San
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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