Category: Diabetes/Prediabetes/Hypoglycemia

Monitor: 7

7 - HYPOGLYCEMIC PERFORMANCE EVALUATION OF A NEW IMPLANTABLE CGM SYSTEM

Thursday, Apr 25
12:30 PM – 1:00 PM

Objective :

A strong accuracy and safety profile of the new implantable Eversense CGM system in participants with type 1 or type 2 diabetes (T1D, T2D) was demonstrated in a prior multi-center, prospective, blinded study (PRECISE II).  The objective of the study was to conduct a subsequent prospective, multi-center study (PRECISION) was conducted to assess overall performance and safety with an unblinded device with specific focus in the hypoglycemic range.


Methods :

Effectiveness parameters of MARD between paired Eversense and Yellow Springs Instrument (YSI) reference glucose measurements and percent of CGM system agreement within 15 mg/dL or 15% (15/15% metric) of YSI reference measurements through 90 days for reference glucose values from 40 to 400 mg/dL were evaluated. The incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days post-insertion was the primary safety endpoint.


Results :

Thirty-five adults with T1D or T2D were inserted with the CGM system. CGM system agreement within 15/15% of reference values through 90 days was 85% over the glucose range of 40–400 mg/dL. 92% and 87% of CGM values were within 15 mg/dL of reference with corresponding mean absolute differences of 7.2 mg/dL and 7.6 mg/dL, respectively, in the hypoglycemic ranges of 40-60 and 61-80 mg/dL. The MARD against reference glucose values through 90 days was 9.6% (95% CI: 8.9, 10.4).  No early sensor failures and no device- or procedure- related SAEs were observed.


Discussion :

The accuracy and safety of the implantable Eversense CGM system over the 90-day sensor life was confirmed with an MARD of 9.6% over the glucose range of 40–400 mg/dL and 85% of CGM values within 15/15% of reference values. Accuracy was particularly strong in the hypoglycemic range with 92% of readings within 15/15% of reference values in the glucose range of 40 to 60 mg/dL. The favorable safety profile demonstrated in PRECISE II was corroborated in this study with no device- or procedure-related SAEs.


Conclusion :

The robust performance and favorable safety profile of the Eversense CGM system was verified in the PRECISION study which evaluated an unblinded system through 90 days. Of note, strong accuracy performance was attained in the hypoglycemic ranges.

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Mark Christiansen, MD

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.

Timothy Bailey

Clinical Assistant Professor, UCSD School of Medicine
2AMCR Institute Inc.
Escondido, California

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)

Leslie Klaff

Medical Director
Rainier Clinical Research Center
Renton, Washington

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.

Ron Brazg

Director and Principle Investigator
Rainier Clinical Research Center
Renton, Washington

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.

Katherine S Tweden

Vice President, Clinical Science
Senseonics, Incorporated
Germantown, Maryland

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.

Francine Kaufman