Accuracy performance of the Medtronic NexSensor™ for 6 days in an inpatient setting using abdomen and buttocks insertion sites

J Diabetes Sci Technol. 2011 Mar 1;5(2):358-64. doi: 10.1177/193229681100500224.

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.

Conclusion: 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdomen / pathology*
  • Adolescent
  • Adult
  • Aged
  • Blood Glucose / analysis
  • Blood Glucose Self-Monitoring / instrumentation*
  • Blood Glucose Self-Monitoring / methods*
  • Buttocks / pathology*
  • Calibration
  • Diabetes Mellitus, Type 1 / blood
  • Female
  • Humans
  • Male
  • Middle Aged
  • Monitoring, Ambulatory / methods
  • Reproducibility of Results
  • Time Factors

Substances

  • Blood Glucose