Real-World Evidence of Eversense 365 Presented at ADA Demonstrating Strong Performance and Patient Impact in Both Open and Closed Loop Systems
Rhea-AI Summary
Senseonics (NASDAQ:SENS) reported new real-world evidence for its one-year implantable CGM, Eversense 365, presented at ADA 2026. The analysis covered 12,360 open-loop sensors and 153 twiist AID users.
According to Senseonics, Eversense 365 showed high adherence, stable one-year performance, and glucometrics at the upper range of reported real-world outcomes for both open and closed loop use.
AI-generated analysis. Not financial advice.
Positive
- Open-loop cohort of 12,360 Eversense 365 sensors analyzed in real-world use
- Average transmitter wear time of 93.19% across open-loop users
- Mean Time In Range of 66.16% and GMI of 7.16% in open-loop use
- More than 81% of users met hypoglycemic targets in open-loop regimens
- Comparable adherence and outcomes between first and second six-month periods
- Closed-loop twiist users reported mean TIR ~76.08% and GMI 6.78% after 30 days
- twiist users had median sensor wear time of 99.46%
- Reported performance within top end of published AID TIR and GMI ranges
Negative
- AID integration analysis based on only 153 sensors
- twiist AID outcomes reported after more than 30 days of use, indicating early-stage data
Key Figures
Market Reality Check
Peers on Argus
SENS fell 4.85% while key peers were mixed: BFLY (-10%), PACB (-9.37%), DCTH (-0.56%), RXST (-1.57%), and TCMD (+1.28%). With no peers in the momentum scanner and mixed moves, trading appeared more company-specific than a unified sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jun 01 | Conference preview | Positive | +0.7% | Preview of ADA 2026 analyst event and Eversense 365 data presentation. |
| May 07 | Earnings results | Positive | -6.2% | Q1 2026 revenue growth of 87% YoY and raised full‑year guidance. |
| May 04 | Equity offering | Negative | -0.2% | Closing of $92M public offering of shares and pre‑funded warrants. |
| May 04 | Debt amendment | Neutral | -1.8% | Loan amendment with Hercules increasing borrowing capacity to $140M. |
| May 01 | Earnings scheduling | Neutral | -22.8% | Announcement of Q1 2026 earnings release and conference call timing. |
Recent history shows several instances where positive or neutral developments were followed by share price declines, suggesting a tendency for weakness around news events.
Over the past months, Senseonics has combined clinical, commercial, and financing milestones. On May 4, 2026, it closed a $92.0M equity and pre‑funded warrant offering and amended a Hercules loan to expand borrowing capacity to $140M, supporting Eversense 365 development and pivotal trials. Q1 2026 results on May 7 showed revenue of $11.7M, up 87% YoY, with raised full‑year guidance to $60M–$64M. A June 1 ADA preview highlighted today’s real‑world Eversense 365 data, continuing the focus on the one‑year CGM platform.
Regulatory & Risk Context
The company has a Form S-3 universal shelf filed on 2025-08-06, allowing issuance of up to $300 million in securities, including a $100 million ATM program with TD Cowen. The shelf is marked as not yet effective and has been used in at least 2 424B5 takedowns in 2026, indicating capacity and prior utilization for capital raises.
Market Pulse Summary
This announcement highlights robust real‑world evidence for the one‑year Eversense 365 CGM, with high adherence, strong Time In Range, and favorable hypoglycemia metrics in both open and closed loop settings. Compared with earlier ADA‑preview communications and recent financing moves, it underscores a strategy of pairing capital access with expanding clinical validation. Investors may focus on how these outcomes support commercial momentum for Eversense 365 and future AID integrations, alongside existing funding capacity from the $300 million shelf registration.
Key Terms
continuous glucose monitoring medical
automated insulin delivery medical
glucose management indicator medical
hypoglycemic medical
AI-generated analysis. Not financial advice.
Eversense 365 delivered favorable glucometrics compared to other open and closed loop systems, validating the one-year CGM’s differentiated approach and high performance
New data expands on findings shared at ATTD and reinforces Eversense 365’s strong patient adherence, glucometrics and hypoglycemic outcomes across an entire year
GERMANTOWN, Md., June 06, 2026 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NASDAQ: SENS), a medical technology company focused on the development, manufacturing and commercialization of long-term, implantable Continuous Glucose Monitoring (CGM) Systems for people with diabetes, today announces further data from a large real-world evidence study which reveals sustained accuracy, performance and positive impact of Eversense 365 in both open-loop and closed-loop systems. The findings were presented during an oral presentation entitled ‘Real-World Evaluation of the Implantable One-Year Eversense 365 CGM System’ at the American Diabetes Association’s (ADA) 2026 Scientific Sessions, taking place on June 5-8 in New Orleans, U.S.
The data presented at ADA expands on the findings Senseonics previously shared at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) earlier this year, with a dataset including more sensors and users of Eversense 365, the first and only one year CGM- system. The presentation highlighted a real-world analysis of the first 12,360 Eversense 365 CGM sensors among open-loop users and an additional 153 closed-loop users, with the CGM used as part of the twiist™ Automated Insulin Delivery (AID) system for more than 30 days.
The extended dataset confirms the positive real-world impact of Eversense 365, with a full year of strong patient adherence, glucometrics and hypoglycemic outcomes. Importantly, the system delivered comparable adherence and outcomes between the first and second six-month period, indicating high accuracy and performance from a single sensor across an entire year. The presentation also highlighted strong glucometrics of the Eversense 365 and twiist combination, suggesting that the first ever AID integration with this unique CGM is having a meaningful clinical impact for people living with diabetes.
“This real-world data showcases the positive impact that Eversense 365 is bringing to patients, regardless of their preferred treatment plan,” said Francine Kaufman, M.D., Chief Medical Office at Senseonics. “The analysis shows Eversense 365 is delivering consistent and tangible benefits for people on either an open or closed loop system, giving patients and healthcare providers more choice and more confidence when using our differentiated CGM. This is vital because everyone’s experience with diabetes is different. Eversense 365 performs exceptionally well over an extended period and data suggests its use with twiist was favorable compared to what has been reported for other AID systems in real world settings. We look forward to reporting more real-world evidence on Eversense and the AID combination as our userbase expands.”
Brian Hansen, Chief Commercial Officer at Senseonics, added: “We’re delighted to be able to share this new data and our additional findings with the diabetes community at ADA. The fact that a single CGM sensor can deliver consistent performance across the first half and second half of a full year is outstanding. It validates the technology we have on the market today, in Eversense 365, and it validates our exciting product pipeline that is based on the same fundamental science. There is nothing more powerful than real-world evidence and this, alongside excellent anecdotal feedback, is galvanizing the Senseonics team as commercial momentum continues to grow.”
As the only implantable CGM available, Eversense 365 offers patients a truly differentiated CGM experience, providing one year of exceptionally accurate monitoring with minimal interruptions. Eversense 365’s unique approach allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.
Strong adherence and positive outcomes in open loop insulin regimens across all age groups
The larger dataset bolsters the previous findings presented at ATTD which underscored Eversense 365’s strong patient adherence, glucometrics and hypoglycemic outcomes. These findings, when combined with the previous analysis, reinforce that Eversense 365 can support the effective management of diabetes over a full one-year period with just one implantable CGM sensor.
Positive outcomes and engagement with Eversense 365 were seen across all age groups, with an average transmitter wear time of
Furthermore, more than
Strong initial performance from Eversense 365 and twiist AID system integration
Building on the earlier findings shared at ATTD, this analysis included an additional 153 sensors that had been used in combination with the twiist AID system for more than 30 days. This expanded and extended analysis highlights the strong performance of Eversense 365 as part of an AID system to date and suggests that the combination is already demonstrating a positive and meaningful clinical impact for people living with diabetes.
The data shows that people using the twiist AID system with Eversense 365 had a mean TIR of approximately
Eversense 365 and twiist integration users also had very strong adherence with a median sensor wear time of
About Eversense
Eversense 365 is developed by Senseonics and, as the only implantable CGM available, offers patients a truly differentiated CGM experience, providing One Year of exceptionally accurate monitoring with minimal interruptions. It benefits endocrinologists and care teams by offering their patients confidence in decision making, long-term peace of mind and enhanced quality of life with just one CGM. The unique approach also allows people to overcome common frustrations and interruptions experienced with traditional, short-term CGMs, so that patients can focus on managing their diabetes and not their CGM.
The Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to 365 days for Eversense® 365 and 180 days for Eversense® E3 in persons with diabetes age 18 and older. The systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time per week after day 14 for Eversense® 365 and one time per day after day 21 for Eversense® E3, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM Systems are prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://www.eversensediabetes.com/safety-info/.
About Senseonics
Senseonics Holdings, Inc. ("Senseonics") is a medical technology company focused on the development, manufacturing and commercialization of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM system Eversense® 365 and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
Senseonics Media Contact
Tim Stamper
FTI Consulting
Tim.Stamper@senseonics.com / Eversense365@FTIConsulting.com
Senseonics Investor Contact
Jeremy Feffer
LifeSci Advisors
investors@senseonics.com
1 GMI is an established metric that provides an estimated A1C using only CGM data, with a lower value indicating better management and reduced health risks. GMI is often used alongside TIR to provide a more complete picture of glycemic control.
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