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38
| 2 | 2008
Klinisk Biokemi i Norden
Background
In order to give reimbursement for glucose test
strips in Norway, the Norwegian Labour and Welfare
Organisation (NAV) requires from the companies
to carry out an evaluation that includes a user-
evaluation among diabetes patients. The results of
the evaluation must fulfil the quality goals set in ISO
15197 (TE within ±20 %).
Ascensia Breeze2 and FreeStyle
Lite
are meters
designed for glucose self-measurements by diabetes
patients. Ascensia Breeze2 is produced by Bayer
HealthCare and supplied in Scandinavia by Bayer.
FreeStyle
Lite
is produced by Abbott Diabetes Care
Inc. and supplied in Scandinavia by Abbott. Ascensia
Breeze2 and FreeStyle
Lite
were launched onto the
Norwegian market in October 2007. The evaluation
of Ascensia Breeze2 was carried out during the
autumn of 2006, and the evaluation of FreeStyle
Lite
during spring 2007.
The aim of the evaluations
The aim of the evaluations is to
- reflect the analytical quality under standardised and
optimal conditions, performed by biomedical labo-
ratory scientists in a hospital environment
- reflect the analytical quality achieved by the inten-
ded users (approximately 160 diabetes patients
participated in the two evaluations)
- compare the analytical quality among trained and
un-trained diabetes patients
- compare the analytical quality among diabetes
patients before and after three weeks of practice
- check the variation between three lots of test strips
Ascensia Breeze2 Glucose
FreeStyle
Lite
Glucose
Av Grete Monsen, SKUP (grete.monsen@noklus.no)
Summary of two evaluations organised by SKUP
Report SKUP/2007/59 and SKUP/2007/64
- examine if hematocrit interferes with the glucose
measurements
- evaluate the user-friendliness of the device
- evaluate the user guide
Materials and methods
Approximately 80 diabetes patients took part in each
evaluation. Half of the diabetes patients had two
consultations (the “training group”) and the rest of
them had one consultation (the “mail group”). At the
first consultation the diabetes patients in the “training
group” were given a standardised instruction about
the device before they did a finger prick and perfor-
med two measurements on the meter. The biomedical
laboratory scientist also collected capillary samples
from the diabetes patients and measured twice on the
device. In addition, two capillary samples were taken
for measurements with a designated comparison
method. The diabetes patients in the “mail group”
received the device by mail and no training was given.
Both groups of diabetes patients used the equipment
for approximately three weeks at home, before they
were called for a final consultation. The blood glucose
sampling and measurement procedures at the first
consultation were repeated, and in addition a sample
for hematocrit was taken. Three different lots of test
strips were used in the evaluation. All the participants
answered questionnaires about the user-friendliness
and the user guide.
Results, Ascensia Breeze2
The precision of Ascensia Breeze2 was good. The
repeatability CV was approximately 3 % under stan-
