First Ever Real-World Evidence of Eversense 365 Presented at ATTD Demonstrates Sustained Performance and Positive Impact Throughout One-Year of Wear

Rhea-AI Summary

Senseonics (NASDAQ:SENS) presented real-world data at ATTD (March 11-14, 2026) showing sustained performance of Eversense 365 across one year in 5,059 US sensors. Key metrics: mean GMI 7.14%, mean Time in Range 66%, transmitter wear 93.8%, and >75% meeting hypoglycemia targets.

Age subgroup gains included >65s with GMI 6.99%, TIR >70% and >95% wear; early AID combo data (n≈120) showed GMI 6.79% and TIR 77%.

Positive

• Large real-world cohort of 5,059 implanted sensors
• High adherence with 93.8% mean transmitter wear time
• Strong glycemic control: mean GMI 7.14% and TIR 66%
• Older adult benefit: >65 group GMI 6.99% and TIR >70%
• Encouraging AID combo: early twiist data GMI 6.79% and TIR 77%

Negative

• No randomized comparator data reported in this real-world analysis
• Early AID combination sample small (≈120 users) and short duration (>7 days)
• Results limited to US commercial users on open-loop regimens, limiting generalizability

Key Figures

Sensors analyzed: 5,059 sensors Average wear time: 93.8% Mean GMI: 7.14% +5 more

8 metrics

Sensors analyzed 5,059 sensors First real-world Eversense 365 CGM study in US

Average wear time 93.8% Overall transmitter wear time over one year

Mean GMI 7.14% All Eversense 365 users over one year

Time in Range 66% All Eversense 365 users over one year

Hypoglycemia target achievement Over 75% of users Users meeting hypoglycemic targets with Eversense 365

Older adults GMI 6.99% Users >65 years on Eversense 365

AID combo GMI 6.79% First ~120 twiist AID + Eversense 365 users

AID combo TIR 77% First ~120 twiist AID + Eversense 365 users

Market Reality Check

Price: $5.64 Vol: Volume 455,515 vs 20-day ...

normal vol

$5.64 Last Close

Volume Volume 455,515 vs 20-day average 526,996 (relative volume 0.86) suggests no outsized trading response. normal

Technical Shares at $5.64 trade -64.17% below the 52-week high of $15.74 and below the $8.26 200-day MA, indicating a pre-existing downtrend despite today’s modest 0.71% gain.

Peers on Argus

SENS gained 0.71% while peers showed mixed moves (e.g., BFLY +2.98%, RXST -4.06%...

1 Up 1 Down

SENS gained 0.71% while peers showed mixed moves (e.g., BFLY +2.98%, RXST -4.06%, TCMD -2.6%, PACB +2.31%). Momentum scanner also flagged CBLL up and PACB down, reinforcing stock-specific rather than sector-wide drivers.

Historical Context

5 past events · Latest: Mar 02 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 02	Earnings and outlook	Positive	-18.1%	Strong Q4 and 2025 growth with higher 2026 guidance and margin targets.
Feb 19	Product integration news	Positive	+3.7%	Launch of twiist AID system fully integrated with year-long Eversense 365 CGM.
Jan 29	EU approval news	Positive	+5.3%	CE Mark approval enabling Eversense 365 commercialization in key EU markets.
Jan 28	Conference participation	Positive	+2.0%	Announcement of participation in BTIG MedTech and digital health conference.
Jan 12	Preliminary earnings	Positive	-1.5%	Preliminary record Q4 and 2025 revenue with strong growth and guidance.

Pattern Detected

News has generally been positive, but reactions are mixed, with some strong selloffs on earnings despite growth and more favorable moves on product and partnership updates.

Recent Company History

Over the last few months, Senseonics has focused on expanding Eversense 365. On Jan 12 and Mar 02, it reported strong preliminary and full-year 2025 revenue growth and higher guidance, yet shares fell after earnings. By contrast, CE Mark approval for Eversense 365 on Jan 29 and the U.S. twiist AID launch on Feb 19 saw positive price reactions. Today’s real-world data further supports the year-long CGM and its integration trajectory.

Regulatory & Risk Context

Active S-3 Shelf · $300 million

Shelf Active

Active S-3 Shelf Registration 2025-08-06

$300 million registered capacity

A Form S-3 universal shelf filed on Aug 06, 2025 allows Senseonics to issue up to $300 million in various securities, including a $100 million ATM program with TD Cowen. The shelf, currently noted as not effective with no recorded usage, provides capacity for future capital raises through its Aug 06, 2028 expiration.

Market Pulse Summary

This announcement highlights strong real-world performance of Eversense 365 over a full year, with h...

Analysis

This announcement highlights strong real-world performance of Eversense 365 over a full year, with high adherence and encouraging glucometrics across age groups and in early twiist AID use. Recent history shows expanding approvals and integrations alongside mixed market reactions, particularly around earnings. Investors may watch future real-world AID data, progress in European launches, and any use of the existing $300 million shelf for additional context.

Key Terms

continuous glucose monitoring (cgm), glucose management indicator (gmi), time in range (tir), hypoglycemia, +4 more

8 terms

continuous glucose monitoring (cgm) medical

"implantable Continuous Glucose Monitoring (CGM) Systems for people with diabetes"

A continuous glucose monitoring (CGM) system is a small wearable sensor and transmitter that measures a person’s blood sugar levels continuously and sends real‑time readings to a display or smartphone app, reducing the need for finger‑prick tests. Investors care because CGM shifts diabetes care toward ongoing device sales, subscriptions and data services; wider patient adoption, insurance coverage and better accuracy can drive steady revenue and create opportunities for new health products and analytics, similar to moving from one‑off purchases to a subscription service.

glucose management indicator (gmi) medical

"This resulted in a mean Glucose Management Indicator (GMI) of 7.14%"

A glucose management indicator (GMI) is a calculated estimate of a person’s average blood sugar level derived from data collected by wearable glucose sensors over days or weeks. It acts like a rolling report card—translating continuous readings into a single number that approximates a lab test used in diabetes care—so investors watch it as a practical measure of how well a device or therapy controls sugar, affecting product adoption, regulatory assessment, and reimbursement prospects.

time in range (tir) medical

"a mean Time in Range (TIR) of 66%, demonstrating effective glycemic control"

The percentage of time a person’s blood sugar stays within a pre-set target range, usually measured by a continuous glucose monitor; think of it as a fuel gauge showing how often levels stay in the “green” zone. Investors care because higher time in range is a simple, widely accepted measure of a device or therapy’s effectiveness, and it can influence regulatory decisions, insurance coverage, patient adoption and long-term demand for related products.

hypoglycemia medical

"over 75% of users of the implanted, year-long CGM system achieved hypoglycemic targets"

Hypoglycemia is a condition where blood sugar falls too low to fuel the body and brain, causing symptoms like shakiness, confusion, sweating or fainting. Think of it as a car running low on gas: systems slow or fail until fuel is restored. Investors care because treatments, devices or drugs that cause or prevent hypoglycemia affect patient safety, regulatory approval, product labeling and market acceptance, which influence a company’s commercial prospects.

automated insulin delivery (aid) medical

"commercial launch of the twiist™ Automated Insulin Delivery (AID) system with Eversense 365"

Automated insulin delivery (AID) is a medical system that combines a continuous glucose monitor, an insulin pump, and software to automatically adjust insulin doses in real time, similar to cruise control for blood sugar. It matters to investors because AID represents a growing, recurring-revenue segment of diabetes care influenced by device approvals, reimbursement rules and software updates, which can drive sales, service subscriptions and competitive differentiation in the healthcare market.

ce mark regulatory

"following the recent CE mark approval and upcoming launch of Eversense 365"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

food and drug administration regulatory

"approved by the United States Food and Drug Administration in September of 2024"

A government agency that reviews and regulates medicines, medical devices, food safety, and related products to ensure they are safe and effective for public use. Investors watch its actions like a referee’s calls: approvals, warnings, inspections or recalls can directly affect a product’s ability to reach the market, a company’s sales and costs, and overall business risk and valuation.

prescription devices regulatory

"The Eversense CGM Systems are prescription devices; patients should talk"

Prescription devices are medical tools or machines that can only be sold or used when a licensed healthcare professional authorizes them, similar to how certain chemicals or power tools require a trained operator. They matter to investors because sales depend on medical approvals, doctors’ willingness to prescribe, and insurance coverage, so regulatory setbacks, pricing limits or slow adoption can directly affect revenue and growth prospects.

AI-generated analysis. Not financial advice.

New data shows positive real-world impact of the world’s first and only one-year CGM, with a full year of strong patient adherence, glucometrics and hypoglycemic outcomes

Eversense 365 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

GERMANTOWN, Md., March 14, 2026 (GLOBE NEWSWIRE) -- Senseonics, 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 new data from a real-world evidence study which demonstrates the sustained performance and positive impact of Eversense 365 across the full one-year period. These findings were presented during an oral presentation entitled ‘Real-World Evaluation Of The Implantable One Year Eversense 365 CGM System’ at the 19th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD), taking place on March 11-14 in Barcelona, Spain.

“The promise of a year-long CGM has now been demonstrated in the real world,” said Francine Kaufman, M.D., Chief Medical Officer at Senseonics. “Since Eversense 365 was launched in the US, we have consistently heard positive feedback about the system and its impact from both patients and their healthcare providers. Today, we have presented real-world evidence that further validates our belief in this technology and what we are hearing from the diabetes community. The data demonstrate that Eversense 365 can perform exceptionally well and consistently across its entire lifespan, with strong adherence supporting a full year of positive glycemic outcomes with just one sensor.”

Strong adherence and positive outcomes
The study evaluated the first 5,059 real-world Eversense 365 CGM sensors to be used by patients in the US, all with open-loop insulin regimens. The analysis revealed strong patient adherence, glucometrics and hypoglycemic outcomes, demonstrating how Eversense 365 can support effective management of diabetes over a full one-year period with just one implantable CGM sensor.

Patients using Eversense 365 had an average transmitter wear time of 93.8%, with comparable results for the first and second six-month periods, indicating a year of consistent and meaningful system use. This resulted in a mean Glucose Management Indicator (GMI) of 7.14% and a mean Time in Range (TIR) of 66%, demonstrating effective glycemic control. 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.

Furthermore, over 75% of users of the implanted, year-long CGM system achieved hypoglycemic targets, reinforcing that Eversense 365 is the most accurate CGM in low glucose ranges^1,2,3, where errors can have the greatest impact on patient safety and treatment decisions. The real-world analysis also showed that glucometrics and hypoglycemic outcomes were comparable for both the first six months and second six months of wear

Specific age group benefits
Additionally, analysis by age revealed that Eversense 365 supported positive glucometrics and outcomes across all age groups. However, glycemic outcomes were seen to improve with increasing age, with the >65 year-old population achieving a mean GMI of 6.99% and a mean TIR of over 70%, with over 85% achieving hypoglycemic targets. The trend was also observed with adherence, with over 95% average wear time in those 65 years and older. This suggests that, whilst all age groups can benefit from Eversense 365, there may be particular benefits and positive outcomes in older populations.

Furthermore, the analysis suggested that Eversense 365 could bring specific benefits to young adults (aged 18-25), who typically have poorer glycemic control. Encouragingly, this age group had a mean GMI of 7.3% with a mean wear time over 90%, which again demonstrates strong adherence.

Encouraging early analysis of AID combination
Two weeks after the commercial launch of the twiist™ Automated Insulin Delivery (AID) system with Eversense 365, real-world data was also analyzed from the first ~120 people who had used the combined system for more than seven days. The glucose outcomes were extremely encouraging with a mean GMI of 6.79%, mean TIR of 77% and time in hypoglycemia of 2.7%, all meeting the international consensus targets. twiist is the first AID system to be compatible with Eversense 365 and, whilst still in the early stages, the initial data analysis suggests that this powerful combination is already having a positive clinical impact. Senseonics plans to present a longer-term real-world analysis later this year.

Brian Hansen, Chief Commercial Officer at Senseonics, added: “We are proud to present these data at ATTD, which is always a fantastic opportunity to connect with the diabetes ecosystem and discuss the latest developments in technology and care. The meeting is particularly timely for us this year following the recent CE mark approval and upcoming launch of Eversense 365 in select European markets. We are gaining momentum commercially in the US and look forward to bringing the benefits of this unique, implantable CGM to new patients and geographies.”

Eversense 365 is the world’s first and only one year CGM, which was approved by the United States Food and Drug Administration in September of 2024 and launched across the country in October of the same year. In January 2026, Eversense 365 received European CE Mark approval and Senseonics expects to launch Eversense 365 in Germany, Italy, Spain and Sweden in the coming months.

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.

_{¹ Senseonics. (2026) Eversense 365 Continuous Glucose Monitoring System User Guide. LBL-7702-01-001
² Abbott. (2024) Freestyle Libre 3 PLUS User Guide ART49385-001
³ Dexcom (2025) G7 15 Day User Guide AW00078-10 MT-00078-10}

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

FAQ

What real-world outcomes did Senseonics report for Eversense 365 at ATTD March 2026 (SENS)?

The study reported mean GMI 7.14%, mean Time in Range 66%, and 93.8% transmitter wear time. According to Senseonics, these results come from 5,059 US sensors and show comparable performance across the first and second six-month periods of wear.

How did Eversense 365 perform in older adults in the ATTD 2026 real-world analysis (SENS)?

Older adults (>65) achieved mean GMI 6.99%, TIR over 70% and >95% wear time. According to Senseonics, this subgroup also had more than 85% meeting hypoglycemia targets, indicating particularly strong outcomes in that age group.

What early results were reported for the twiist AID plus Eversense 365 combination (SENS)?

Early analysis of ~120 users showed mean GMI 6.79%, mean TIR 77% and time in hypoglycemia 2.7%. According to Senseonics, these initial real-world outcomes met international consensus targets after more than seven days of combined use.

Does the ATTD real-world study show stable sensor accuracy for full one-year wear of Eversense 365 (SENS)?

Yes — glucometrics and hypoglycemic outcomes were comparable between the first and second six months of wear. According to Senseonics, that comparability indicates sustained accuracy and performance from a single sensor across one year.

How large and representative was the dataset for the Eversense 365 real-world analysis presented at ATTD (SENS)?

The analysis included the first 5,059 US Eversense 365 sensors used in open-loop regimens. According to Senseonics, the cohort reflects early commercial adopters but is limited to US users and open-loop therapy settings.

What are the main limitations investors should note about the Eversense 365 ATTD real-world data (SENS)?

Key limitations: no randomized control arm, subgroup AID data short and small (~120 users), and results derive from US commercial users on open-loop regimens. According to Senseonics, longer-term and broader analyses are planned.