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No More Needles for Diabetics

By Sean Henahan, Access Excellence

insulin inhalerSan Diego, CA (6/22/99)- Ask people with diabetes what the worst part of having the disease is and chances are they will say it is the need for daily injections of insulin, along with daily needlesticks to measure blood sugar. New methods for delivering insulin and monitoring blood sugar may grant the wish to be needle free, according to new research presented at the 59th Scientific Sessions of the American Diabetes Association.

left- A new aerosol form of insulin

People with Type I diabetes, also know as insulin dependent diabetes, typically inject insulin at least three times per day to maintain a safe level of blood sugar. This insulin replaces the natural insulin that would normally be produced by islet cells in the pancreas. Because it is a protein, and would be digested in the stomach, researchers have been stymied in their efforts to develop alternatives to injection for insulin delivery.

A collaborative effort among researchers from major pharmaceutical companies has produced a form of insulin that can be inhaled through an aerosol device similar to that used by people with asthma. The insulin comes in a powdered form and is delivered directly to the lungs, bypassing the digestive tract. The insulin inhaler is now in the final stages of clinical trials in the US. Results of the these clinical studies indicate that the new delivery system is as safe and effective as insulin administered by subcutaneous injection. Moreover, a survey of patients participating in a clinical trial revealed that those using inhaled insulin were significantly more satisfied with the convenience and ease of use of the inhaled form compared with those taking insulin by injection.

A California company has developed another inhalable insulin in an aqueous formulation, called AERx. A randomized clinical study of that product also indicated that the new delivery system was as safe and effective at controlling blood sugar as subcutaneous insulin.

Type I diabetes accounts for no more than ten percent of all cases. Patients with the more common Type 2, or non-insulin dependent diabetes may also require insulin treatment when not controlled by other medications. A clinical study suggests inhaled insulin may also be a viable option for these patient. Not only did the inhaler provide more convenient delivery of insulin, it also produced improvement in glycated hemoglobin levels, the gold standard of gluocse control. These improvements were not seen in patients taking only standard medications..

Oral formulations of insulin are also making their way towards clinical trials. A safety study of a new oral form of 'hexylin' insulin showed that the compound was absorbed successfully, with predictable effects on blood glucose levels. The insulin is encased in a polymer, which protects it from degradation in the gastrointestinal tract, and facilitates its absorption into the blood stream through the gut wall.

Pain Free Monitoring

Large clinical trials have confirmed that better control of daily glucose swings by people with diabetes translates into fewer long term complications such as kidney disease and heart disease. Unfortunately, this requires frequent needle prick testing throughout the day. Relief may be at hand. A number of glucose monitoring products now approaching FDA approval offer the promise of bloodless testing. One new system successfully uses near infrared scanning to monitor clinically relevant hypoglycemia via the thumbs of normal and Type I diabetic patients. Another system, the "Gluco Watch" allows users to check glucose levels at 20-minute intervals throughout the day via painless reverse iontophoresis from interstitial fluids.

"This new technology enables users to check their glucose levels at about 20-minute intervals throughout the day - without doing anything once they put it on and without feeling anything other than a tingling sensation," reported Satish K. Garg, MD, director of the adult diabetes program at the University of Colorado Health Science Center in Denver, in a recent interview "Checking glucose levels is an important part of diabetes self-management, and anything that makes it easier to do is likely to increase patient compliance with the physician's recommendations and improve diabetes control," he explained.

Diabetes affects more than 142 million people around the world. Five to ten percent of these cases are Type I diabetes, also called insulin-dependent diabetes mellitus (IDDM), or more recently, immune-mediated diabetes. According to the American Diabetes Association the combined direct and indirect cost of the disease approach $98 billion in the U.S. alone.

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