FreeStyle Navigator(R) - Proven Accuracy

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%.

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.

Superior event 3 detection and alarm performance 4
| Successful event detection | Reliable alarm performance7 |
|
|
| 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 |
Call us 24 hours a day, 7 days a week: 1-866-597-5520
DOC13788_Rev-A 01/08
