| |
 |
The continually evolving Glucocard |
ARKRAY and its history with SMBG
It is no exaggeration to say that the history of
ARKRAY mirrors the changes in SMBG meters. In the 1960s
it was Eyetone from ARKRAY that enabled blood glucose test
strips developed in USA to be measured in small devices
and this was a world first. The term small may seem a little
misleading because these small meters were not like the
small meters of today, fitting into a breast pocket. They
were about the size of two video cassettes stacked in top
of each other. On top of this the display was not digital
like we see today, but an analogue meter using a needle
gauge. Reagent reaction time was two minutes and after that,
the user had to wash the reagent and carefully wipe away
the water. By the standards of today, this is hardly something
that we would call quick and simple.
|
|
Simple Blood Glucose Meter EYETONE(1970)
|
| ARKRAY then succeeded in developing an easy-wipe film
test strip as well as shortening the reaction time from
2 to 1 minute. Advances were made in changing over to a
digital display and scaling down the size. In 1989 the first
breast pocket-sized unit, the Toecho III, was developed.
As ARKRAY moved into the 1990s the switch began to be made
from the color comparison method to enzymatic/electrode
methods, eventually leading to the current Glucocard that
you can see today. |
Color comparison or electrode method?
The different generations of the SMBG can be categorized
as below:
|
| First generation |
Washing and wiping type test strip (enzymatic
color comparison)
Visual check was possible but results varied according to
the operator's technique. |
| Second generation |
Non-wipe, enzymatic color comparison test strips
Cleaning and wiping were no longer required and the operator's
technique ceased to be such a great source of disparity. |
| Third Generation |
Current generated from chemical
reaction is measured under the enzymatic electrode method.
(Present)This is the main type of measurement method used
currently. |
| Fourth generation:
|
Non-invasive method requiring no
blood sampling.
(Future)Research continues into near infrared method and
a method using intercellular fluid. |
Within the above classification of SMBG
generations, it is also correct to say that the step between
the second and third stages was significant. The advantage
of the color comparison system was that even if the system
broke, a visual measurement could still be performed and
a rough result obtained although the process of cleaning
and wiping was a troublesome necessity.
Yet, if the machine using the electrode method failed, there
was no way for the patient to know the result of their test.
On the other hand it required no cleaning and wiping and
was simpler and easier to use.
There was much debate within the company as to whether we
should continue with the color comparison method or move
into the electrode method. We eventually settled on the
electrode method because the system rarely failed. This
was the beginning of the first incarnation of the Glucocard
that you can see today.
The last model adopting
enzymatic color comparison method
GLUCOSCOT III GT-4330(1989) |
|
The first model adopting
enzymatic electrode method
GLUCOCARD GT-1610(1991) |
The Glucocard became a big hit and its ease of use and reliability
resulted in support from medical professionals and patients.
In 1986 self blood glucose measurement for patients who
injected themselves with insulin became covered by insurance
and this partly led to the level of recognition that made
it the de facto standard for SMBG in Japan.
Amongst our competitors, there are those who, since the
early 1990s have used over 4 different platforms (compatible
reagents) for both the color comparison and electrode methods.
However, only ARKRAY were able to reduce measurement time
and the volume of patient sample on the same platform. There
were many model changes but the measurement operation has
been the same as it was in the first model. This is probably
one of the factors that earned it its reputation amongst
users as a reliable instrument.
And finally
In 2003 an international standard governing SMBGs came into
effect in the form of ISO-15197. In a 2005 amendment to
Japanese pharmaceutical law, it was judged that SMBGs posed
a high risk for patients using them unaided and just as
with contact lenses and pacemakers, they were classified
as highly controlled medical device (Class iV) and Specially
Designated Maintenance Required Medical Device. In addition,
in 2007, acceptance criteria for SMBG under pharmaceutical
law were issued.
As such, the environment in which the SMBG exists is ever-evolving.
In the face of increasingly tough standards, we are constantly
challenging ourselves to make devices that improve patients'
quality of life and we will keep Glucocard evolving |
|
