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Abstract: People with diabetes are at greater
risk of developing microvascular and macrovascular
complications like hypertension, heart attacks,
blindness and kidney failure. Self-monitoring of blood
glucose is an essential part of a successful diabetes
management program to adjust and access the response of
therapy which ensures adequately control glucose levels
round the clock. The glucose testing market is
increasing at approximately 12%-15% per year with the
increases in patient population frequently practicing
self testing. Glucometer are very handy device for quick
testing of glucose in blood droplets. Continuous glucose
monitoring systems are also in use for patients in need
for intensive control of glucose level. Now-a-days
implantable glucose sensors are under development to
measure interstitial glucose every few minutes
automatically, without any user intervention.
New medical devices are developing continuously, so
proper installation, preventive maintenance, rational
use, and verification of safety and efficacy with
quality assurance are to be controlled. WHO is currently
developing a series of tools, guidelines and
informations to enhance the best use of medical device.
FDA reviews all glucose meters and test strips before
marketing by post-marketing approval application
containing valid scientific evidence on accuracy and
consistency of measurement. The In-Vitro Diagnostics
guidelines require device manufacturers to supply the
Instructions For Use and precaution to be taken while
using in all required languages. A number of reports
signifies adverse incidents in glucose meters changing
units of measurement from mmol/L to mg/dl. Improvements
in the chemical, mechanical and software components of
glucose meters are continuing to help with the
management of diabetes.
Introduction
Diabetes is a chronic metabolic disease that affects the
pancreas’s ability to produce or respond to insulin.
Diabetes requires continuing medical care and patient
self-management education to prevent acute complications
and to reduce the risk of long-term complications. The
number of people with diabetes is increasing due to
population growth, aging, urbanization and increasing
prevalence of obesity, and physical Inactivity.
According to World Health Organization (WHO) at least
171 million people worldwide have diabetes. Around 3.2
million deaths every year are attributable to
complications of diabetes; six deaths every minute. If
not checked, an estimated 360 million people worldwide
are expected to get diabetes by 2030, with the largest
increase occurring in the developing countries. The top
10 countries, in numbers of sufferers are India, China,
USA, Indonesia, Japan, Pakistan, Russia, Brazil Italy
and Bangladesh.
The International Diabetes Federation (IDF) also
reported that the total number of diabetic subjects in
India was 41 million in 2006 and that this would rise to
70 million by the year 2025 causing a heavy strain on
the country’s health sector. The WHO has predicted that
every fifth person in the world with diabetes will be an
Indian. There are nearly 2.5 to 3 crores patients of
diabetes in India.
People with diabetes are at greater risk of developing
arterial hypertension, heart attacks, blindness and
kidney failure. Diabetic retinopathy is a leading cause
of blindness and visual disability. Diabetes is among
the leading causes of kidney failure. Diabetic foot
disease, due to changes in blood vessels and nerves,
often leads to ulceration and subsequent limb
amputation.
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