Eversense’s implanted continuous glucose monitoring (CGM) system is safe and highly accurate over the 90-day sensor life in patients suffering from type 1 or type 2 diabetes, shows the latest results of the PRECISE II study.
According to the PRECISE II data published in Diabetes Technology & Therapeutics (DTT), a peer-reviewed journal from Mary Ann Liebert, Inc., publishers, over 93% of CGM glucose values were found to be within an acceptable range of reference values.
The prospective, multicenter PRECISE II study was carried out by Lynne Kelley, MD, Senseonics, Inc. (Germantown, MD), and a group of clinical researchers from across the U.S. The researchers have elucidated the study design and their discoveries in the article entitled “A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II.”
The study’s primary endpoint was the mean absolute relative difference (MARD) between reference measurements (from 40 to 400 mg/dL) and Eversense glucose values over the 90-day post-insertion period. The team demonstrated that the CGM sensor could be safely inserted and removed by clinicians having limited to no surgical experience after proper training. They reported only one serious adverse event related to sensor insertion/removal or device use.
Continuous glucose monitoring is becoming standard of care especially for insulin-requiring patients with diabetes. Eversense, if approved by the FDA, will become the first implantable CGM system for use lasting at least 3 months.
Satish Garg, MD - DTT Editor-in-Chief, Professor of Medicine and Pediatrics at the University of Colorado Denver (Aurora)