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| 1 | 2005
Klinisk Biokemi i Norden
Ascensia Contour Glucose
Av Grete Monsen, SKUP (grete.monsen@isf.uib.no)
Summary of an evaluation organised by SKUP
Report SKUP/2004/30
Background
Acsensia Contour is a meter designed for glucose
self-measurements by diabetic patients. The meter
is produced by Bayer HealthCare and is supplied in
Scandinavia by Bayer. Ascensia Contour was laun-
ched onto the Norwegian market in the autumn of
2003. In order to give reimbursement for glucose
test strips in Norway, The National Social Insurance
Office instructs the companies to carry out an eva-
luation that includes a user-evaluation among dia-
betic patients. The evaluation of Ascensia Contour
was done under the direction of SKUP during the
spring of 2004.
The aim of the evaluation
The aim of the evaluation of Ascensia Contour was
to
- reflect the analytical quality under standardised
and optimal conditions (performed by two bio-
medical laboratory scientists) and by the users
(app. 75 diabetic patients)
- compare the analytical quality before and after
training and practice
- examine if hematocrit affects the glucose measu-
rements
- check the lot-variation of test strips
- evaluate user-friendliness and the user manual
Materials and methods
76 diabetic patients took part in the evaluation.
Three different lots of test strips were used. All par-
ticipants met twice at NOKLUS. At the first consul-
tation the patients did a finger prick and performed
two measurements on the Ascensia Contour meter,
without further instructions. The biomedical labo-
ratory scientist also took capillary samples of the
diabetic patients and measured twice at Ascensia
Contour. In addition, two capillary samples were
taken to a designated comparison method. Then
the diabetics were given a standardised instruction
about the Ascensia Contour meter. In a practice
period of approximately three weeks the diabetics
used the meters at home, before they were called
for a second consultation. The blood sampling and
measurement procedures were repeated, and in
addition a sample for hematocrit was taken. Finally,
the diabetic patients filled in questionnaires about
user-friendliness of the meter and about the user
manual.
Results
- Ascensia Contour showed acceptable precision.
The CV was < 5 % under standardised and opti-
mal measuring conditions and approximately 5
% when the measurements were performed by
diabetic patients.
- The agreement with a designated comparison
method was good on certain conditions. Quality
goals set in ISO 15197 (± 20 %) and by ADA
(± 10 %) were achieved under standardised and
optimal measuring conditions when using the
first measurement of paired results. The second
measurement in the pair was systematic higher
than the first. When handled by the diabetic
patients, Ascensia Contour showed good results
initially and the quality goal set by ISO was
attained. After three weeks of use at home the
results were not as good as the initial ones. Only
80 % of these results were within the quality
goals set by ISO and 90 % were within an “adjus-
ted ISO-goal”. It is not clear why these results did
not meet the quality goals.
- The three lots of test strips showed no clinical
significant bias from the comparison method.
- Glucose measurements on Ascensia Contour
seemed to be affected by the hematocrit values
of the samples in a higher degree than described
in the package insert. The glucose values were
