Medical technology company Senseonics Holdings has begun a first-in-human clinical study to assess Freedom, its investigational continuous glucose monitoring (CGM) system.
The device is designed to transmit data directly to a mobile handset without requiring an external on-body transmitter.
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The early feasibility trial focuses on clinical safety alongside device functionality, specifically evaluating the sensor’s direct Bluetooth capabilities.
Senseonics intends to use the resulting safety data and findings to guide a pivotal trial planned for 2027. The company is aiming for a potential commercial release in 2028.
Freedom builds on the fundamental sensing mechanism used in the Eversense 365 system, incorporating an integrated battery and embedded Bluetooth communication.
The design aims to eliminate external components while maintaining continuous one-year glucose sensing from a single implanted sensor.
Senseonics president and CEO Tim Goodnow said: “Now being tested in humans for the first time, the Freedom CGM represents our vision to eliminate the requirement for an on-body component, effectively making continuous glucose monitoring invisible.
“We believe this represents an extremely attractive proposition for millions of people with diabetes, and we are proudly leading the race to get there.
“At Senseonics, we are not interested in incremental innovation. Our mission is to transform lives in the diabetes community and push the boundaries of sensing technology to improve health and wellbeing. Eversense 365 redefined what a CGM could be by becoming the world’s first and only one-year system, and we are just getting started.”
The human clinical trial follows preclinical assessments completed in the second quarter of 2026. Those animal evaluations examined several Bluetooth Low Energy antenna layouts and insertion sites to refine transmission performance.
Senseonics currently markets Eversense 365, a long-term CGM system with a sensor inserted by a healthcare provider and a removable smart transmitter that relays glucose readings to mobile applications or integrated automated insulin delivery systems.
The prescription-only device is approved in Europe and cleared in the US for individuals aged 18 and above, offering continuous readings for up to 365 days to replace fingerstick measurements.
Fingerstick tests are generally required once a week after day 14, when taking tetracycline medication, or when symptoms do not match sensor readings. Eversense 365 is available in selected European markets and the US.
In September 2024, Senseonics and Ascensia Diabetes Care announced that the US Food and Drug Administration had approved the Eversense 365 CGM system for people aged 18 and over with type 1 and type 2 diabetes.
