Senseonics has initiated its first-in-human clinical feasibility study of Freedom, an investigational continuous glucose monitoring (CGM) system designed to operate for up to one year without an external transmitter. The technology builds on the company's Eversense 365 platform, introducing an integrated battery and Bluetooth connectivity that allow glucose readings to be transmitted directly from the implanted sensor to a mobile device.
Unlike traditional CGM systems that require an external wearable component attached to the skin, Freedom is designed to function entirely beneath the skin. Its miniaturized battery powers the glucose sensor and internal electronics, while Bluetooth Low Energy technology enables direct communication with compatible smartphones. This approach could eliminate the need for adhesive patches and external transmitters, potentially improving convenience and reducing skin irritation for people managing diabetes.
The early feasibility study will evaluate the system's safety and functional performance in humans, particularly its ability to maintain reliable wireless communication through skin and surrounding tissue. The trial follows preclinical studies conducted earlier in 2026, during which Senseonics tested different antenna configurations and implantation depths. According to the company, its selected design achieved a 100% communication success rate across more than 18,500 data points collected during approximately seven weeks of testing.
Freedom retains the optical glucose-sensing technology used in Eversense 365 while incorporating the additional electronics needed for fully implantable operation. The company aims to provide continuous glucose measurements without requiring patients to wear or replace external components, representing a potential advancement in long-term diabetes monitoring.
Senseonics plans to use findings from the feasibility study to inform a larger pivotal clinical trial expected to begin in 2027. Subject to successful clinical testing and regulatory approvals, the company is targeting commercial availability in 2028. The technology remains investigational, and its long-term safety and performance in humans have yet to be established.
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