Implanted continuous glucose sensor proven safe and accurate in types 1 and 2 diabetes
New Rochelle, NY, February 12, 2018–Results of the PRECISE II study showed the implanted continuous glucose monitoring (CGM) system from Eversense to be safe and highly accurate over the 90-day sensor life in patients with type 1 or type 2 diabetes. More than 93% of CGM glucose values were within an acceptable range of reference values, according to the PRECISE II data reported in Diabetes Technology & Therapeutics (DTT), a peer-reviewed journal from Mary Ann Liebert, Inc., publishers.
Lynne Kelley, MD, Senseonics, Inc. (Germantown, MD), and a team of clinical researchers from across the United States conducted the prospective, multicenter PRECISE II study. They describe the study design and their findings in the article entitled "A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II."
The primary endpoint of the study was the mean absolute relative difference (MARD) between Eversense glucose values and reference measurements (from 40-400 mg/dL) over the 90-day post-insertion period. The researchers showed that clinicians with limited to no surgical experience could safely insert and remove the CGM sensor after appropriate training. Only one serious adverse event was reported related to device use or sensor insertion/removal.
"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," says DTT Editor-in-Chief Satish Garg, MD, Professor of Medicine and Pediatrics at the University of Colorado Denver (Aurora).
About the Journal
Diabetes Technology & Therapeutics (DTT) is a monthly peer-reviewed journal that covers new technology and products for the treatment, monitoring, diagnosis, and prevention of diabetes and its complications. Led by Editor-in-Chief Satish Garg, MD, the Journal covers topics that include noninvasive glucose monitoring, implantable continuous glucose sensors, novel routes of insulin administration, genetic engineering, the artificial pancreas, measures of long-term control, computer applications for case management, telemedicine, the Internet, and new medications. Tables of contents and a free sample issue may be viewed on the Diabetes Technology & Therapeutics (DTT) website. DTT is the official journal of the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD).
The International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) presents top caliber scientific programs that have provided participants with cutting-edge research and analysis into the latest developments in diabetes-related technology. A unique and innovative conference, ATTD brings the world's leading researchers and clinicians together for a lively exchange of ideas and information related to the technology, treatment, and prevention of diabetes and related illnesses.
About the Publisher
Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Thyroid, Metabolic Syndrome and Related Disorders, Journal of Aerosol Medicine and Pulmonary Drug Delivery, Childhood Obesity, and Population Health Management. Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News ), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 80 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.