Senseonics initiates first-in-human study of CGM with no-body component

GERMANTOWN, Md. – Senseonics has initiated its first-in-human clinical study evaluating Freedom, an investigational next-generation continuous glucose monitor (CGM) system designed to communicate directly with a mobile device without the need for an external on-body transmitter. The company says the Freedom 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. "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,” said Tim Goodnow, PhD, president and CEO of Senseonics. “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." Senseonics says the study’s purpose is to demonstrate safety and generate insights to inform a planned pivotal study that the company expects to initiate in 2027, with a targeted potential commercial launch in 2028. The company says it follows encouraging results from preclinical studies completed during the second quarter of 2026 evaluating 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, it says the preferred design demonstrated 100% communication success within target distance. As a result, it says, the study identified a preferred antenna configuration and implantation approach for human evaluation.

• Related reading: Senseonics launches Eversense 365 in Sweden, with other countries to follow.