title: Accuracy performance of the Medtronic NexSensor™ for 6 days in an inpatient setting using abdomen and buttocks insertion sites.
abstract: BACKGROUND
  Users of continuous glucose monitoring are concerned with product accuracy and choice of insertion site. The Medtronic NexSensor™ was evaluated for accuracy during 6 days of wear when inserted in the abdomen and buttocks areas.
  
  
  METHODS
  Adults (ages 18-75) with type 1 diabetes wore two sensors simultaneously for 6 days, one each inserted in the abdomen and buttocks. Subjects underwent a frequent blood sampling study for 12 hours, during which time reference blood glucose values were obtained every 15 minutes and compared to sensor values.
  
  
  RESULTS
  Sixty-three subjects were enrolled, and 61 subjects completed the study. The mean agreement rate between sensor and blood glucose values was 75.5% [95% confidence interval (CI), 69.5, 81.4] at the abdomen site, 73.8% (95% CI, 68.8, 78.8) at the buttocks site, and 75.6% (95% CI, 70.8, 80.4) when sensor and reference data were combined between sites. Over 90% of paired sensor-reference values on Clarke error grids were within the A and B ranges. The mean absolute relative differences were 17.1% at the abdomen site, 16.5% at the buttocks site, and 16.8% when sites were combined.
  
  
  CONCLUSIONS
  The NexSensor was accurate for inpatient, frequent-sample testing for 6 days when inserted into the abdomen and buttocks. The results of this study also provide evidence that both the abdomen and buttocks are suitable as sensor insertion sites.
authors.affiliation: Medtronic, Inc., Goleta, California 93117, USA. tim.peoples@medtronic.com
authors.forename: Tim
authors.initials: T
authors.lastname: Peoples
authors.forename: Timothy
authors.initials: T
authors.lastname: Bailey
authors.forename: Brazg
authors.initials: B
authors.lastname: Ronald
authors.forename: Howard C
authors.initials: HC
authors.lastname: Zisser
authors.forename: Bob
authors.initials: B
authors.lastname: Janowski
authors.forename: Suiying
authors.initials: S
authors.lastname: Huang
authors.forename: Cary
authors.initials: C
authors.lastname: Talbot
authors.forename: Qingqing
authors.initials: Q
authors.lastname: Yang
mesh_terms: D000005:Abdomen / Q000473:pathology*; D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000379:methods*; D002081:Buttocks / Q000473:pathology*; D002138:Calibration; D003922:Diabetes Mellitus, Type 1 / Q000097:blood; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018670:Monitoring, Ambulatory / Q000379:methods; D015203:Reproducibility of Results; D013997:Time Factors
chemical_list: D001786:Blood Glucose