Objective : The novel long-term implantable Eversense continuous glucose monitoring system (CGM) has been demonstrated to be safe and accurate against a standard reference glucose analyzer. The effectiveness and safety of Eversense was studied in a Home use (HOUSE) setting in Sweden using SMBG readings as reference.
Methods : HOUSE was a prospective, multi-center study conducted in two, serial 90 day sensor insertion stages in 18 participants with T1D. In the first stage, one sensor was inserted in the upper arm and one was inserted in the abdomen. At the end of the first stage, both sensors were removed and participants chose either arm or abdomen for the next sensor insertion stage. Fingerstick measurements were used as reference to assess accuracy of the CGM system. Safety and SMBG data were collected every 30d.
Results : Fifteen males and 3 females with mean age 40±14 years and T1D duration 23± 14 years were included. 15826 matched CGM/SMBG pairs were generated with 9952 from the upper arm and 5874 from the abdomen. The overall MARD of the system was 14.9%± 16.4% using SMBG as reference. The abdomen MARD was 16.3%±18.0% and upper arm was 14.0%± 15.2%. No device-related serious adverse events (SAEs) were reported.
Discussion : The Eversense CGM demonstrated robust accuracy when placed in either the abdomen or the arm in participants with T1D in a home use setting and was consistent with that reported for other CGM systems in the same conditions. The arm MARD was shown to be higher than the abdomen MARD based on the mean values. The safety profile was excellent with no related SAEs.
In a home use setting, the Eversense CGM system was demonstrated to be safe and have reliable accuracy using SMBG as reference. Accuracy in the upper arm demonstrated better point accuracy than in the abdomen.
Magnus Löndahl– Associate Professor, Lund University, Lund, Sweden
Mona Landin-Olsson– Department of Clinical Sciences, Lund Assistant head of department, Lund University, Lund, Switzerland
Stig Attval– Associate Professor, Sahlgrenska University Hospital, Sahlgrenska, Sweden
Colleen Mdingi– Group Leader, Clinical Database Management., Senseonics, Incorporated, Germantown, Maryland
Katherine S Tweden– Vice President, Clinical Science, Senseonics, Incorporated, Germantown, Maryland
Francine Kaufman– Vice President, Clinical Science, Senseonics, Incorporated, Germantown, Maryland
Skills and Expertise: Biomechanics, Hypertension, Insulin Resistance, Diabetes, Diabetes Mellitus ,Wounds, Diabetes Complications, Hyperbaric Oxygenation, Diabetic Foot Ulcers
Department of Clinical Sciences, Lund Assistant head of department
Department of Clinical Sciences, Lund, Diabetes lab, Project Manager, EpiHealth: Epidemiology for Health
Sahlgrenska University Hospital
Dr. Stig Attvall is currently working at Sahlgrenska University Hospital, Sweden. His international experience includes various programs, contributions and participation in different countries for diverse fields of study. His research interests reflect in his wide range of publications in various national and international journals.
Group Leader, Clinical Database Management.
Colleen E. Mdingi is the Group Leader, Clinical Database Management. She has over 15 years’ experience in research and clinical and most recently was part of the team who developed a novel CGM implantable medical device which received FDA approval. Since 2003, she worked in the medical device industry at Senseonics, Inc. Starting in the signal processing/algorithm departments she help analyze study data and develop the first glucose algorithm used by the CGM system. Currently she is part of the clinical team, overseeing all data management activities. She received a Bachelor of Arts in Physics from Western Maryland College and a M.S. in mechanical engineering from Virginial Polytechnic Institute.
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.