title: Multisite Study of an Implanted Continuous Glucose Sensor Over 90 Days in Patients With Diabetes Mellitus.
abstract: BACKGROUND
  Continuous glucose monitoring (CGM), which enables real-time glucose display and trend information as well as real-time alarms, can improve glycemic control and quality of life in patients with diabetes mellitus. Previous reports have described strategies to extend the useable lifetime of a single sensor from 1-2 weeks to 28 days. The present multisite study describes the characterization of a sensing platform achieving 90 days of continuous use for a single, fully implanted sensor.
  
  
  METHODS
  The Senseonics CGM system is composed of a long-term implantable glucose sensor and a wearable smart transmitter. Study subjects underwent subcutaneous implantation of sensors in the upper arm. Eight-hour clinic sessions were performed every 14 days, during which sensor glucose values were compared against venous blood lab reference measurements collected every 15 minutes using mean absolute relative differences (MARDs).
  
  
  RESULTS
  All subjects (mean ± standard deviation age: 43.5 ± 11.0 years; with 10 sensors inserted in men and 14 in women) had type 1 diabetes mellitus. Most (22 of 24) sensors reported glucose values for the entire 90 days. The MARD value was 11.4 ± 2.7% (range, 8.1-19.5%) for reference glucose values between 40-400 mg/dl. There was no significant difference in MARD throughout the 90-day study (P = .31). No serious adverse events were noted.
  
  
  CONCLUSIONS
  The Senseonics CGM, composed of an implantable sensor, external smart transmitter, and smartphone app, is the first system that uses a single sensor for continuous display of accurate glucose values for 3 months.
authors.affiliation: Senseonics, Inc, Germantown, MD, USA andy.dehennis@senseonics.com.
authors.forename: Andrew
authors.initials: A
authors.lastname: Dehennis
authors.affiliation: Senseonics, Inc, Germantown, MD, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Mortellaro
authors.affiliation: Carol Davila University, Faculty of General Medicine and Elias Emergency University Hospital, Bucharest, Romania.
authors.forename: Sorin
authors.initials: S
authors.lastname: Ioacara
mesh_terms: D000328:Adult; D000368:Aged; D015374:Biosensing Techniques / Q000295:instrumentation; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D004867:Equipment Design; D005260:Female; D006801:Humans; D007332:Insulin Infusion Systems; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000295:instrumentation*; D055815:Young Adult
chemical_list: D001786:Blood Glucose
keywords: continuous glucose monitoring; diabetes mellitus; fluorescent sensor; hypoglycemia alarms; implantable sensors; wearable device