Insulin Delivery Systems – The Needle, the Pen and the Pump

Insulin is the lifesaver of a type 1 diabetic. Some with type 2 also depend on this hormone to regulate their skyrocketing blood sugar levels. There are techniques to deliver the needed insulin into your body. It can be injected using a fine gauge needle with an insulin syringe. Or, it can be delivered utilizing an insulin pen which is actually a cartridge pre-filled with the medication. The other technique is through a pump system attached outside the body.

The Needle Technique

This technique delivers insulin in individual doses and is injected subcutaneously. You use a fine gauged needle and a syringe with specially marked increments in International Units.

Most diabetics know this technique. After washing your hand, mix the insulin by gently rolling between your hands or by turning the bottle slowly up and down. Clean the rubber stopper with alcohol, pull the plunger back to the number of insulin needed, push the needle through the rubber stopper and push the plunger, leaving the needle and bottle upside down. The tip of the needle should be in the insulin and then extract the right amount of the hormone.

Select the site, pinch the skin to a mound, insert the needle into your skin at a 90 degree angle and then push the plunger slowly down until all the insulin is injected. Then release the pinched skin, wait for some seconds and pull out the needle.

There are two types of insulin therapy that uses the needle technique the conventional and the intensive which is also called flexible insulin regimen.

Conventional insulin therapy uses the rapid- or intermediate-acting. Usually, it is injected twice or thrice daily. Meals are scheduled to match the anticipated peaks of insulin profiles. Frequent blood glucose measurements aren’t done. This method is still in use for a small proportion of cases. There is less needle pricks than the intensive insulin regimen.

Intensive insulin therapy increases the insulin injections to four or more injections a day. Mealtimes are not as rigidly scheduled but can be flexible with variable carbohydrate choices and physical activities.

Obviously, you’ll be using as much as 1,400 needle stick a year. There is the inconvenience of injecting insulin multiple times daily and you have to find a time and place for your insulin injection anywhere you may be.

Blood glucose levels aren’t well controlled in both the conventional and intensive therapy.

The Pen Technique

The pen is a more convenient insulin delivery system. The disposable needle is attached to pen which is actually a cartridge pre-filled with insulin and a dial to measure insulin dose.

The method of using an insulin pen is simple: screw on an unused pen needle, prime the pen to remove any air from the needle, turn the dial to the number of units needed, make a mound in the skin, inset the needle, press the button on the end of the pen to inject the insulin. Count to five and remove the needle straight out.

Apparently, this system is more convenient that the needle technique. It delivers a more accurate dosage with better patient compliance. Different makes of pens are especially suited for older adults, adolescents, children and pregnant women. The insulin needles are smaller and results in lesser pain.

The Pump

An insulin pump consists of a small tank of insulin about the size of a cellphone worn outside the body such as on your abdomen, back, leg or arm. A tiny catheter inserted under the skin is connected to a tube joined to this reservoir of insulin. The insulin pump is programmed by a wireless device.

Pumps deliver insulin in three ways namely: through basal rate, bolus and correction. It supplies small increments of rapid- or short-acting insulin to the body over a 24 hour period and is termed the basal rate. This replaces the need for a long-acting insulin shot that has to be administered twice daily and roughly accounts for 50 percent of a your daily insulin requirement. The boluses are insulin injections administered by the pump for the carbs you eat at meal times while the correction is to adjust the pre-meal insulin bolus for glucose values outside of your blood glucose target range. The basal rates comes as low as 0.025 units per hour and the bolus rates of 0.1 unit doses.

The advantage of the pump is it improves blood glucose control by calculating individualized basal rates. It affords you convenience so that your mealtimes shouldn’t be rigidly scheduled. It also gives you the freedom to choose what to eat.

Additionally, the pump delivers a special meal bolus in the event of delays in absorption of some foods. Thus, large swings of blood glucose levels are avoided and lesser frequency of hypoglycemia even at night.

On the down side, a pump can malfunction.it can deliver too little or too much insulin. Since the pump only utilizes rapid-acting insulin, if the pump fails or too little is pumped out you might be at risk for ketoacidosis.

It sounds good to use a pump but it is expensive. With the additional cost of insulin pump supplies replacement and other diabetic supplies most diabetics can’t afford it.

As with the needle and the pen, you’d still have to test your blood sugar levels and have a bolus before meals and check your blood sugar levels before meals and at bedtime.

Your Choice

Choosing the best for you depends on many factors such as convenience and comfort; acceptability and knowledge on the mechanics of its use; how controlled your blood sugar level is; support and guidance from your health care provider; and costs and your lifestyle.

Some would opt to use the needle while some would sing praises to the pump and some would stick to their pens.

Insulin Resistance and Effects on Health

According to many medical experts the epidemics we are experiencing with obesity, diabetes, cardiovascular disease and cancer have not occurred without reason. There are two very little talked about reasons that some researchers have found are contributing to a huge part of these health challenges.

Insulin resistance or Syndrome X

Excessive toxins in our food and drink in the form of excitotoxins (another topic later)

Most people have no clue what these two problems are – or the extent of the health damage we are reaping as a result of them!

Here is the TRUTH: If we are ever going to get control of our health we MUST understand these two problems!

Why? Because they can both be avoided and once they are – many of our health issues will resolve!

Here are some of the symptoms of insulin resistance. See if you recognize any of them.

Fatigue. This is one of the most common symptoms, for some the fatigue follows a large carbohydrate meal – others are exhausted all day.

Brain fogginess. Sometimes the fatigue is physical but other times it is mental. The inability to focus is most evident, but poor memory, loss of creativity, and even some learning disabilities can occur as a result of insulin resistance.

Low blood sugar. Some low blood sugar is normal throughout the day, especially if meals are not eaten on a regular schedule. However, prolonged hypoglycemia with the above symptoms is not normal. Feeling agitated, jittery or moody that is quickly remedied with eating is also indicative.

Intestinal bloating. Most gas comes from excessive high sugar carbs. Insulin resistant people have gas – lots of it.

Sleepiness. Especially after a 20-30% carbohydrate meal.

Increased weight and fat storage…especially in the abdominal area.

Increased triglycerides.

Increased blood pressure.

Depression

If any of these sound familiar to you, perhaps you should investigate this information further.

First what is insulin resistance and how is it relevant to our health?

Insulin resistance is a condition where the cells of the body become resistant to the effects of insulin, that is – the normal response to the given the amount of insulin is reduced. As a result, higher levels of insulin are needed in order for insulin to have its effects. The resistance is seen with the bodies own insulin and if insulin is given through injection.

So why would our cells become resistant to something they were designed to accept? To put it very simply the pancreas has been overworked secreting insulin in an attempt to keep the high levels of glucose or sugar out of the blood because of the high glycemic (sugar) content of the food and drink many of us are consuming. You see – that is insulins job – to push blood sugar into our cells as it comes from the digestive system to be used for energy when we need it.

What we as individuals need to learn is – what kind of things that we are eating are causing this excessive amount of insulin to be released. We are told my some experts to eat high carbohydrate/low fat diets to be healthy and this is some of the worst advise we could listen to. What most people apparently do not understand is that there are “good” carbohydrates and “bad” carbohydrates – at least as related to our insulin levels.

Scientists have even come up with something called the glycemic index (GI) to help us recognize which are “good “carbs and which are “bad”. They have established a numerical system of measuring how much of a rise in circulating blood sugar a carbohydrate triggers – the higher the number, the greater the blood sugar response. There are charts you can find on the internet that list the glycemic index of foods.

The goal we should all be striving for is to keep the GI number in the medium to low level because less insulin will be needed for these foods.

A glycemic index of 70 or more is high

56-69 is medium

55 or less is low

There are many reasons that we should adhere to a lower glycemic diet.

The health problems that will be averted is the biggest reason! Again, the key is to eat low glycemic because it will mean low insulin. It is the high insulin that is causing us the problems. Here is a list of some of them:

obesity
Type 2 diabetes
high blood pressure
high cholesterol
osteoporosis
arthritis
heart disease
certain cancers – notably breast and colon

How many of you knew that it was high insulin in your blood stream that was keeping you fat and contributing to the host of other problems I listed? Don’t feel bad, neither did I until a few years ago, and neither do most other people today.

That is the problem. How can we fix something if we don’t know what’s broke? We are breaking our pancreas by eating too much high glycemic food….but there is more!

The low fat garbage you are told to adhere to is just that…GARBAGE! Has anyone else noticed that since we have all the “no fat” or “low fat” stuff on the grocery shelves we are fatter than ever!

There is a very good physiologic explanation for this and further more there are many scientists who know it too!

The body’s mechanisms for utilizing nutrients from food is complex and impossible for me to explain to you thoroughly (because I don’t understand all of it myself) but I can share a few basic principles with you to shed some light on this insulin thing.

Insulin is secreted by the beta cells in the pancreas.
Insulins purpose is to push nutrients into the cell that are being carried around in our blood stream.
Glucose or sugar is one of those nutrients that comes from carbohydrates and is very closely monitored in the bloodstream by the body because it is needed for energy to accomplish ALL bodily activity. In fact it is the brains only food.
Glucose is toxic to the body and can cause a multitude of problems if it remains too high in the blood stream.
Extra glucose or sugar is stored as glycogen in the liver and muscle cells but in a limited amount.

Once the glycogen stores are full all extra glucose or sugar is stored in fat cells as saturated fat.
If we consume high levels of sugar (from carbohydrates) it will require high levels of insulin to move it out of the blood.

When we repeatedly have high levels of sugar requiring high levels of insulin – two things begin to happen.

1. The pancreas gets tired and starts slowing down production of insulin.
2. The cell membrane gets tired of letting all the insulin in and starts becoming resistant.(It should be noted that this process happens normally as we age but is greatly accelerated with high glycemic foods.)

When either or both of these things happen to a big enough degree – we have a new diabetic born.

The problem with the no fat/low fat diets is misguided because fat has no effect on insulin. In fact, the right kinds of fat play an indirect role on helping lower the insulin response to carbohydrates.

According to Barry Sears, PhD and author of A Week In the Zone, fat slows down the entry rate of carbohydrates into the bloodstream, thereby decreasing the production of insulin. Fat also sends a hormonal signal to the brain that says to “stop eating” and the fewer calories you eat – the less insulin you need. And finally fat makes food taste better! So by taking fat out of the diet (which has no effect on insulin) and replacing it with carbohydrates (which have a strong stimulatory effect on insulin), you are virtually guaranteeing that you will become fatter!

Please Note: We do need to make sure that the fat we add back to the diet is mono unsaturated fat, found in such foods as olive oil, avocados, almonds, macadamia nuts and long-chain omega -3 fats found in fish and fish oils.

This seems too easy to fix! There are tons of good low and medium glycemic foods that we can fill our bellies with- especially if it means we won’t be as susceptible to all those chronic diseases and we can keep insulin resistance at bay!

Reference: A Week in the Zone by Barry Sears, pHD

The Effects of Inhalable Insulin

Since the 1920s, diabetics have had to go through the hassle of daily insulin injections. During that time, German researchers tried to discover more accessible and safer methods for diabetics to get their insulin needs and focused on an inhalable form of insulin. Their ideas eventually lead to the core concept of Exubera by Pfizer.

Pfizer Incorporated, based in New York (NYSE: PFE), is one of the largest pharmaceutical companies in the world. It produces the number-one selling drug Lipitor (atorvastatin, used to lower blood cholesterol); the oral antifungal medication Diflucan (fluconazole), the long-acting antibiotic Zithromax (azithromycin), the well-known erectile dysfunction drug Viagra (sildenafil citrate), and the anti inflammatory Celebrex (celecoxib) (also known as Celebra in some countries outside USA and Canada, mainly in South America).

Delivering Insulin by Inhalation Exubera is a type of inhalable insulin. It is administered through an inhaler, which sprays a form of human insulin into the lungs. Exubera works on similar principles as to how oxygen is absorbed. Oxygen flows into the lungs with a deep breath, makes contact with circulating blood, blood absorbs the oxygen, and is administered throughout the body. Exubera too is absorbed into the blood and regulates the amount of sugar within your blood. The inhaler is about the size of your hand when it is compacted, and about one foot long when it is being used. Some folks refer to it as a “bong”.

The drug Exubera is a powdered insulin that is sprayed into the lungs. This insulin is derived in the lab by using recombinant DNA technology. This method involves the use of laboratory ‘factory cells’. Scientists expose these cells to specific chemical signals that result in the mass production of insulin. Scientists produce in the insulin in this way because it is difficult to synthesize consistently and in high quantities. The insulin they recover from these cells is the basis for what is sprayed into your lungs. This is a very innovative method for producing biological substances in mass quantities.

Exubera works by going into the blood and regulating glucose levels. In a normal pancreas, insulin is produced when blood sugar levels get too high in the blood. In other words, insulin is used to regulate high levels of blood sugar and low levels of blood sugar. Those who would benefit from Exubera are those with type 1 diabetes because of their daily need for insulin. Exubera is different from other forms of insulin intake because it is taken through an inhaler instead of an injection. Human insulin, derived from recombinant DNA technology, is put inside an inhaler. Then, a blister surrounds the insulin, acting like a medicine capsule to safely deliver the insulin into the body. Some of the insulin is absorbed and degraded inside the lung and some of it is absorbed into the blood.

Exubera’s Safety Concerns

Exubera may sound like the end to needles for Type 1 diabetes patients who have to administer insulin intravenously. However, there are many issues and ongoing concerns with this drug. The first and foremost concern with the drug is the controversial approval by the FDA. Exubera is the first protein sprayed into the lungs that has been approved by the FDA. There has been much criticism of the FDA since 2004, and Exubera only adds to the list. Approval by the FDA was questioned by critics because of inconclusive clinical trials. For example, the effect of Exubera on those who have been smoking for the past 6 months is very serious. Lungs of smokers have the tendency to absorb more insulin, thereby decreasing blood sugar at a higher rate. Therefore, smokers run a higher risk of hypoglycemia. Absorption rates are increased anywhere from 2 to 5 times higher of non-smokers.

Many users, after the FDA had already given their approval, have reported trouble breathing after inhalation. There has been recent scientific discussion on decreasing lung capacity and damaging lung tissue. Although the FDA has approved of Exubera, there are still clinical trials testing for the long term effects on lung tissue. Exubera has been known to be especially dangerous with those with underlying lung disease. It is difficult to characterize those with stable or unstable lung disease. Because Exubera is so heavily dependent on healthy lung function, and the difficulty to characterize the stability of one’s lungs, Exubera runs the risk of overdosing many patients.

The National Institute of Health in the United Kingdom did not approve of Exubera. Their opinion on the matter was that Exubera “should not be recommended because it could not be proven to be more clinically or cost effective than existing treatments.” Their reaction reflected that the use of Exubera did not better control blood sugar more accurately or consistently or at a more competitive price. In fact, the National Institute for Health and Clinical Excellence Exubera estimated Exubera to be about $60 a year more than insulin injections. The Institute for Safe Medication Practices has also shown concern about its prescription to users. The dosage of Exubera is not consistent with the units of traditional insulin injections. For example, Exubera is usually described in mg (milligrams) while insulin is described in units. This leaves room for error. Also, there is a non-linear relationship between mg and units of insulin. For example, 1mg is equivalent to 3 units of injected insulin. However, 3mg is not equivalent to 9 units of injected insulin. This non-corresponding relationship only increases the danger of dosage. This is a real danger because Exubera is oftentimes prescribed in addition to insulin injections.

FDA Fast Stamp of Approval

Critics believe the accuracy is nowhere close to the FDA’s normal standards. The implications caused by lung disease, especially ones that are undetectable, create a risk for all users. This inaccuracy could have serious health risks. The only positive aspect of Exubera is that it is needle-free and may be less of a hassle during social situations. However, I do not think this is much of a positive aspect because if one were to use this inhaler in public, one should do it in a safe area such as a restroom. There are not many more locations you can use Exubera in that you can’t also administer insulin intravenously. Also, the fact that it is more expensive puts Exubera in a worse position than before. Using Exubera requires routine trips to the doctor to ensure healthy lung function. These trips are not always covered by insurance companies, resulting in hidden fees and higher cost to the user. HMOs will likely not approve the costs of the Exubera treatments which are double the cost of insulin injections. Side effects for drugs are always an issue. The FDA generally decides if the health benefits outweigh the cost of side effects. Administering insulin with an injection has little side effects if the user is trained. Exubera, at the cost of compromising lung capacity and lung tissue damage, merely eliminates the user error.

At this point, it is remarkable how Exubera has been approved by the FDA. Upon closer inspection, there have been some controversial techniques of marketing the drug to the public. Dr. Edward Ryan, a Canadian Endocrinologist, commented on the convenience and efficiency of the drug, claiming that Exubera is “obviously an advantage…I would say the majority like it.” Although this may appear wholesome, the Canadian Diabetes Association has found his research to be funded by Pfizer, the manufacturer and producer of Exubera.

The FDA has been under heavy criticism in the past few years. After knowingly allowing the drug Vioxx to stay in the market for four years, despite its proof of serious side effects, the FDA has come under careful scrutiny. The approval of Exubera has lead to ever closer investigations. Of the nine voting board members, three have been found to have consulted with or spoken with Pfizer. Which is more surprising is that the panel chairman has stock with Pfizer as well.

Should you use Exubera?

If you are considering Exubera, the best decision you can make is an informed one and of course talk to your doctor. Be aware that the side effects are much more serious than other FDA approved drugs and may be a large price to pay just to avoid insulin injections. Exubera is an alternate delivery method of insulin, nothing more. Remember, the FDA approval is not an indication of safety. It is an indication of research; be sure to know all of its effects on your body. Pfizer has pulled Exubera from the market, there are other similar products in the pipeline from competitors. Although inhalable insulin has been associated convenience with some diabetics, it should also be associated with consumer caution.