Senseonics Holdings, a diabetes company, announced the initiation of its first-in-human clinical study evaluating Freedom, an investigational next-generation CGM system designed to communicate directly with a mobile device without the need for an external on-body transmitter.
Freedom represents an important step in Senseonics' innovation pipeline and is being developed with a vision to make diabetes technology less visible and burdensome. It is an evolution of the same fundamental sensing technology as the Eversense 365 system, with the addition of an integrated battery and embedded Bluetooth communication capability. It is designed to have no requirement for an on-body component, while maintaining the benefits people already value with Eversense 365, providing exceptional accuracy over a full year with a single sensor, according to a press release.
"Now being tested in humans for the first time, the Freedom CGM represents our vison 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,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. "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."
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The initiation of this first-in-human clinical study is a key milestone for Senseonics as the Company continues to invest in its innovation pipeline. It is an early feasibility study to evaluate the device design concept with respect to clinical safety and device functionality, including the sensor’s direct Bluetooth communication capabilities. The study’s purpose is to demonstrate safety and generate insights to inform a planned pivotal study that Senseonics expects to initiate in 2027, with the company targeting a potential commercial launch in 2028.
The initiation of the first-in-human study follows encouraging results from preclinical studies completed during the second quarter of 2026, which evaluated multiple Bluetooth® Low Energy (BLE) antenna designs and implantation locations to optimize communication performance and guide configuration selection. Across approximately seven weeks of testing and more than 18,500 communication data points, the preferred design demonstrated 100% communication success within our target distance. As a result, the study identified a preferred antenna configuration and implantation approach for human evaluation.
“Freedom exemplifies our approach to innovation at Senseonics. We are focused on developing game-changing advances that simplify life with diabetes and help make diabetes technology less visible,” Mukul Jain, PhD, Chief Operating Officer of Senseonics, commented. “This R&D approach leverages validated technologies wherever possible to reduce risk and accelerate innovation. Supported by encouraging preclinical communication data, we are excited to begin evaluating Freedom in humans. This program is being driven by what we consistently hear from people living with diabetes and it is what Senseonics was founded to deliver – a one-year CGM sensor with nothing required on-body.”
About Senseonics
Senseonics Holdings, Inc. ("Senseonics") is a diabetes company redefining continuous glucose monitoring (CGM) with long-term implantable sensing technology. Driven by a mission to transform lives in the diabetes community, Senseonics is the maker of Eversense 365, the world's first and only one-year CGM system, and is advancing a differentiated pipeline of innovation.
About Eversense 365
Eversense 365 is the only long-term continuous glucose monitoring (CGM) system available, offering people with diabetes a truly differentiated CGM experience. Designed for people with diabetes who demand more, Eversense 365 combines a small sensor inserted under the skin by a healthcare provider with a removable smart transmitter that delivers real-time glucose data to a mobile app or an integrated Automated Insulin Delivery (AID) system.
