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In recent years an alternative to manual insulin injections has emerged. Enter the Insulin Pump. The first Insulin Pumps were quite bulky, but modern ones are about the size of a small Cellphone or Pager. The p

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

ump is worn unobtrusively on a belt or in a pocket and it delivers insulin through a thin plastic tube (or Infusion Set) that is inserted under the skin.

WHY AN INSULIN PUMP IS BETTER

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

Examples of combination products may in

In a healthy person, the pancreas produces insulin constantly at low levels, keeping blood glucose levels stable. When a meal is eaten, the pancreas will send larger amounts of insulin into the blood stream t

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

handle the food. Using a standard injection regime, slow and fast acting insulin is used to try and mimic the pancreas. An insulin pump much more closely copies the pancreas. The pump delivers a low level of b

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

ckground insulin (called basal) and at meal times can deliver a "bolus" dose at the touch of a button, to cover the food.

Just like a real pancreas, if you are ill, or exercising, the basal insulin r

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

Combination pro

te can be reduced. If you skip a meal, the bolus is not delivered. In this way, the pump fits into your lifestyle, rather than planning your life around your injection schedule!

CHOOSING AN INSULI

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

PUMP

Most insulin pumps on the market today have all the basic features. Choosing one is much like chosing a Cellphone, it is a mixture of personal taste and what you plan on using it for. I

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

you are a water sports fan, waterproof ones area available! If you love analysing data to improve your control, you can get one with PC download capability and analysis software. If you are new to the worl

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

of Insulin Pumps, here are some key points to think about:

Choose a pump that allows you to set up different basal levels. For instance at night time, if you are sick or exercising. This is an

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

important feature to help you live a full life.

Pumps that use a standard "Luer Lock" infusion sets are better. This means cheaper consumables.

Alerts to remind you to check your blood gluco

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

e level make life easier.

Check what batteries it takes, standard AA or AAAs are cheaper and easier to buy.

More advanced pumps include a carbohydrate calculator to help you figure out what

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

Following aspects would a

your meal Bolus dose should be.

Coming to the market are integrated Insulin Pump/Glucose meters. The meters readings are automatically transferred to the pump which can use them to recommend an insuli

dd to the challenges in developing combination products:

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

dose. Other features to look for include, being waterproof, having a carbohydrate food database and alerts to warn you if you have missed a meal, or the infusion set needs cha

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

ging. In short, Insulin pump manufacturers are making their products ever easier to use and automating more and more features. Life is getting better for diabetics! The latest Insulin pumps are reviewed at

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

ttp://www.diabetesrevealed.com/81Diabetes_reviews_pumps.shtml

FREQUENTLY ASKED QUESTIONS

Q What if I don't get on with the pump, can I switch back to injections?

A Yes. It is not a one

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

ay ticket, but most people do notice an improvement in their blood glucose control and find their lives improved.

Q I have a really hectic lifestyle, is a pump for me?

A Yes. Infact people who

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

Professional from academic institutions, pharmaceutical industries, health care indust

re extremely busy often see the biggest improvement. If you struggle to remember to test and inject at the right time - perhaps meal times vary from day to day, then a pump could really help you.

Q I am

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

considering a pump but may get pregnant, is that ok?
A Yes. As pumps usually improve your blood glucose control, using a pump through pregancy and beyond is generally a good thing. Having as close to n

.

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

rmal blood glucose levels reduces the chances of complications during pregnancy.

Q What are the costs?

A The initial outlay is in the order of a few thousand dollars, but prices are coming down

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

Companies that provide selfless information through particip

all the time. Infusion sets need changing regularly too. The latest prices can be found from various diabetes suppliers on the web.

wwww.diabetesrevealed.com - your online diabetes resource

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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