Tuesday, August 03, 2004


Improving Blood Glucose Monitoring for Diabetes

Improving Blood Glucose Monitoring for Diabetes with Blood Glucose Analyzers

When most people sit down for lunch, the only guidance they seek is from the
menu. But for an estimated 1 million Americans who are diagnosed with Type I
diabetes mellitus, lunch--or any other meal--starts with a test using a
portable device called the blood glucose meter.

Self-monitoring of blood glucose (a sugar) is called SMBG for short. Most
insulin-dependent diabetics carry out SMBG four to seven times a day, as it is
crucial to treatment of the potentially degenerative disease of diabetes.
Properly executed, SMBG enables the users to modify the type of food they eat,
vary the amount and time of exercise, and adjust medications. SMBG, which is
also recommended for some diabetics who have non-insulin-dependent diabetes
(known as Type II), enables the physician and patient to clearly define
treatment goals and to measure the effectiveness of therapy with minimum
disruption of daily life.

Yet, some diabetics have had difficulty following the procedures involved with
self-monitoring of blood glucose. Complaints, which started reaching the Food
and Drug Administration's Center for Devices and Radiological Health in the
mid-80s, raised questions about the accuracy of blood glucose readings
obtained by diabetics at home, and caused concern about the impact on
treatment regimens. For the past three years, FDA has been trying to find out
why errors occur in SMBG--and the search is now almost finished.

Major Advance

Diabetes, which in some forms is genetically linked, reduces the level of
insulin needed to deliver energy-rich glucose to the cells of the body. In
its mildest form, Type II diabetes can go practically unnoticed--an estimated
5 million American diabetics have never been diagnosed and are presumably
unaware of their illness or of the long-term health consequences. But the
most severe type of diabetes mellitus, Type I, characterized by insulin
dependence, can lead to blindness, gangrene of the extremities, kidney
dysfunction, arteriosclerotic heart disease, and, if these complications are
untreated, death.

For the 10 percent of America's 11 million diabetics--and a similar proportion
of the 200 million diabetics worldwide--who closely watch their glucose
levels, blood glucose meters represent a major advance. Traditionally, a
urine test strip was used at home by diabetics to monitor glucose levels.
However, its results were indirect, measuring spillover of sugar in the urine,
and for Type I diabetics it was of only limited use for total diabetes
management. Generally, only high glucose levels could be detected.

Blood glucose measurements were introduced for home use in the late 1960s,
enabling diabetics to detect high and low blood sugar levels by visually
noting color changes on a chemical test strip from a single drop of blood.

By the late 1970s, the evolution to a portable meter to "read" the chemical
strips was complete, and a new trend in diabetes management was born. The
blood glucose meters, sold over the counter in pharmacies and grocery stores
today, detect the glucose level in the blood on the strip and provide
immediate warning about the onset of hyper- or hypoglycemia (high or low blood
sugar). Experts agree that measuring glucose in the blood is a more preferred
method than measuring it in the urine.

Moreover, the meters include many features designed to make self-monitoring
convenient. Many operate on batteries and are small enough to fit in a purse
or a shirt pocket and can be used almost anywhere. Some contain electronic
memory, and more advanced models even have built-in modems for transmitting
the test results to the diabetic's physician.

The Procedure

With most of the meters, the process of SMBG takes just a few minutes. For
some meters, the first step is to calibrate the meter for the particular batch
of test strips being used. Then, as with the use of visual test strips, the
user obtains a drop of blood by pricking a clean finger with a puncture device
and places that drop of blood on the chemically treated pad of a testing
strip. The user starts the meter, which measures the exact time necessary for
the chemicals in the pad to react to the blood. Several seconds later, the
meter alerts the user to blot or wipe the excess blood from the pad of the
test strip. At another signal from the meter, the user inserts the strip in
the meter. Shortly afterward, the display window shows the glucose level in
the blood. Some older SMBG systems require wiping or blotting of blood from
the test strips, but new technology has eliminated this step from the
procedure. For these new meters, once the blood is placed on the test area,
the meter times the reaction and delivers a glucose reading.

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