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36
| 1 | 2006
Klinisk Biokemi i Norden
Background
In order to give reimbursement for glucose test
strips in Norway, The National Social Insurance
Office (Rikstrygdeverket) instructs the companies to
carry out an evaluation that includes a user-evalua-
tion among diabetics. The evaluation results must
fulfil the quality goals set in ISO 15197.
OneTouch Ultra and OneTouch GlucoTouch are
meters designed for glucose self-measurements by
diabetics. The meters are produced by LifeScan,
Johnson & Johnson, and are supplied in Scandinavia
by LifeScan. OneTouch Ultra was launched onto
the Norwegian market in the autumn 2002 and
GlucoTouch was launched in 1996. The evaluations
were done under the direction of SKUP during the
spring of 2005.
The aim of the evaluation
The aim of the evaluation is to
- reflect the analytical quality under standardised
and optimal conditions, performed by biomedical
laboratory scientists
- reflect the analytical quality achieved by the users
(160 diabetic patients participated in the two
evaluations)
- compare the analytical quality among diabetics
with and without training
- compare the analytical quality among diabetics
before and after three weeks of practise
- check the variation between three lots of test
strips
- examine if hematocrit interferes with the measu-
rements
- evaluate the user-friendliness of the device
- evaluate the user-manual
Materials and methods
Approximately 80 diabetics took part in each eva-
luation. One group of participants had two consul-
tations (the “training group”) and the other group
had one consultation (the “post group”). At the first
consultation the diabetics in the “training group”
were given a standardised instruction about the
OneTouch Ultra or the GlucoTouch device before
they did a finger prick and performed two measu-
rements on the meter. The biomedical laboratory
scientist also took capillary samples of the diabe-
tics and measured twice at the device. In addition,
two capillary samples were taken to a designated
comparison method. The “post group” received the
device by post and no training was given. Both
groups of diabetics carried out a practice period of
three weeks at home, before they were called for a
second consultation. The same blood glucose samp-
ling and measurement procedures 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 finally answered
questionnaires about the user-friendliness and the
user-manual.
Results, OneTouch Ultra
OneTouch Ultra shows acceptable precision. The CV
is < 5 % under standardised and optimal measuring
conditions and between 2 and 6 % when the mea-
surements are performed by diabetics.
The agreement with a designated comparison
method is good. Quality goals set in ISO 15197
are achieved, both under standardised and optimal
measuring conditions and by the diabetic patients.
The three lots of test strips showed significantly
ONETOUCH Ultra Glucose
ONETOUCH GlucoTouch Glucose
Av Grete Monsen, SKUP (grete.monsen@isf.uib.no)
Summary of two evaluations organised by SKUP
Report SKUP/2005/39 and SKUP/2005/40
