISE Study[3].

For clinical benefit to be felt, a CGM system needs to be worn more than 70% of the time[4] and due to its unique design, the median wear time of the Eversense  captured in the real-world analysis was84.1%[5], which is well over this threshold. One contributing factor to this is its gentle silicone-based adhesive, which is formulated to reduce the likelihood of skin reactions, as well as to allow easy application and removal of the smart Transmitter to fit around patients’ lifestyle*. Whether it’s to take a shower, hit the gym or to play with the kids, the transmitter can be temporarily removed and then replaced without disrupting the implanted sensor. Whilst healthcare practitioners must encourage people with diabetes to wear their CGMs for as much of the time as possible, this feature provides unparalleled flexibility and freedom.

CGM system with a fluorescence sensor and on-body vibratory alerts

The Eversense E3 provides patients with everything they need to monitor and respond to their sugar levels. There are three parts to the product: a fully implanted sensor, a smart transmitter, and a mobile phone app.

Inserted in a minor procedure, the sensor is tiny – approximately 3mm by 18mm – and reads interstitial glucose levels, like other CGM sensors. Unlike other sensors, however, the Eversense E3 uses fluorescence rather than enzymatic technology. For the first 21 days, the system must be calibrated using fingerstick blood glucose measurements twice a day, but for the remainder of the six-month wear time, calibration is  required primarily once a day – ensuring the accuracy needed to manage diabetes with confidence.

The sensor is powered through near field energy by the transmitter, placed over it using a mild silicone-based adhesive, which is reapplied daily. Uniquely, the transmitter produces on-body vibratory alerts. Vibrations inform users when their blood sugar levels are high or low, meaning that they are free from having to be within reach or earshot of their phone at all times. This feature is particularly useful for physically strenuous jobs or highly active lifestyles but, more generally, helps the Eversense E3 to integrate as seamlessly as possible into people’s daily routines.

The third and final part of the Eversense E3 is the mobile app. Glucose data is refreshed via Bluetooth every five minutes and enables people to track trends and patterns. It provides auditory and visual alerts to warn users of potential upcoming hypo- and hyperglycaemic events, equipping them to respond rapidly and effectively to stabilise their glucose levels.

The Eversense E3 is also compatible with Eversense NOW, which allows users to remotely share their glucose data with up to five other people. Keeping friends and family in the loop is an important part of long-term diabetes management; people with strong support networks feel more able to manage their condition, and Eversense NOW seeks to further facilitate this working in tandem with the Eversense E3. Overall, the system provides people with diabetes with a highly accurate, easy-to-use, long-term solution to blood glucose monitoring.

Providing the Eversense E3 as a healthcare practitioner

The Eversense E3 was recently granted FDA approval in the U.S. and it is planned that healthcare practitioners will be able to offer the system to patients from the second quarter of this year. Training and certification is provided by Senseonics, which will provide the training and tools necessary to insert and remove the sensor. This is a simple in-office procedure, requiring a small 5mm incision and lasting 15 minutes from start to finish. Physicians, endocrinologists, nurse practitioners and physician assistants are all eligible for training and certification. The Eversense E3 and the insertion and removal procedures are well-covered by medical insurance through Senseonics’ distribution partner, Ascensia Diabetes Care. Healthcare practitioners who are interested in becoming registered providers can sign up at https://www.ascensiadiabetes.com/eversense/become-a-provider/register/, or contact 844-SENSE4U (844-736-7348) to find out more.

Editor’s Note: About Dr. Francine Kaufman

Dr. Kaufman is a world-renowned endocrinologist who has served as president of the American Diabetes Association and chaired the National Diabetes Education Program. Alongside her position as Distinguished Professor Emerita of Pediatrics and Communications at the University of Southern California, she has been a practicing physician for almost 45 years. She joined the team at Senseonics in 2019 as the Chief Medical Officer.

©2022 Ascensia Diabetes Care Holdings AG. All right reserved. Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.

[1] https://www.cdc.gov/diabetes/data/statistics-report/index.html

[2] Engler R, et al. (2017). Adoption barriers for continuous glucose monitoring and their potential reduction with a fully implanted system: Results from patient preference surveys. Clinical Diabetes, 36(1), 50-58. doi: 10.2337/cd17-0053.

[3] Garg S. et al. Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study. Diabetes Technology & Therapeutics 2021; 24(2): 1-9.DOI: 10.1089/dia.2021.0182

[4] Battelino T, et al. (2019). Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From The International Consensus on Time in Range. Diabetes Care 2019(42), 1595-1597. doi: 10.2337/dci19-0028.

[5] Tweden, K. S. et al. Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucosem Sensor Insertion and Remobal Cycles. Diabetes Technology & Therapeutics, 22(5), 422-427. https://dol.org/10.1089/ dia.2019.0342.

* There is no glucose data generated when the transmitter is removed

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