Senseonics begins first human study of Freedom Transmitter-Free CGM System

USA—Medical technology company Senseonics Holdings has begun the first human clinical study of its investigational Freedom continuous glucose monitoring (CGM) system to assess its safety and wireless glucose transmission capabilities ahead of a planned pivotal trial in 2027.

The device transmits glucose readings directly to a smartphone without a separate external transmitter worn on the body.

The early feasibility study will assess clinical safety and device functionality, with particular attention to the sensor’s integrated Bluetooth technology.

Senseonics plans to use the findings to guide the pivotal trial, with a potential commercial launch targeted for 2028.

Integrated sensing and wireless communication

Freedom builds on the sensing technology used in Senseonics’ Eversense 365 CGM system.

However, it includes an internal battery and embedded Bluetooth communication, eliminating the need for a separate on-body transmitter while aiming to maintain continuous glucose monitoring for up to one year with a single implanted sensor.

President and CEO Tim Goodnow said the first human study marks progress towards the company’s goal of eliminating external components from continuous glucose monitoring.

He said the design could offer a more discreet monitoring option for people with diabetes by removing the need to wear a separate transmitter.

Goodnow added that the company aims to advance sensing technology beyond incremental improvements and build on Eversense 365’s capabilities, which offer up to 365 days of continuous glucose monitoring.

The clinical study follows preclinical evaluations completed in the second quarter of 2026.

Those assessments examined different Bluetooth Low Energy antenna designs and sensor insertion sites to improve wireless transmission performance.

Building on the Eversense 365 platform

Senseonics currently markets Eversense 365, a prescription-only CGM system that uses an implanted sensor and a removable smart transmitter to relay glucose readings to mobile applications and compatible automated insulin delivery systems.

The system is designed for adults aged 18 and older with diabetes and is available in the United States and selected European markets.

It provides continuous glucose readings for up to 365 days, offering an alternative to frequent fingerstick testing.

Users may still need fingerstick measurements once a week after the first 14 days, when taking tetracycline medication, or when symptoms do not correspond with sensor readings.

In September 2024, Senseonics and Ascensia Diabetes Care announced that the US Food and Drug Administration had approved Eversense 365 for adults with type 1 and type 2 diabetes.

Freedom’s development could extend the company’s implantable monitoring platform by reducing the number of external components users need to wear.

For the CGM market, a successful transmitter-free design could offer another way to improve device convenience and long-term adherence, although its safety, performance, and commercial viability will depend on further clinical evaluation.

Sign up HERE to receive our email newsletters with the latest news and insights from Africa and around the world, and follow us on LinkedIn for updates.