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 Advances in Diabetes

Implantable insulin pumps | Insulin inhalers | Insulin Pill | New insulins | Pain Free Glucose Tests | Continuous Monitoring Device | Islet Cell Transplant | Gene Therapy | Diabetes Prevention Trial-Type 1 | The SHOW Trial-Type 2 | Vaccine

Twenty years ago when a person was diagnosed with diabetes, it meant early death often preceded by loss of limbs, blindness and kidney failure. These days are over. There have many new advances in knowledge, medication and in technology that have made it possible for people with diabetes to live long, productive lives. New developments are happening all of the time:

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.

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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.

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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.

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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.

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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.

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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.

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