Professional / lay user evaluation, System assays from the lay user’s fingerstick, Ontour – Bayer HealthCare Ascensia Contour Blood Glucose Monitoring System User Manual

Page 29

Advertising
background image

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

Advertising