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.
RCT Entities:
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.
Authors: Richard M Bergenstal; William V Tamborlane; Andrew Ahmann; John B Buse; George Dailey; Stephen N Davis; Carol Joyce; Tim Peoples; Bruce A Perkins; John B Welsh; Steven M Willi; Michael A Wood Journal: N Engl J Med Date: 2010-06-29 Impact factor: 91.245
Authors: William V Tamborlane; Roy W Beck; Bruce W Bode; Bruce Buckingham; H Peter Chase; Robert Clemons; Rosanna Fiallo-Scharer; Larry A Fox; Lisa K Gilliam; Irl B Hirsch; Elbert S Huang; Craig Kollman; Aaron J Kowalski; Lori Laffel; Jean M Lawrence; Joyce Lee; Nelly Mauras; Michael O'Grady; Katrina J Ruedy; Michael Tansey; Eva Tsalikian; Stuart Weinzimer; Darrell M Wilson; Howard Wolpert; Tim Wysocki; Dongyuan Xing Journal: N Engl J Med Date: 2008-09-08 Impact factor: 91.245
Authors: Satish K Garg; James Smith; Christie Beatson; Benita Lopez-Baca; Mary Voelmle; Peter A Gottlieb Journal: Diabetes Technol Ther Date: 2009-02 Impact factor: 6.118
Authors: Roy W Beck; Bruce Buckingham; Kellee Miller; Howard Wolpert; Dongyuan Xing; Jennifer M Block; H Peter Chase; Irl Hirsch; Craig Kollman; Lori Laffel; Jean M Lawrence; Kerry Milaszewski; Katrina J Ruedy; William V Tamborlane Journal: Diabetes Care Date: 2009-08-12 Impact factor: 19.112