FreeStyle Navigator(R) - Proven Accuracy

FreeStyle Navigator Receiver

Proven highly accurate on the Clarke1
and Consensus2 error grids

The median absolute relative difference is 9.3% and the mean absolute relative difference is 12.8%.

Clarke Graph

Definition of Clarke Error Grid
A: Clinically accurate; would lead to correct and safe treatment
B: Benign Error; would lead to benign decisions or no treatment decisions
C: Overcorrection; would lead to overcorrection of normal glucose levels
D: Failure to detect; would lead to failure to detect and treat high or low glucose levels
E: Errors; would lead to erroneous treatment decisions

Study Design:
The FreeStyle Navigator In-Clinic Study was a multicenter, prospective, nonrandomized study to evaluate the accuracy of FreeStyle Navigator compared with a standard laboratory-reference method, the YSI blood glucose analyzer. Each of the 58 subjects wore 2 sensors: 1 on the arm and 1 on the abdomen over a 5-day period.

The FreeStyle Navigator® system is highly accurate and precise

The sensor reproducibility (Coefficient of Variation) is 10% as measured between the arm and abdomen.

FreeStyle Navigator Sytem Accuracy

Superior event 3 detection and alarm performance 4

 
Successful event detection Reliable alarm performance7
  • 96.0% hypoglycemic events detected by glucose alarms and readings5
  • 99.8% hyperglycemic events detected by glucose alarms and readings6
  • 79.8% of hypoglycemic events detected by glucose alarms alone
  • 79.2% of hyperglycemic events detected by glucose alarms alone
 
 
1   Clarke W.L. et.al. Evaluating clinical accuracy of system for self-monitoring blood glucose. Diabetes Care 1987; 10:622-628
 
2 Parkes J.L. et.al.A new consensus error grid to evaluate the clinical significance of inaccuracies in the measurement of blood-glucose. Diabetes Care 2000; 23:1143-1148.
 
3 Events are defined as being > 15 minutes.
 
4 Data on file, Abbott Diabetes Care Inc.
 
5 Readings are within 15 mg/dL of the YSI value. Alarm threshold was set to 70 mg/dL
 
6 Readings are within 20% of the YSI value. Alarm threshold was set to 240 mg/dL
 
7 Alarm performance includes early-warning alarms
 
 
 
 
 

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DOC13788_Rev-A 01/08