Advice Pool - Health and Fitness

Regular blood glucose testing by people with diabetes is important to help control it, and also prevent long-term complications. Good control of blood glucose levels can prevent or reduce serious complications.

Frequent testing can show how changes in diet, exercise, m

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

edications or weight are having an effect on a patient's diabetes. Close monitoring of blood glucose levels allows control and timely intervention to prevent diabetic complications.

Why is testing important for diabetic patients?

Regular monitoring of blood sugar leve

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

Examples of combination products may in

s (blood glucose) gives valuable information as to whether the level is within the normal range. If kept in control, this can delay the onset or development of long term diabetic complications, which can even be life-threatening.

People with type 1 and type 2 diabetes

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

an monitor their blood sugar themselves, by using thumb prick blood tests which are available as home kits. Self-monitoring is very important for long-term health. What are the routine tests that are followed?

Regular self testing, recording of blood glucose levels by

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

thumb prick blood tests, laboratory test of HbA1c (glycosylated haemoglobin) level a few times a year should be taken. Other tests that should be performed routinely include: urine test to monitor kidney function; blood fat levels (cholesterol & triglyceride levels), a

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

Combination pro

d tests for kidney function. Regular blood pressure measurement and treatment if needed.

Examination of the feet is also necessary, as the patient may not be aware of loss of sensation from early nerve damage.

Also, get eyes tested every 1 to 2 years, depending on te

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

st results. How is diabetes and pre-diabetes diagnosed?

The following test are the normal tests whoich are used for diagnosis:

1. Fasting plasma glucose test – This measures the blood glucose with a minimum gap of at least 8 hours without eating. It is best done on

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

an empty stomach in the morning. This test is used to detect diabetes or pre-diabetes. If a person’s fasting glucose level is 100 to 125 mg/dL, you have a form of pre-diabetes called impaired fasting glucose (IFG), meaning that one is quite likely to develop type 2 dia

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

etes but does not have it yet. A level of 126 mg/dL or above, confirmed by repeating the test on another day, means that one is diabetic.

99 mg/dL and below – normal, not diabetic
100 mg/dL to 125 mg/dL – pre diabetic
126 mg/dL and above – diabetic.

2. Ora

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

glucose tolerance test (OGTT) –

This measures the blood glucose after one has not eaten for least 8 hours, and then 2 hours after drinking 75 grams glucose-containing beverage. This test is used to diagnose diabetes or pre-diabetes. This test is more sensitive than t

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

e fasting plasma glucose test for diagnosing pre-diabetes. If 2 hours after drinking the liquid, the blood glucose level of a person is between 140 and 199 mg/dL, then it a form of pre-diabetes called impaired glucose tolerance or IGT, meaning that one is more likely t

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

Following aspects would a

o develop type 2 diabetes but does not have it yet.

Glucose level of 200 mg/dL or above, confirmed by repeating the test on another day, means that one has diabetes.

139 mg/dL and below – not diabetic, normal
140 mg/dL to 199 mg/dL – pre diabetes
200 mg/dL a

dd to the challenges in developing combination products:

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

d above - diabetic

Gestational diabetes is diagnosed based on plasma glucose values measured during the OGTT. Blood glucose levels are checked four times during the test. If the blood glucose levels are above normal at least twice during the test, then the person has g

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

stational diabetes.

3. Random plasma glucose test –

This measures blood glucose without regard to when you ate your last meal. This test, along with an assessment of symptoms, is used to diagnose diabetes, but not pre-diabetes.

A random blood glucose level of 200 mg/

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

L or more, alongwith presence of the following symptoms, can suggest that one has diabetes:
· increased urination
· increased thirst
· unexplained weight loss

Other associated symptoms include fatigue, blurred vision, increased appetite, and sores that

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

do not heal. Test results are confirmed only after repeating the fasting plasma glucose test or the oral glucose tolerance test on a different day.

What is HbA1c or the glycosylated haemoglobin test?

HbA1c (glycosylated haemoglobin) gets collected in red blood cells

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

Professional from academic institutions, pharmaceutical industries, health care indust

when they are produced. This gives a clue about the blood sugar levels over a couple of months - the average lifespan of a red blood cell. Thus, this test shows the average blood glucose level over time, as compared to the thumb prick test, which indicates blood glucos

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

at the time of testing. If the HbA1c level is above 7%, consult a doctor for a better diabetes management plan. If the HbA1c level is above 8%, the doctor may change medication or a more intensive insulin regime be used. The combination of HbA1c test and thumb prick

.

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

test results give a better indication of variations in blood glucose levels than either test alone.

How often should blood sugar testing be done?

Diabetic patients who are taking insulin injections should self test 3-4 times everyday, especially before retiring to bed

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

Companies that provide selfless information through particip

Type 2 diabetic patients on medicines should self test around a few times every week. It is best to check glucose levels first thing in the morning; and before and after meals. Keep changing daily test times to get a better idea of the changes to blood glucose levels

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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