Introduction to Artificial Pancreas Treatment (APT)

Transcription

1 Introduction to Artificial Pancreas Treatment (APT) Artificial Pancreas Treatment using the Bionica Artificial Pancreas System is the only US FDA cleared safe and effective way to stop the progression of diabetes and in most ways reverse the chronic complications of diabetes. It is uniformly effective for both Type 1 and Type 2 diabetic patients. APT has been shown to be effective in even the most impaired patients. It has been steadily developing with confirming published clinical trials (See Publications and reports). Correcting the Core Problem: Diabetes is not a disease of improper blood sugars, they are just a symptom. Diabetes is a disease of improper metabolism according to every medical writing, yet treatments have focused on blood sugar. The Artificial Pancreas Treatment is the only treatment which addresses this core problem, and does so by mimicking the natural way that a pancreas signals a liver to cause proper metabolism. Diabetes is technically caused by a lack of carbohydrate processing enzymes made by the liver. This is the result of insufficient stimulation of the liver by the pancreas. Fortunately, when the body metabolizes carbohydrates it stops converting high levels of lipids and free fatty acids, which directly cause all of the complications of diabetes through improper levels of inflammatory cytokines (IL-6, IL-2, TNFα, NF which exist when a patient cannot process carbohydrates properly (a person with diabetes). The first important role of insulin is to signal the liver to produce the enzymes that are necessary for proper carbohydrate metabolism. These are the pathways necessary to induce the Krebs (citric acid cycle) metabolism. APT uniquely addresses and restores proper enzymes, which is treating the core problem. Mimicking the natural stimulation of a pancreas using a sophisticated two-signal delivery process, APT effectively makes proper metabolism a reality for people who, other than with this treatment, cannot ever achieve anything near to normal metabolism. With proper carbohydrate metabolism, two things occur. First, normal levels of cellular energy are restored (a diabetic person has approximately 70% of the intra-cellular energy of a nondiabetic person). And secondly, the destructive high lipid metabolism with elevated free fatty acids are reduced. Because lipid metabolism is the back-up system of providing nutrients to the cells, it was never meant to be the primary source of energy, as it is with the diseases of diabetes (both type 1 and type 2). The reason both types of diabetes have the same complications and disease outcomes is simple, they both fail to provide proper resting carbohydrate metabolism, and that leads to elevated lipid and free fatty acids, reactive oxidative species, inflammatory responses (especially with the endothelium) ischemia, reproduction errors (transcription), remarkably less intra-cellular energy (ATP) and a host of other inflammatory cytokine related body wide dysfunction. Artificial Pancreas Treatment Page 1

2 There are many published clinical trial studies which demonstrate that it is simply a very diverse number of factors from improper metabolism which cause all the complications of diabetes. They include kidney failure, blindness, amputations, heart disease, stroke, neuropathy, progressing wounds, fatigue, sexual dysfunction, diabetes dementia and depression, just to name the more obvious. There are other disease states which have, at their core, improper metabolism, such as Alzheimer s Disease and age dementia, dementia from Parkinson s, fatty liver disease, and autoimmune diseases causing improper metabolism. The complexity of hormone metabolism has caused many to look at chemically induced changes for an answer, when in fact a resolution of the core problem was always available through replicating proper organ stimulation. Krebs received the Nobel Prize for just understanding a small part of metabolism, and the function of the endocrine system is so monstrously complicated that it has baffled science but the Artificial Pancreas Treatment is strikingly obvious, it mimics the pancreas to provide a bi-signal to the liver using insulin and carbohydrates, and by doing so, achieves what compounds have never been able to accomplish, normal ATP and a reduction of lipid metabolism. Noticing the difference between normal and diabetic insulin response to a simple glucose load, which causes a monstrous first phase release of insulin, caused Ford Gilbert to design an additive wave using many small bursts, which unexpectedly, and very surprisingly turned out to be the way man was designed. This exposed the reality that one need only achieve proper liver stimulation to stop the complications of diabetes, and provide individual cells the energy necessary to perform the function defined by their DNA. No other treatment achieves these outcomes, no other technology mimics the normal pancreas signals to the liver, and no other technology is even close to doing so. Certainly chemical actions on an organ which is incapable of reproducing what it was originally doing is better than nothing, but still allows the complications and is grossly inferior to the Artificial Pancreas Treatment. The Treatment History: Artificial Pancreas System and Artificial Pancreas Treatment are based on many clinical trials and human treatments, using several names including PIVIT, Metabolic Treatment, CIIIT, etc. They are all part of the evolution of APT, and all were developed using the Bionica infusion device, a US FDA, and CE (European) cleared medical infusion device (pump) with special abilities and software. APT achieves normalized carbohydrate processing by providing the two (2) signals needed for the liver to perform its job of producing the enzymes which are deficient in diabetic people and keep their whole bodies from properly metabolizing carbohydrates of all kinds. The patient s improvement in body-wide metabolism is documented by standard metabolism measurement equipment. Both Types of Diabetes: Since Artificial Pancreas Treatment using the Artificial Pancreas System addresses the core problem of diabetes, it is effective for both Type 1 and Type 2 diabetes. It was first used in 1984 with Type 1 patients, where the progression of the disease was significantly slowed or stopped in the most severely ill. In 1992 studies of Type 2 patients began, Artificial Pancreas Treatment Page 2

3 and the same effectiveness has been proven for Type 2 diabetes. After an estimated 200,000 treatments, there is no doubt that the therapy works on both Type 1 and Type 2 patients. Developed in University Settings: APT was developed and then tested in a number of university and centers of excellence including Harvard (Joselin), University of California Davis, University of Arizona, Scripps, Temple University, and the Mayo Clinic, just to name a few (see publications). APT is main-stream medicine, seeking only to provide the body with proper stimulation, and thus allowing the body to achieve its own repair. All of the clinical trials addressing outcomes have used the generally accepted standard tests for assessing the patient s diabetic conditions. Safe, Effective and Necessary: Following the necessary years of clinical studies proving the effectiveness of APT, Medicare Administrative Law Judges and other judges have ruled that the treatment is no longer experimental, is not investigational, and is medically necessary for the patients treated. A landmark lawsuit against CalPers achieved the same result, as have cases against Blue Cross. While reimbursement is not uniform, it can be obtained from insurance through the dispute resolution systems. These decisions are provided in a separate document and contradict any claims by insurance that there is something left to be done or that the patients do not get well from APT. Long Development Cycles has Caused Delay: In chronic diseases, it takes many more years of studies to show that a treatment is effective, and then stays effective instead of losing effect or causing harm. Most drugs take approximately 20 to 30 years from discovery to approval. Artificial Pancreas Treatment has been in development for years because of these realities. Seemingly slow progress is actually relatively quick for this type of broad application and outcomes Development time was also increased due to the cost of setting up clinics and paying physicians for research. Finally, the task of making the treatment into a protocol which every practitioner with every co-morbidity could treat in multiple locations was a huge task which is now achieved. Treatment. Patients treat for 4-5 hours in the clinic once a week for a few weeks, then a most treat once every two to even three weeks. Patients understand the devastating physical and mental impact of diabetes, and 5 hours twice a month in exchange for getting their lives back is a small price to pay. Patients enjoy coming to the clinic because of their new quality of life, new energy, new hope and the stopping of complications, the Second Bite of the Apple. Many times family members realize and reports all the benefits of treatment as the diabetic person often does not know how their mental acuity has been compromised by not processing carbohydrates. This is because the primary food of the brain, nerves and eyes is carbohydrates. During a treatment day, three infusions are given with the patient sitting in a recliner or chair but still able to walk around etc. During the treatments, carbohydrates and intravenous insulin are administered using the Bionica programmed infusion device. The patient stays in the treatment area, and continues to read, watch TV, type, compute, telephone or engage in any other passive activity. Clinics normally have an open area without dividers at the request of patients. Many Artificial Pancreas Treatment Page 3

4 patients enjoy coming into the clinic early in the morning, and being finished by shortly after lunch time. Dramatic Outcomes: APT is not a subtle treatment of marginal improvement. It is effective even for the severely ill. The more ill the patient, the more dramatic the outcomes. This is extremely gratifying for diabetes practitioners who have, in the past, only been able to watch the disease progress. Objective of APT Treatment: The treatment works by returning patients to a more normal resting metabolism, thereby addressing the core problem of diabetes. Once cells have the ATP (energy) to achieve repair, the DNA of the cells know what to do, and do it. No physician who has worked with APT during the clinical trials has reported any negative outcomes. They uniformly understand the logic of providing the natural stimulation needed to metabolize properly. Treatment Outcomes: The treatment is independently clinically proven safe and effective for the major complications of diabetes including kidney disease, cardiovascular disease, wound healing, retinopathy, hypertension, neuropathy, and the general maladies of diabetes including lack of wellbeing, energy, sleep, sexual functions and the likes. With deficient metabolism it is not surprising that widespread basic biochemical abnormalities exist. The fundamental body-wide defect is the reduced ability of glucose to be used as a fuel for body tissues, and a corresponding increase in lipid use. Diabetic people fail to metabolize (burn) the carbohydrates (sugars or glucose) and instead metabolize lipids (fats) and free fatty acids at a much higher rate than normal, ( butter burners ). Unlike conventional treatment where the patient is starved of appropriate carbohydrates, patients on the Artificial Pancreas Treatment metabolize carbohydrates and can eat more normal and healthy foods as their bodies can burn carbohydrates. When the core problem is addressed, it is reasonable that widespread and diverse outcomes would occur, and they do! All of the long-term studies have shown a significant improvement and stopping, retarding and then reversing all major complications of diabetes. No study has been a failure. Because the therapy works at a body-wide cellular level restoring metabolic integrity and energy production in all cells, the DNA undertake repair and the treatment causes reversal, in cardiomyopathy, nephropathy, retinopathy, neuropathy, erectile dysfunction, wound healing and dementia. One uniform benefit is the greatly improved sense of well-being and energy. Feeling normal and physically well is unique to ATP. Most people with diabetes have forgotten what it feels like to feel well as they have slowly deteriorated over time. With APT they often say that they just did not realize how sickly they had become until they felt normal again. Another benefit of the treatment is the elimination of diabetic loss of consciousness due to low blood sugar, called hypoglycemic coma. Not only is low blood sugar a condition which can cause a diabetic to have traffic and other accidents, it is a condition which has been shown to cause brain impact. With blood glucose of only 53 mg/dl (normal is 80 to 120), neurological symptoms appear. Conventionally treated diabetics regularly fall below this number. Hypoglycemic reactions are Artificial Pancreas Treatment Page 4

5 more common to diabetics trying to achieve tight control of their blood sugars, and of course are common to those diabetics who are brittle. Hypoglycemia is recognized and avoided by APT treated patients. Another surprising benefit of APT is that it reduces hypertension (high blood pressure) in patients. Hypertension is linked to several complications. The randomized cross-over studies with APT have clearly demonstrated highly significant improvement in blood pressure in 3 months without any other changes. High blood pressure is associated with heart disease and kidney loss, always resulting in early death. Fatty Liver Disease: The power of reestablishing the Krebs Cycle includes remedial stimulation of the liver. With or without diabetes, fatty liver disease is reversed, and normal liver enzyme levels can be achieved after treatment of 3 to 6 months. Safe and Effective: Both the treatment and the unique Bionica infusion pump have flawless safety records, with no adverse reactions, no claims, no recalls, malpractice suits or anything negative stemming from the treatment. Every person with diabetes complications will benefit from the APT treatment. APT is fully developed, rolled out in a turn key manner, and is ready to treat millions of critically ill people. No further research or development is needed. Operations: The cost of setting up a clinic with all equipment including the APS is relatively inexpensive, and the returns are very attractive. This is because: 1. There are no special requirements for the facilities, and both installing and moving the equipment is easily achieved. 2. The clinics are scalable, and a clinic can start with 6 to 8 chairs and grow to any size without any loss of economies of scale. 3. The market is huge, just for the severely ill patients. And there is an ever increasing number of new patients each day. 4. Each clinic chair can be used for two shifts, and thus one chair can treat two people each day. This means that the demand for each chair is intense. 5. The reimbursement rates are very attractive. Medicare publishes the rates that are used for APT, and insurance companies typically pay significantly more than the Medicare rate. Even at Medicare rates, the business is highly profitable. A rough cost of business per day per patient is $200 per day depending upon personnel and facilities. 6. Mid-level medical personnel deliver the treatment. The treatment is best given by med techs who are overseen by a nurse practitioner or physician's assistant. There is no need for the physician to be there when the treatment is being given. The physician can consult the patients for other things while making a good wage just on initial and daily interviews. 7. Payment is Electronic. Medicare and insurance companies now require electronic submissions. They use the same AMA codes for diagnosis and treatment. APT uses standard codes and will not seek a bundled code for the treatment itself. Artificial Pancreas Treatment Page 5

6 8. Advertisement costs will only be significant at the beginning. Each clinic will advertise its opening until there are sufficient patients to fill the clinic. After that, wordof-mouth appears to be effective, and the advertising expenses will reduce. 9. No other or competing technologies. There are no other technologies that normalize carbohydrate metabolism or address the core problem of diabetes. Stem cells do not do this, and no other technologies imitate how man was made to have the body heal itself. 10. Insurance costs are extremely low. Because the therapy has a proven perfect safety record, there are no additional requirements for use of medical personnel or a clinic. The clinic itself does not provide treatment under a license, and thus is not liable for medical malpractice. Individual nurse practitioners and physician assistants have inexpensive insurance policies. In addition bionic a, the manufacturer has product liability insurance which is also low because of the lack of any claims to date. 11. Home therapy will also provide benefits. After the patient has normalized his or her metabolism, they different and stable. After 4 months, the treatment regimen usually becomes predictable, and the same doses are used over and over. This allows the patient and one other significant person to be trained for home therapy which will be needed as there are too many people with diabetes to treat them in clinics after they are stable. Home patients come to the clinic and take the pump home. Conclusion: The result of all the prior work is that the Artificial Pancreas Treatment is one of the most important medical advancements of this decade. All that is needed is funding for clinics where medical professionals will help many needful people and be properly paid for delivering Artificial Pancreas System treatments. Other Indications: The anecdotal outcomes on concurrent conditions such as Alzheimer s Disease, Parkinson s Disease, Fatty Liver Disease (above), low energy, and diseases of degeneration suggest that the frontier of metabolic normalization has just now been reached. The benefit is that there may be no additional regulatory approval, or approval may be immediate for these wellness conditions. You can find more information at or (916) Artificial Pancreas Treatment Page 6