Senseonics completes U.S. patient enrollment in PROMISE 180-day clinical study
Senseonics Holdings announced the completion of patient enrollment in the Eversense PROMISE 180-day sensor Clinical Study. The PROMISE Clinical Study is intended to evaluate the safety and efficacy of the Eversense CGM System in people with diabetes over a 180-day period for the pre-market application submission to the U.S. Food and Drug Administration. This system has previously received its CE Mark and is currently commercially available across Europe. The 181 study participants at 8 sites across the United States had the Eversense CGM System inserted subcutaneously as part of the study. "I am thrilled to be able to offer a long-term implantable sensor to my patients through the Eversense 180-day clinical study," said Satish Garg, MD, Professor of Medicine and Pediatrics at the Barbara Davis Center, University of Colorado Health. "This long-term CGM could be a game changer for people with diabetes. At the Barbara Davis Center, 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."