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Artificial Pancrease Treatment Frequently Asked Questions

A) Why do they call it "Artificial Pancreas" Treatment®?

Because in the treatment our special-designed and programmed pump is mimicking the pancreas of a healthy person when they eat carbohydrates (e.g. sugar) - sending pulses of insulin to the liver. These pulses trigger the liver to produce at least 33 different enzymes which are necessary for the cells in the body to metabolize carbohydrates.

When these cells metabolize carbohydrates they produce adenosine triphosphate (ATP) which is the chemical energy a cell requires to perform its function in the body.

For most people with diabetes (both type 1 or type 2) their liver is not properly receiving the oscillations of insulin from the pancreas and therefore is not producing and secreting the enzymes required for proper metabolism. The core problem of diabetes is improper cellular metabolism – high blood sugar is a symptom of this core problem.

Using a standard insulin pump that many people with diabetes use today, even if it is programmed to deliver insulin in pulses, will not achieve the results described above. This is because with these pumps the insulin is delivered under the skin and by the time the insulin is received by the liver any pulse is sufficiently blunted that the required insulin concentration and oscillation threshold is not achieved. Many of the required metabolic enzymes are therefore not produced.

With the APT therapy the pulses are delivered intravenously and within 4 seconds the liver will experience the appropriate oscillations and threshold. Thus, the liver will be activated to produce and excrete the required metabolic enzymes. The cells throughout the body will be fed and begin to function properly.

B) What is Artificial Pancreas Treatment® (APT)?

APT is a treatment using FDA-cleared medical devices including a specially-designed and programmed pump that sends pulses of insulin intravenously as the patient drinks a glucose solution. The patient breaths periodically into a respiratory/metabolic measurement system (developed for sports medicine and cardiology departments) that monitors resting carbohydrate metabolism improvement. Adjustments in the pump concentration and dosing are made to assure that the body is properly metabolizing the maximum amount of glucose (carbohydrate). This treatment works toward all of the cells in the body getting the critical food that they need to function properly.

APT is the only known therapy that stops, retards and in most cases reverses all of the complications of diabetes - both type 1 and type 2.

Over $40 million dollars has been spent over 25 years developing the therapy and associated equipment and confirming the effectiveness of the treatment by a series of clinical trials. Over 2,000 patients have been treated with over 100,000 accumulated treatments. There have been 13 peer review articles in well-known medical journals and more studies and articles to be published.

C) How do you know the cells are properly metabolizing carbohydrates?

In the clinic we use a metabolic measurement system that was originally designed for sports medicine and cardiology departments. This machine (on a wheeled cart fitted with separate tubes for multiple patients) measures the volume of carbon dioxide breathed out (expired) while the patient is at rest, and is used to monitor the treatment and provide information for dosing.• When a person with diabetes is first measured before starting the treatment their carbon dioxide output is low relative to a healthy person. This is because they are not metabolizing carbohydrates.

When they finish sessions of Artificial Pancreas Treatment® the carbon dioxide expiration numbers will be almost three times higher indicating that they are achieving complete carbohydrate metabolism. The higher the carbon dioxide numbers the better the cells are metabolizing sugar and the more cellular energy is being created in the cells.

D) Why is it so important to metabolize carbohydrates?

When the cells are able to metabolize carbohydrates the mitochondria in the cells are able to create at least ten times more ATP (adenosine triphosphate) than they do when the cells are metabolizing lipids (fat). ATP is the main energy source for the majority of cellular functions so when the cells have more ATP they are able to begin to perform the functions that they were designed for. Also, when the cells are metabolizing carbohydrates, they do not need the extra oxygen that fat metabolism requires, and this need for extra oxygen is counter-productive.

When the cells are not able to metabolize carbohydrates (even though the glucose is in the blood and tissue right next to the cells) they are often unable to effectively perform their functions and thus, depending on genetic predisposition and which cells are more susceptible, the associated complications of diabetes result (nerve, kidney, heart, vision, blood pressure, etc.)

E) How long does the treatment last?

Typically in a clinic visit the patient receives three-one hour sessions with a break between sessions. The typical time of the break is 40 - 60 minutes. At the end of the last session the patient rests for 10-15 minutes before leaving the clinic to be sure all blood sugar levels are stabilized. Therefore the total time in the clinic will be 4 - 6 hours, depending on the patient.

F) What does it do for these complications of diabetes?

1) Neuropathy
The nerve cells are highly dependent on glucose metabolism. Without glucose metabolism nerve cells starve and eventually will die. When patients with neuropathy begin the APT therapy the nerves throughout the body are immediately fed and begin to respond in a surprising but normal way.

We have a rule of thumb that if you were able to feel your feet within the past five years you will feel your feet again. For some fortunate patients they will begin to feel their extremities again before the end of the first session. Others will see results in a number of weeks.

Our clinical trials showed that all patients improved their neurological functions on APT, with an amazing 65% improvement in nerve conduction velocities.

Patients experiencing the pain and tingling of neuropathy should expect this pain to be reduced or go away completely.

Patients with sexual dysfunction (both male and female) can expect to regain that function and for males, ED will be reversed if the patient was able to achieve an erection within the last 5 to 10 years.

A combination of being able to feel your feet, experiencing increased blood flow and improved health of the tissues will reduce the chance of blisters developing again and heal those that are already in place. This means preventing amputations.

2) Wounds
One of the remarkable things about APT is how well patients’ wounds heal, even if these wounds have not closed for many years. Diabetes is the number-one cause of amputations in the US. These amputations should be avoided for any patients on APT therapy as most all of the wounds are expected to heal. Future wounds are expected to be avoided as the skin gets healthier with increased blood flow and there is returned feeling to the extremities which causes an awareness when a blister is developing.

3) Kidney Disease
Patients with chronic kidney disease (CKD) experience a loss of creatinine clearance (CrCl) of 8-10 “points” per year (units are mL/min) even when they are tightly controlling their blood sugar. With APT this filtration related number has been proven to improve dramatically. This means that patients with 1/3 of their kidney function (CrCl > 30 - 40) should never progress to dialysis, and those with higher function will actually increase their filtration levels. Also protein in the urine will be reduced. Patients with CrCl > 50 - 60 have seen their kidneys actually improve their functioning level.

This means that individuals with diabetes in CKD Stage 3 and 4 should never advance to Stage 5 (End Stage Renal Disease) and dialysis. And those in Stage 3A will most likely begin to improve their kidney function.

4) Retinopathy
The cells in the eyes are particularly sensitive to glucose metabolism. Most patients who were experiencing vision problems due to their diabetes report improved vision after just a few APT sessions. This includes color recognition and brightness.

Patients with diabetic retinopathy can expect to avoid further laser treatment. Depending on the severity of their current condition they should expect improving eye health and significant vision improvement.

5) Heart Disease
The heart muscle responds very well to the APT therapy and increased carbohydrate metabolism. The heart especially enjoys carbohydrate metabolism because there is no need for the extra oxygen required for lipid and free fatty acid metabolism. That is why diabetes heart disease (cardiomyopathy) is a huge problem which does not respond well to tight glucose control. (In fact, tight glucose control worsens diabetic heart disease and has been reported to cause more frequent heart attacks). APT patients with low ejection fractions can expect to improve dramatically and return to significantly higher ejection fractions and higher energy levels. This reduces the chances of congestive heart failure which is the cause of many of the diabetic deaths.

6) Other Conditions
Hypoglycemic Episodes - should be reduced by 98%. Hypoglycemic awareness is also restored.

Hypertension – clinical trials have shown a dramatic improvement in hypertension in just 90 days. Amounts of medications to maintain acceptable blood pressure levels will be reduced or eliminated

Erectile Dysfunction - patients have uniformly reported consistent reversal if they were able to have an erection within the past 5-10 years. There are additional benefits in sexual pleasure reported by APT patients (both men and women) as feeling and increased blood flow returns to all of the extremities.

Chronic Fatigue and Muscle Fatigue - both are effectively treated by the therapy. Patients will see dramatic energy level improvement, particularly where energy levels have become a problem.

Gastrointestinal Problems - when these problems are caused by diabetes patients have seen relief as a result of APT therapy. Gastro paresis is a form of neuropathy so patients have seen rapid relief from this complication of the disease.

G) How long do I go between treatments?

When the patient first starts the treatment we recommend two treatments on two consecutive days in order to more quickly reawaken the liver to produce the enzymes needed for proper metabolism and to be able to maintain better storage of glycogen. Then the patient will typically return from 1 to 4 times a month, based on the body’s ability to maintain its carbon dioxide output levels. This is an indication of the liver’s ability to “maintain its charge” between sessions.• After a period of time (this varies from patient to patient) when the complications have stopped to an acceptable level then the patient can stop treatments. He/she will then work closely with their doctor and our staff to monitor whether it is necessary to periodically come back for maintenance sessions.

H) What special instructions are there before starting the APT therapy?
The day before your treatment continue your normal routines and non-diabetes-related medications except the evening before stay off of any fatty foods. If blood sugar is greater than 350 mg/dL before bed take one half the normal amount of long-acting insulin. If less than 350 mg/dL do not take long-acting insulin.

The day of the treatment do not take your diabetic medications that morning. Do not take any insulin unless your sugar level is over 400 mg/dL, and then only one-half of what you would normally take for that level. You can take your blood-pressure medications but as time goes on, (during the first 90 days) blood pressure medications will need to be reduced, usually by more than one-half and often can be discontinued completely. The day of the therapy you should have a small high-carbohydrate breakfast and no fat (butter/bacon/etc.).

After the therapy is over you should go to your next meal, monitoring the blood sugar according to the discharge instructions you will be provided, and engage in light exercise such as a walk, after the meal to reenergize your body.

I) How should I expect to feel?

1) During the Therapy
During the therapy you should expect to feel normal with an increased feeling of well-being. In some cases it may take several sessions for this feeling of well-being.

Patients often feel a resurgence of blood flow throughout the body where it has been lacking before.

Sometimes patients experience diarrhea due to drinking so much glucose solution which soon goes away.

Some patients sleep during the treatment, some remain even more active than normal, it depends upon how ill the patient is before beginning treatments.

2) Right after the Therapy
Because the body may also be producing its own insulin some patients may feel hunger for carbohydrates, and if they do, they should take carbohydrates and check their blood sugar.

Most patients report a very sound night’s sleep as APT reestablishes the circadian rhythm of blood pressures (where both pressures go down at night).

3) After Several Weeks of Therapy
Patients will feel progressively better with each therapy session. They will very often begin to feel their feet if they haven’t been able for several years. Their eyesight will get clearer and colors will seem more vivid, if this was a problem. Their skin color will return due to improved metabolism. They will even see wounds beginning to heal and old scars improve.

Patients report a general sense of well-being after 3-5 treatments.

4) After Ongoing Therapy
Patients will continue to feel better with more energy in all areas of their body, have less daily fatigue, will usually regain any lost sexual function, and reduce their diabetes related depression. If they had any wounds these wounds will all be well on their way to healing or totally healed. Patients with neuropathy should be feeling their feet again and when there were problems, eyesight should be improving with no further laser treatments. Other expected improvements are listed in later sections below.

J) Do I continue to see my current doctor?

The Artificial Pancreas Treatment® does not cure diabetes, it only stops or retards the complications of diabetes from getting worse and, in most cases, reverses these complications. Individuals receiving the APT treatment should continue to see their current doctor and follow his/her recommendations between therapy sessions. When not at the clinic the patient should continue to take their medications including insulin if the patient was on insulin, and continue to control their blood sugar. Our experience is that the amount of medication required or the amount of insulin administered will be reduced the longer that the patient is on the APT therapy.

K) Does insurance cover this treatment?

Many of the large insurance carriers are providing coverage.

We are working with all insurance companies to expand their coverage of APT, and where resistance is encountered, the insurance company may be forced to pay.

Patients who are not covered by insurance are either using medical credit cards or making cash payments until they obtain insurance or go on to the home treatment.

Our goal is to help as many patients as possible to improve their health and we have developed several programs, including hardship rates to make this therapy available. We are willing to work on a patient-by-patient basis.

We have several medical credit card accounts that we can set up for you that allows for nominal monthly payments.

L) I would like to go to my doctor first what should I tell him?

The majority of doctors are not aware of this specific treatment because there is no way for them to deliver the APT therapy. In order to help you understand the treatment, be able to report to your doctor what is achieved, and better understand all of the medical benefits, you should visit our medical facility. You will receive an in-depth evaluation of your metabolism by our medical staff and can provide that to your doctor. We will also work directly with your doctor providing our clinical verifications and any other requested information. A visit and evaluation of your metabolism will enable you to describe in detail the treatment process to your medical advisor. The evaluation is free and non-intrusive (You merely blow into sports medicine equipment while at rest.) You will also have the opportunity while in the clinic to talk with our other patients and hear their remarkable stories of how the treatments have changed their lives.

M) How long do I continue treatments?

At a minimum you should continue the therapy until all of the serious complications of diabetes have stopped and, when possible, have reversed. At that point you may be able to reduce the frequency of your visits or stop for blocks of time until and unless the side-effects return.

Every patient's body responds a little differently and the time before the side-effects return will vary.

Ultimately, years from now, we can hope that there will be breakthroughs in finding a cure for diabetes or new more-effective medications. In the mean time the goal of the APT therapy is to maintain as healthy a body as possible until that time arrives.