Professional / lay user evaluation, System assays from the lay user’s fingerstick, Ontour – Bayer HealthCare Ascensia Contour Blood Glucose Monitoring System User Manual
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2. Professional / Lay User Evaluation
A Patient Use evaluation was conducted at two diabetes
clinics. Lay users with diabetes were given product
instructions with no training. After reviewing the instruc-
tions, the users performed fingersticks and glucose assays
using the Ascensia C
ONTOUR
System. Two reagent lots were
evaluated at each clinic; one was common to both sites. After
the user’s self test, the attending HCP performed Ascensia
C
ONTOUR
System assays from the lay user’s fingerstick.
25
95% Confidence Interval
n
y =
Slope
/
Intercept
r
746
1.01x – 8.42
1.00 to 1.02 –10.05
to –7.00 0.992
0
100
200
300
400
500
600
0
100
200
300
400
500
600
YSI Plasma Glucose Result (mg/dL)
Ascensia
C
ONTOUR
Result (mg/dL)
y=x
Passing and Bablok Regression Statistics / Pearson correlation