Monday, April 9, 2007

Diabetes the latest treatments

Insulin

Implantable insulin pumps
Researchers are working hard to develop an implantable insulin pump that can measure blood sugar levels and deliver the exact amount of insulin needed. This would make it possible to mimic the action of natural insulin delivery.

Scientists are making progress with an implantable capsule that continuously produces insulin and releases it to the bloodstream. It contains insulin-secreting cells that borrow nutrients from the body to keep producing insulin indefinitely. The University of Illinois biomedical engineer developed the capsule with funding from the National Science Foundation. He presented his results at a recent meeting of the American Vacuum Society; they were also published in the November 2001 issue of Transactions in Biomedical Engineering.

The capsule's developers have also overcome biocompatibility problems, which have been an obstacle to other implantable devices. Using microchip technology, they have succeeded in creating a capsule that won't be attacked and destroyed by the body's immune system.

Testing for long-term usage and determining the ideal dosage level are the next steps in the product's development. It is several years away from being available for general use.



Insulin inhalers
Although daily injections of insulin would still be needed, inhaled insulin is currently in clinical trials and may be headed for a fast track approval by the Food and Drug Administration (FDA). These inhalers are about the size of a flashlight and uses rapid-acting insulin. The sprayed insulin is inhaled into the mouth and coats the mouth, throat and tongue. The insulin passes quickly into the bloodstream.

Insulin Pill
The discovery of a new polymer that may allow development of an effective insulin pill was reported at a recent meeting of the American Chemical Society. When the polymer is used as a pill coating, it allows insulin to get into the bloodstream without being destroyed by the digestive system. So far it has only been tested in animals. Some experts question whether insulin in pill form will prove useful, since dosing is so critical and often variable.

New Insulins
In the past year, three new formulations of insulin have become available which have been designed to offer the advantages of simpler regimens and better glucose control for people whose diabetes must be treated with insulin. All are human insulin analogs derived from recombinant DNA technology. They are:

Glargine (from Aventis Co.) is a basal insulin, offering a more continuous activity with much less of a peak than NPH insulin. It can be used with a very-rapid-acting insulin such as lispro or aspart, and should provide a flatter basal amount of insulin. Until now this has only been possible with twice daily injections of ultralente or by the basal rate of an insulin pump. This approach tries to permit more normal mealtime patterns individualized to a person's own habits.
Aspart (from Novo Nordisk) is a very-rapid-acting insulin that can be injected 15 minutes prior to eating. Its fast action also allows more freedom in the timing of meals and the amount of food eaten.
A 75/25 lispro mixture is the first of the analog mixtures available (from Eli Lilly); it contains Lilly's very-rapid-acting lispro and a novel human insulin analog called NPL. It is designed for those who need better control after meals and want to use an insulin pen.


Monitoring

Pain Free Glucose Tests
The Food and Drug Administration has approved Amira Medical's new AtLast Blood Glucose System and it's now available for consumer use. The system allows patients to monitor their blood sugar without the pain of sticking their fingers to get blood samples.

The system is the first to contain both a lancing device and a blood glucose meter all in one. It uses a unique disposable test strip to obtain blood samples from the forearm, thigh or upper arm, areas that have fewer nerve endings so it doesn't hurt as much as a finger stick.

Continuous Monitoring Device
The Food and Drug Administration has approved a wristwatch-like device that provides more information for managing diabetes. It is intended for use along with, not as a replacement for, fingerstick blood tests to monitor glucose, in order to ensure accurate results.

The GlucoWatch Biographer extracts fluid through the skin by sending out tiny electric currents. The watch may be worn for 12 consecutive hours, producing 3 measurements every hour, even while asleep. An alarm will sound if blood glucose levels are detected to be dangerously low, or if a measurement was skipped, as can occur in the presence of excessive sweat.

The device is available only by prescription to detect trends and track patterns in glucose levels in adults age 18 and older. It is manufactured by Cygnus, Inc.



New Treatment

Islet Cell Transplant
A new islet cell transplant technique has shown promise in people with Type 1 Diabetes. Called the 'Edmonton' technique, the transplants have resulted in seven patients becoming insulin free for up to 14 months after treatment. Clinical trials are now underway at 10 national diabetes centers to see if the insulin reversal can be successful with more patients. The Edmonton technique uses islet cells (cells from the pancreas) from two or more donor pancreases. The cells are transplanted into a person with diabetes and then special medications are given to prevent rejection of the new cells. One difficulty with the transplants is that even though a person may become free of the need to take insulin, the medications to prevent rejection of new tissue must be taken for a lifetime. These medications have side effects.

Gene Therapy
Two recent reports describe research into gene therapy for different aspects of diabetes. These reports are in the forefront of what will no doubt be ongoing and exciting research arising from the decoding of the human genome.

Scientists have identified a gene called SHIP2 that appears to regulate insulin. Such findings make SHIP2 a potential gene therapy target for the treatment of type 2 diabetes aimed at improving the individual’s insulin regulation.
A protein that blocks the overgrowth of blood vessels in the eye is being studied as possible gene therapy for diabetic retinopathy. A recent study showed that treatment with the protein, called pigment epithelium-derived factor, or PEDF, prevented excessive new blood vessel formation in an animal model of retinopathy. It may also be used to treat macular degeneration.

As scientists identify specific genes whose absence or improper functioning are associated with specific conditions, more possibilities for gene therapy are offered – for diabetes as well as all disease.



Vaccine

"Vaccine" against Diabetes on the Horizon
Scientists have developed the world's first drug that stops the destruction of pancreatic beta cells in humans. It thereby offers the possibility of preventing type 1 diabetes in people at high risk and of halting its progress in people newly diagnosed with it.

Israeli scientists have worked on this agent for more than a decade. To date, 200 patients in Israel, England, Hungary, Bulgaria and Germany have been successfully treated. Results published in a recent issue of The Lancet showed that three injections of the compound given within six months of diagnosis of type 1 diabetes successfully arrested the progression of the disease in newly diagnosed patients. After treatment, these patients produced insulin and required fewer insulin injections. They did not experience any harmful or major side effects. While this data looks promising, additional studies are under way to confirm its effectiveness and safety.

The drug is a peptide, a type of protein. By modifying a fragment of the protein, the developers created a drug that can selectively block the activity of immune cells that attack the pancreas. It thus deactivates the cells that attack the pancreas without interfering with the rest of the body’s immune system.

The company that will manufacture the vaccine, Peptor Ltd., expects to apply to the FDA for approval in 2004.



Clinical Research

Diabetes Prevention Trial - Type 1
The U.S. government is funding a nationwide study to see if Type 1 Diabetes can be prevented or delayed. Nine medical centers and more than 35 clinics in the United States and Canada are taking part. The study is operating on knowledge from smaller studies that have shown that diabetes can be delayed by injecting regular, small doses of insulin or taking oral insulin.
Participants will be enrolled in one of two studies based on their degree of risk for developing diabetes over the next five years:


Insulin Injection Trial - People with a greater than 50 percent chance of getting diabetes will inject low doses of insulin twice daily. Once a year they will go to a DPT-1 center to be admitted to admitted to a hospital for four days of insulin therapy.


Oral Insulin Trial - People with a 25 percent to 50 percent chance of developing diabetes will take an insulin capsule every day. (If you can't take a capsule you'll be given insulin crystals to dissolve in juice).
In each study, participants will be assigned at random to either receive treatment or a placebo in which no insulin will be given. If you participate, you will be closely monitored for diabetes.
You are eligible to participate in the trial, called the DPT-1, if you are at risk for developing diabetes. For more information about participating in this study, call 1-800-425-8361.

The SHOW Trial - Type 2
SHOW stands for Study of Health Oucomes of Weight Loss. It's a clinical trial at 15 centers in the United States that will try to determine if weight loss in obese people with Type 2 Diabetes improves health. People who are obese have a Body Mass Index of 30.0 or greater.
The study will involve 6,000 obese patients with Type 2 Diabetes for a period of four to seven years. Recruitment for the study will begin in 2001.

Diabetes

Diabetes is a life-long disease marked by high levels of sugar in the blood.

Causes, incidence, and risk factors Diabetes can be caused by too little insulin (a hormone produced by the pancreas to control blood sugar), resistance to insulin, or both.
To understand diabetes, it is important to first understand the normal process of food metabolism. Several things happen when food is digested:
A sugar called glucose enters the bloodstream. Glucose is a source of fuel for the body. An organ called the pancreas makes insulin. The role of insulin is to move glucose from the bloodstream into muscle, fat, and liver cells, where it can be used as fuel. People with diabetes have high blood sugar. This is because their pancreas does not make enough insulin or their muscle, fat, and liver cells do not respond to insulin normally, or both.
There are three major types of diabetes:
Type 1 diabetes is usually diagnosed in childhood. The body makes little or no insulin, and daily injections of insulin are needed to sustain life. Type 2 diabetes is far more common than type 1 and makes up most of all cases of diabetes. It usually occurs in adulthood. The pancreas does not make enough insulin to keep blood glucose levels normal, often because the body does not respond well to the insulin. Many people with type 2 diabetes do not know they have it, although it is a serious condition. Type 2 diabetes is becoming more common due to the growing number of older Americans, increasing obesity, and failure to exercise. Gestational diabetes is high blood glucose that develops at any time during pregnancy in a woman who does not have diabetes. Diabetes affects more than 20 million Americans. About 54 million Americans have prediabetes. There are many risk factors for diabetes, including:
A parent, brother, or sister with diabetes Obesity Age greater than 45 years Some ethnic groups (particularly African Americans, Native Americans, Asians, Pacific Islanders, and Hispanic Americans) Gestational diabetes or delivering a baby weighing more than 9 pounds High blood pressure High blood levels of triglycerides (a type of fat molecule) High blood cholesterol level Not getting enough exercise The American Diabetes Association recommends that all adults over age 45 be screened for diabetes at least every 3 years. A person at high risk should be screened more often.

Symptoms High blood levels of glucose can cause several problems, including frequent urination, excessive thirst, hunger, fatigue, weight loss, and blurry vision. However, because type 2 diabetes develops slowly, some people with high blood sugar experience no symptoms at all.
Symptoms of type 1 diabetes:
Increased thirst Increased urination Weight loss in spite of increased appetite Fatigue Nausea Vomiting Patients with type 1 diabetes usually develop symptoms over a short period of time, and the condition is often diagnosed in an emergency setting.
Symptoms of type 2 diabetes:
Increased thirst Increased urination Increased appetite Fatigue Blurred vision Slow-healing infections Impotence in men Signs and tests A urine analysis may be used to look for glucose and ketones from the breakdown of fat. However, a urine test alone does not diagnose diabetes. The following blood glucose tests are used to diagnose diabetes:
Fasting blood glucose level -- diabetes is diagnosed if higher than 126 mg/dL on two occasions. Levels between 100 and 126 mg/dl are referred to as impaired fasting glucose or pre-diabetes. These levels are considered to be risk factors for type 2 diabetes and its complications. Random (non-fasting) blood glucose level -- diabetes is suspected if higher than 200 mg/dL and accompanied by the classic symptoms of increased thirst, urination, and fatigue. (This test must be confirmed with a fasting blood glucose test.) Oral glucose tolerance test -- diabetes is diagnosed if glucose level is higher than 200 mg/dL after 2 hours (This test is used more for type 2 diabetes.) You should also ask your doctor how often to you need your hemoglobin A1c (HbA1c) level checked. The HbA1c is a measure of average blood glucose during the previous 2 to 3 months. It is a very helpful way to determine how well treatment is working.
Ketone testing is another test that is used in type 1 diabetes. Ketones are produced by the breakdown of fat and muscle, and they are harmful at high levels. The ketone test is done using a urine sample. High levels of blood ketones may result in a serious condition called ketoacidosis . Ketone testing is usually done at the following times:
When the blood sugar is higher than 240 mg/dL During acute illness (for example, pneumonia, heart attack, or stroke) When nausea or vomiting occur During pregnancy Treatment There is no cure for diabetes. Treatment involves medicines, diet, and exercise to control blood sugar and prevent symptoms and complications.
LEARN THESE SKILLS Basic diabetes management skills will help prevent the need for emergency care. These skills include:
How to recognize and treat low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia) What to eat and when How to take insulin or oral medication How to test and record blood glucose How to test urine for ketones (type 1 diabetes only) How to adjust insulin or food intake when changing exercise and eating habits How to handle sick days Where to buy diabetes supplies and how to store them After you learn the basics of diabetes care, learn how the disease can cause long-term health problems and the best ways to prevent these problems. People with diabetes need to review and update their knowledge, because new research and improved ways to treat diabetes are constantly being developed.
SELF-TESTING If you have diabetes, your doctor may tell you to regularly check your blood sugar levels at home. There are a number of devices available, and they use only a drop of blood. Self-monitoring tells you how well diet, medication, and exercise are working together to control your diabetes and can help your doctor prevent complications.
The American Diabetes Association recommends that premeal blood sugar levels fall in the range of 80 to 120 mg/dL and bedtime blood levels fall in the range of 100 to 140 mg/dL. Your doctor may adjust this depending on your circumstances.
WHAT TO EAT You should work closely with your health care provider to learn how much fat, protein, and carbohydrates you need in your diet. A registered dietician can be very helpful in planning dietary needs.
People with type 1 diabetes should eat at about the same times each day and try to be consistent with the types of food they choose. This helps to prevent blood sugars from becoming extremely high or low.
Persons with type 2 diabetes should follow a well-balanced and low-fat diet.
HOW TO TAKE MEDICATION Medications to treat diabetes include insulin and glucose-lowering pills called oral hypoglycemic drugs.
Persons with type 1 diabetes cannot make their own insulin, so daily insulin injections are needed. Insulin does not come in pill form. Injections that are generally needed one to four times per day. Some people use an insulin pump, which is worn at all times and delivers a steady flow of insulin throughout the day. Other people may use a new type of inhaled insulin.
Insulin preparations differ in how quickly they start to work and how long they remain active. Sometimes different types of insulin are mixed together in a single injection. The types of insulin to use, the doses needed, and the number of daily injections are chosen by a health care professional trained to provide diabetes care.
People who need insulin are taught to give themselves injections by their health care providers or diabetes educators.
Unlike type 1 diabetes, type 2 diabetes may respond to treatment with exercise, diet, and medicines taken by mouth. There are several types of medicines used to lower blood glucose in type 2 diabetes. They fall into one of three groups:
Medications that increase insulin production by the pancreas. They include glimepiride, glipizide, glyburide, repaglinide, nateglinide, and sitaglyptin. Medications that increase sensitivity to insulin. These include metformin, rosiglitazone, and pioglitazone. Medications that delay absorption of glucose from the gut. These include acarbose and miglitol. There are some injectable medicines used to lower blood sugar. They include exenatide and pramlintide.
Most persons with type 2 diabetes will need more than one medication for good blood sugar control within 3 years of starting their first medication. Different groups of medications may be combined or used with insulin.
Some people with type 2 diabetes find they no longer need medication if they lose weight and increase activity, because when their ideal weight is reached, their own insulin and a careful diet can control their blood glucose levels.
It is unknown if hypoglycemic medicines taken by mouth are safe for use in pregnancy. Women who have type 2 diabetes and take these medications may be switched to insulin during pregnancy and while breastfeeding.
Gestational diabetes is treated with insulin and changes in diet.
EXERCISE Regular exercise is especially important for people with diabetes. It helps with blood sugar control, weight loss, and high blood pressure. People with diabetes who exercise are less likely to experience a heart attack or stroke than diabetics who do not exercise regularly. You should be evaluated by your physician before starting an exercise program.
Here are some exercise considerations:
Choose an enjoyable physical activity that is appropriate for your current fitness level. Exercise every day, and at the same time of day, if possible. Monitor blood glucose levels before and after exercise. Carry food that contains a fast-acting carbohydrate in case you become hypoglycemic during or after exercise. Carry a diabetes identification card and a mobile phone or change for a payphone in case of emergency. Drink extra fluids that do not contain sugar before, during, and after exercise. Changes in exercise intensity or duration may need changes in diet or medication dose to keep blood sugar levels from going too high or low.
FOOT CARE People with diabetes are prone to foot problems because of the likelihood of damage to blood vessels and nerves and a decreased ability to fight infection. Problems with blood flow and damage to nerves may cause an injury to the foot to go unnoticed until infection develops. Death of skin and other tissue can occur.
If left untreated, the affected foot may need to be amputated. Diabetes is the most common condition leading to amputations.
To prevent injury to the feet, people with diabetes should adopt a daily routine of checking and caring for the feet as follows:
Check your feet every day, and report sores or changes and signs of infection. Wash your feet every day with lukewarm water and mild soap, and dry them thoroughly. Soften dry skin with lotion or petroleum jelly. Protect feet with comfortable, well-fitting shoes. Exercise daily to promote good circulation. See a podiatrist for foot problems or to have corns or calluses removed. Remove shoes and socks during a visit to your health care provider and remind him or her to examine your feet. Stop smoking, which hinders blood flow to the feet. Support Groups For additional information, see diabetes resources .

Expectations (prognosis) With good blood glucose and blood pressure control, many of the complications of diabetes can be prevented.
Studies have shown that strict control of blood sugar and blood pressure levels in persons with diabetes helps reduce the risk of kidney disease, eye disease, nervous system disease, heart attack, and stroke.

Complications Emergency complications include diabetic hyperglycemic hyperosmolar coma .
Long-term complications include:
Diabetic retinopathy Diabetic nephropathy Diabetic neuropathy Peripheral vascular disease Hyperlipidemia , hypertension , atherosclerosis , and coronary artery disease Calling your health care provider Go to the emergency room or call the local emergency number (such as 911) if symptoms of ketoacidosis occur:
Increased thirst and urination Nausea Deep and rapid breathing Abdominal pain Sweet-smelling breath Loss of consciousness Go to the emergency room or call the local emergency number if symptoms of extremely low blood sugar (hypoglycemic coma or severe insulin reaction) occur:
Weakness Drowsiness Headache Confusion Dizziness Double vision Lack of coordination Convulsions or unconsciousness