Advice Pool - Health and Fitness

Monitoring Your Blood Glucose Levels

For every diabetic monitoring your own blood glucose (sugar) levels can be vitally important in controlling your diabetes. The cur

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

rent treatments in diabetes whether medicines or diet focus on trying to keep blood glucose levels as close to normal as possible.

There are two main ways to monitor t

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

he body's glucose levels, testing for blood glucose and testing for urine glucose. Both methods have their advantages and disadvantages. Which method you choose depends

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

on what your doctor advises you.

Blood Glucose Meters

Testing blood glucose levels has become very simple and very accessible thanks to a whole range of blood glucos

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

meters on the market. Checking glucose in this way is the most accurate method. This is especially important for patients with Type 1 Diabetes (Insulin dependent) and

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

some patients with Type 2 Diabetes requiring insulin. This is because some these patients can make adjustments to their insulin dose depending on the blood glucose test

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

results. Also patients with diabetes may experience very low blood glucose levels called "hypoglycaemia" or very high blood glucose levels called "hyperglycaemia". Oft

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

n there are signs and symptoms of both. Using a blood glucose meter to get an exact reading can help reassure or confirm that action must be taken.

How Does A Blood Gl

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ucose Meter Work?

The 2 main meters on the market at present are Accu-chek Aviva and One Touch Ultra. Both meters use the same basic principle. A blood sample is taken

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

usually from the finger using a finger pricking device. The sample is placed on a specially coated test strip which is then inserted into the blood glucose meter. With

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

n a minute the meter will give you a result. The main drawback of this method is that it does require pricking your finger each time to take a blood sample. This for so

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

me can be nuisance. However, with recent advances in meter technology the amount of blood required for Accu-chek Aviva and One Touch Ultra is minimal. This in turn lead

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

s to less pain when pricking the finger.

Urine Testing

Urine strips have the advantage of being pain free but the disadvantage of not bring as accurate as a blood glu

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

cose meter.

For some, urine testing is a more then adequate method to test glucose especially for diabetics who do not need exact blood glucose levels. Glucose only ap

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ears in the urine (for most people) when glucose levels in the blood reaches above 10 mmol/L (180 mg/dl). At this point the kidney can no longer reabsorb all the glucos

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

e being filtered and glucose appears in the urine. If you blood glucose levels are below 10 mmol/L (180 mg/dL) then urine test strips will not provide a result. Thus al

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ways use a blood glucose meter when testing for low blood glucose levels (hypoglycaemia) as it will give you an accurate reading regardless of what your blood glucose i

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

.

How To Use Urine Testing Strips

The main two makes of glucose testing strips are Clinistix

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

> and Diastix. Click on Clinistix to learn more about how to use the urine strips.

Interpreting Your Results

How you interpret your results depends very much on the g

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

oals your doctor has set out for you and what you are testing for. A key point to remember is that blood glucose levels will be affected by food and diabetic medication

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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Advice Pool - Blood Glucose Meters or Urine Test Strips - Which You Should Choose To Monitor Your Diabetes

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