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THE PHARMA REVIEW (SEPTEMBER 2009)

Diabetic Diagnostics: A Comprehensive Review

Dr. Papiya Bigoniya, Mr. Alok Shukla, Mr. C.S. Singh

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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