Objective : The safety and accuracy of the new implantable Eversense CGM system through 90 days in participants with type 1 or type 2 diabetes (T1D, T2D) was evaluated using a prospective, multi-center, blinded study design (PRECISE II). The study demonstrated that the CGM was safe with a mean absolute relative difference (MARD) of 8.8%. The objective of this evaluation was to assess the effect of a new glucose calculation algorithm on the performance of the Eversense CGM.
Methods : The algorithm to calculate glucose (SW602) was updated after the study was conducted. The raw data collected by the Sensor was converted into glucose readings using SW602. Accuracy improvement in early Sensor life and in the hypoglycemic range throughout the Sensor life was the goal for SW602 algorithm. The efficacy measures of MARD between paired Eversense and YSI reference measurements and percent of system agreement within 15 mg/dL or 15% of Yellow Springs Instrument (YSI) reference glucose measurements (15/15% metric) through 90 days were evaluated.
Results : The CGM system was inserted in 90 participants in PRECISE II. SW602 resulted in 87% of CGM values within 15/15% of reference values over the total glucose range of 40–400 mg/dL (15,753 matched pairs). Of note, accuracy <54 mg/dL showed 89% of CGM values within 15mg/dL. The overall MARD improved to 8.5% (95% CI: 8.0, 9.1).
Application of the updated glucose calculation algorithm to the raw sensor data from PRECISE II study using a post-hoc analysis method improved the MARD from 8.8% to 8.5% with a strong 15/15% metric of 87%. Severe hypoglycemic accuracy of < 54 mg/dL was also robust with 89% of readings within 15 mg/dL.
Conclusion : An improved MARD of 8.5% was demonstrated for the Eversense CGM system using an updated glucose calculation algorithm through 90 days of Sensor wear time.
Mark Christiansen, MD– Co-Medical Director, Endocrinologist, Diablo Clinical Research Inc.,, Walnut Creek, California
Timothy Bailey– Clinical Assistant Professor, UCSD School of Medicine, 2AMCR Institute Inc., Escondido, California
Leslie Klaff– Medical Director, Rainier Clinical Research Center, Renton, Washington
Ron Brazg– Director and Principle Investigator, Rainier Clinical Research Center, Renton, Washington
Anna Chang– Medical Director of Endocrinology, John Muir Health Clinical Research Center, Concorde, California
Carol Levy– Director, Mount Sinai Diabetes Center, New York, New York
David Lam– ASSISTANT PROFESSOR | Medicine, Endocrinology, Diabetes and Bone Disease, Mount Sinai Diabetes Center, New York, New York
Douglas Denham– Medical Director, Clinical Trials of Texas, Inc., San Antonio, TX, USA
Bruce Bode– Clinical Associate Professor in the Department of Medicine, Emory University
Katherine S Tweden– Vice President, Clinical Science, Senseonics, Incorporated, Germantown, Maryland
Co-Medical Director, Endocrinologist
Diablo Clinical Research Inc.,
Walnut Creek, California
Dr. Christiansen has been a sub-investigator and principal investigator with Diablo Clinical Research since 2007. He is an expert and specializes in glucose clamp studies. He also maintains his private practice in Pleasanton. Dr. Christiansen has prior clinical research experience in over eight studies including (but not limited to) diabetes type 1 and 2, neuropathy, dyslipidemia, hypertension, metabolic syndrome, fibromyalgia, osteoporosis, osteoarthritis and obesity. Earlier in his medical career, Dr. Christiansen was an Assistant Clinical Physician at San Francisco General Hospital and a staff endocrinologist at Contra Costa Endocrine Associates in Walnut Creek. Dr. Christiansen’s certifications include the National Board of Medical Examiners, the American Board of Internal Medicine, the American Board of Diabetes, Endocrinology and Metabolism and he is a certified Clinical Densitometrist.
Clinical Assistant Professor, UCSD School of Medicine
2AMCR Institute Inc.
Board certified in endocrinology, metabolism and internal medicine, Dr. Bailey has specialized in treating AMCR patients with diabetes, osteoporosis, thyroid diseases and lipid disorders since 1990. A clinical associate professor at the University of California San Diego School of Medicine, he is very active in conducting clinical trials, educating patients and physicians, and consulting with technology firms to improve patient care.
Education 1984 Mount Sinai School of Medicine
Post Doctoral Training 1984-1987 Internal Medicine Residency (St. Luke's Hospital, New York)
Research Fellowships 1987-1990 Endocrinology & Metabolism (SUNY Downstate Health Science Center)
Rainier Clinical Research Center
Leslie J. Klaff was born in the coastal city of Durban, South Africa and received his medical education at the University of Witwatersrand, Johannesburg, South Africa. After 2 years of medical residency in Johannesburg he spent a year in London, UK furthering his education and then returned to Cape Town, South Africa where he completed his residency. He then joined the Endocrine Unit at the University of Cape Town, where he developed his life-long interest in diabetes and its complications. He completed a PhD and a clinical fellowship in Endocrinology and joined the full-time faculty at the University of Cape Town in 1981. In 1983 he was recruited to the University of Washington, Seattle, as a sub-investigator in the multi-centered international Diabetes Control and Complications Trial. He rose to be an Associate Professor of Medicine at the University of Washington, but in 1989 left to enter Endocrine practice in Renton, WA. In 2006 Dr Klaff retired from practice to concentrate on his research.
Dr Klaff is currently a Clinical Professor of Medicine at the University of Washington. He is board certified in Internal medicine and Endocrinology and is a Fellow of the Royal College of Physicians (Edinburgh, UK) and a Fellow of the American College of Endocrinologists. He is an author on over 50 scientific articles and book chapters.
Director and Principle Investigator
Rainier Clinical Research Center
Dr. Brazg was born in South Africa and received his medical education at the University of the Witwatersrand in Johannesburg, South Africa. He completed his Internal Medicine training at the University Hospital and in 1986, relocated to Detroit, MI where he completed research training in Diabetes at Wayne State University and was Chief Resident in Internal Medicine at Sinai Hospital. He moved to the Pacific Northwest in 1990 to complete a Fellowship in Endocrinology and Metabolism at the University of Washington in Seattle.
In 1992 after completing his Endocrinology training he entered private practice in Renton, WA where he maintained an active clinical diabetes and endocrine practice at Southlake Clinic Diabetes and Thyroid Center.
In 2012 he retired from practice to concentrate his efforts full time as medical director of Rainier Clinical Research Center. He has also served as the medical director of the Valley Medical Center Diabetes Education program and HMR weight loss program. Dr Brazg was one of the founding members of Rainier Clinical Research Center and has been actively involved as a director and principal investigator with the center for over twenty years.
Dr. Brazg is board certified in both Internal Medicine and Endocrinology, and is a Fellow of the American College of Endocrinology. He has given numerous lectures and published multiple journal articles in the field of diabetes, hyperlipidemia and associated metabolic disorders. He is an Assistant Clinical Professor of Medicine at the University of Washington and has been active in teaching both medical students and residents.
Medical Director of Endocrinology
John Muir Health Clinical Research Center
American Board of Internal Medicine
American Board of IM/Endocrinology, Diab, Metab
Medical School: University of California at San Diego
Internship/Residency: University of California at San Diego
Fellowship: University of California at San Diego
Diabetes- New Therapies and Technologies
Calcium Disorders and Osteoporosis
Mount Sinai Diabetes Center
New York, New York
Dr. Levy is Director of the Mount Sinai Diabetes Center and an Associate Professor of Medicine, Endocrinology, Diabetes and Bone Disease and Obstetrics, Gynecology and Reproductive Science at the Icahn School of Medicine and Mount Sinai Hospital in New York.
She is a board-certified Endocrinologist and Certified Diabetes Educator. She specializes in providing care for patients with in Type 1 and Type 2 diabetes as well as general endocrine conditions.
Her academic interests are in the development of new treatments for diabetes including Type 1 and Type 2 diabetes and gestational diabetes. She is the director of diabetes clinical research in the Division of Endocrinology at Mount Sinai and is the principal investigator in many trials evaluating treatments for type 1 and type 2 diabetes. She collaborates with investigators in divisions across Mount Sinai and affiliated institutions.
Dr. Levy received her medical degree from Northwestern University Medical School. She completed her residency in internal medicine and her fellowship in endocrinology at Beth Israel Deaconess Medical Center- Harvard Medical School.
ASSISTANT PROFESSOR | Medicine, Endocrinology, Diabetes and Bone Disease
Mount Sinai Diabetes Center
New York, New York
David W. Lam, MD is a practicing Endocrinologist in New York, NY. Dr. Lam graduated from University of Maryland School of Medicine in 2007 and has been in practice for 11 years. He currently practices at Mount Sinai Medical Center and is affiliated with The Mount Sinai Hospital. Dr. Lam also practices at Demetrius Pertsemlidis MD in New York, NY. In addition to English, Dr. Lam's practice supports these languages: Spanish, Korean, German, Tagalog, Vietnamese, Italian, Polish, Russian and French.
Clinical Trials of Texas, Inc., San Antonio, TX, USA
Dr Denham is a Family Medicine physician with 12 years of research experience in the Metabolic Disease/Women’s Health/Dermatology and Psychiatry fields in San Antonio, Texas. He has been Medical Director of Clinical Trials of Texas for the last 8 years. He has experience in Phase I-IV studies as well as Medical Device experience.
Clinical Associate Professor in the Department of Medicine
Dr. Bruce Bode is a diabetes specialist with Atlanta Diabetes Associates in Atlanta, Georgia, and is currently on the faculty of Emory University as a clinical associate professor in the Department of Medicine. He received his medical degree from Emory University School of Medicine and completed an internship and residency in internal medicine at Emory University Affiliated Hospitals and a fellowship in diabetes with Paul C. Davidson, MD.
He is considered one of the leading experts in the world on insulin delivery and glucose sensing
Vice President, Clinical Science
Katherine S. Tweden, Ph.D. is the Vice President, Clinical Sciences. She is an experienced executive with over 25 years in research, clinical and regulatory who most recently guided a novel class three active implantable obesity medical device from invention through FDA approval at EnteroMedics Inc as one of the co-inventors and founders. Since 1990, she worked in the medical device industry in Research and Development roles in the fields of coronary vascular disease, heart valve disease and periodontal ligament regeneration at HeartStent Corporation, St Jude Medical, Inc and W.L. Gore and Associates, respectively. Dr. Tweden has over 60 patents and publications in related fields. Dr. Tweden received a Bachelor of Arts in chemistry from Gustavus Adolphus College, a M.S. and Ph.D. in biomedical engineering from Iowa State University and post-doctorates in oral biology and surface chemistry from State University of New York at Buffalo.