Cloud computing, intelligent sensors, apps, and diabetes monitoring come together with Senseonics’ Eversense PROMISE 180-day sensor clinical trial of Eversense® continuous glucose monitoring (CGM) system for diabetes. Senseonics achieved the major completion of patient enrollment study milestone.
The study is evaluating the safety and efficacy of the implantable CGM system for pre-market application submission to the U.S. Food and Drug Administration (FDA) reports Medical Device Network. The CGM system was approved in Europe. The goal of system use is to replace the fingerstick blood glucose (BG) measurements to make further decisions on diabetes management.
The PROMISE 180 study investigators are evaluating the accuracy of the Eversense 180 CGM System measurements when compared with reference standard measurements up to 180 days of sensor use. The investigation will also evaluate safety of the Eversense 180 CGM System usage.
Clinical Investigative Sites
With 181 participants, the study started late 2018 and will run through March 2020. Several clinical sites are participating and being led by Barbara Davis Center for Diabetes. Other sites include: John Muir Physician Clinical Research Center; AMCR Institute, Inc.; Diablo Clinical Research; Atlanta Diabetes Care; Rocky Mountain Diabetes Center; Clinical Trials of Texas; and Rainer Clinical Research Center.
What is Eversense 180 CGM System?
The Eversense 180 CGM System is, according to its’ maker Senseonics, “the world’s only long-term CGM system.” They declare on their website that Eversense 90-day CGM system helps diabetes actively management their diabetes “simply and with confidence.” It achieves this by continuously monitoring the patient’s blood glucose levels for up to 90 days via the under-the-skin sensor, which is a removable and rechargeable software-powered transmitter and an associated software application that powers real-time diabetes monitoring and management.
The system includes A) the Sensor; B) the Transmitter and C) the mobile app. The system is designed to use the internet to connect to a cloud-based application for continuous monitoring. All of these components work together to provide sensor glucose values, trends, and alerts to a user’s mobile device within 20 milliseconds. Ms. Katherine Tweden, the sponsor’s vice president of clinical sciences notes, “This is the first study in the U.S. in which study participants are implanted with a single sensor, which will produce accurate continuous glucose measurements for up to half a year.” Ms. Tweden commented “We expect to have the full data for analysis at the end of the first quarter of 2020 for submission to the FDA later that year.”
Eversense has inked a deal with Glooko, a diabetes data management platform, so that the two can connect Eversense CGM directly from the Senseonics Cloud.
Who is Senseonics?
Based in Germantown, MD, Senseonics is a medical device startup developing transformative glucose monitoring products intended to enable people with diabetes to confidently live their lives with ease the company reports on their LinkedIn description. They note that by utilizing breakthrough fluorescence sensing technology, the Senseonics continues glucose monitoring (“CGM) system is being designed to be the first fully implantable CGM that is highly accurate throughout its long sensor life.
Senseonics was founded in 1996 and went public in 2016. Trialsite News estimates their number of employees to be between 250 and 300. Their stock price is incredibly depressed as more investors have sold than bought. Why? It would appear that their anticipated market is not as robust as they would have liked but the U.S. study could change this.
Their current market capitalization is $191.6 million on projected $20.3 million in revenue, according to Yahoo Finance. The problem—their EBITDA projection is a loss of $114.4 million and they only have $65 million cash in the bank. As a publicly traded company, they have the ability to raise more capital than a privately held concern, but the numbers are challenging. The management believes there will be greater adoption of the system and, hence, drive the momentum positive moving forward.
This positive trend will be driven, if in fact it occurs, by a direct sales force the management is presently building. It consists of regional and district managers, medical educators, and a customer care organization to support the continued commercialization of the product in the United States to meet its target of an estimated 2,100 endocrinologist, active and diabetes-focused, in America. This sales force will be costly, but it is also the only real way for Senseonics to take destiny in their own hands and achieve break-even and thereafter, profitability.
Satish Garg, MD, Barbara Davis Center, University of Colorado, School of Medicine
Call to Action: If you or a loved one is a diabetic and interested in this approach to glucose monitoring, it might makes sense to monitor this study. TrialSite News will continue to watch for updates, and you can sign up with the newsletter to see these. For investors, this stock is incredibly cheap; however, it would appear to be very risky. Our real question: assuming the product works very well, what percentage of diabetics would be interested in switching from traditional glucose monitoring to have an implanted sensor and essentially be connected via internet to a cloud-based monitoring application? Possibly a lot, as this represents where health care is going—real time understanding of vital indicators.