The PROMISE Clinical Study has been designed to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes for 180 days
Image: Senseonics designs and develops advanced glucose monitoring products. Photo: Courtesy of Chokniti Khongchum from Pixabay.
Senseonics Holdings, a US-based medical technology company, has completed the enrolment of patients in the Eversense PROMISE 180-day sensor Clinical Study.
The company has developed and commercialised Eversense continuous glucose monitoring (CGM) system, which is set to be the first and only long-term, implantable CGM system for diabetes patients.
Senseonics said that its Eversense CGM System has been designed for continually measuring glucose levels in patients aged 18 and older with diabetes for up to 90 days.
Senseonics clinical sciences vice-president Katherine Tweden said: “We are pleased to have completed enrollment in this important study which demonstrates our continued progress in transforming CGM technology.
“This is the first study in the US in which study participants are implanted with a single sensor which will produce accurate continuous glucose measurements for up to half of a year. We expect to have the full data for analysis at the end of the first quarter of 2020 for submission to the FDA later that year.”
The Eversense PROMISE 180-day sensor Clinical Study
The PROMISE Clinical Study has been designed to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes for 180 days. The clinical study is aimed at obtaining pre-market approval from the US Food and Drug Administration.
The study enrolled 181 participants at eight sites across the US, and the study involves subcutaneous insertion of the Eversense CGM System. The sensor insertion and removal procedures are performed by a health care provider.
Eversense CGM System has been previously approved in Europe with CE Mark and is available across Europe as a prescription device.
Senseonics designs, develops and commercialises advanced glucose monitoring products to help people with diabetes.
Furthermore, the company’s CGM Systems, Eversense and Eversense XL, feature a small sensor that is inserted under the skin. The sensor communicates with a smart transmitter to automatically send glucose data to a smartphone app every five minutes.
University of Colorado Health medicine and paediatrics professor Satish Garg said: “I am thrilled to be able to offer a long-term implantable sensor to my patients through the Eversense 180-day clinical study. This long-term CGM could be a game changer for people with diabetes.
“At the Barbara Davis Centre, we actively participate in clinical trials that bring the latest diabetes technology and treatments to patients which change the way they manage their diabetes – now and in the future. The PROMISE study promises to do so.”