A new diabetes screening machine.

Diabetes is a life-altering disease that has affected seven percent of all Americans -- and that number is only projected to increase. Complications of the disease include blindness, kidney disease, nervous system disease, dental disease and problems during pregnancy. It's also the sixth leading cause of premature death for persons who have the disease compared to persons of similar age.

Patients with type 1 diabetes -- also known as juvenile diabetes --are usually first diagnosed in childhood or young adulthood. These patients rely on insulin injections to control their blood glucose levels and to keep them alive because their pancreas no longer makes insulin. Patients with Type 2 diabetes -- also know as adult-onset diabetes -- have the most common form of diabetes.

It usually begins with insulin resistance, where fat, muscle and liver cells do not use insulin properly. Over time, the pancreas loses the ability to produce enough insulin in response to meals. Risk factors of Type 2 diabetes include being overweight and inactive.

The traditional way of testing to see whether someone has diabetes is to draw them into a "fasting" state by having them consume a syrupy, sweet liquid, then drawing blood to test blood glucose levels. This can be time consuming and painful for some patients. Some believe the uncomfortable testing method keeps some patients from coming in to get tested. As a result, their disease continues to progress, making their condition even worse as complications develop before the diagnosis is eventually made.

The VeraLight Scout system tests for diabetes in a fast, painless way. Using non-invasive fluorescent light, the machine shines the reflective light onto the patient's skin to measure AGEs (advanced glycation endproducts), which are well-known markers of diabetes, in the connective tissue of a patient's forearm. Patients place their arm in the machine, the light shines, and minutes later, doctors have a diagnosis.

Users say one of the benefits of the test is that it can very sensitively detect small changes in the connective tissue that may reflect early onset diabetes. As a result, they can detect diabetes early on. Secondly, the device could predict the development of diabetes complications in patients with established diabetes.

The system has been tested on thousands of individuals in tests across the country. The device itself weighs about 10 pounds. Introduction into the United States' market is slated for the second half of 2008.

Robert Ratner, M.D., vice-president of scientific affairs at MedStar Research Institute, talks about the Scout diabetes screening system, a new machine that makes testing for diabetes easier.

Is it true that diabetes is the most undiagnosed disease?

Ratner: Currently, we have an epidemic of obesity in both the United States and throughout the world. Along with that epidemic of obesity comes an epidemic of diabetes. Unfortunately, most diabetes is diagnosed anywhere from seven to 10 years after its onset and with that patients are developing complications as their presenting sign of the disease.

What is diabetes?

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	Diabetes testing Many people with diabetes don't learn that they have it until it's too late.

Ratner: Diabetes is an abnormality of metabolism in which the body is unable to store and utilize fuel appropriately. It's the most common metabolic disease in the world, currently affecting well over 250 million people worldwide and approximately 20 million people in the United States.

What causes diabetes and why is it usually undiagnosed?

Ratner: Diabetes is a silent disease. Not until the development of complications when blood sugar is very high, do patients get symptoms of the disease. So on average, individuals don't know they have the disease for seven to 10 years after the actual onset.

Does that mean by the time they know they have diabetes, it's pretty severe?

Ratner: Frequently, as often as 20 to 25 percent of the time, individuals actually have the complications of diabetes at the time they're diagnosed -- whether it's retinal disease, eye problems or presenting with heart attacks and strokes. So it's important for us to identify the disorder as early as possible in order to intervene and try to prevent those complications.

Is diabetes always caused by obesity?

Ratner: Probably not the direction you want to take, but it usually is. The most common form is.

Do you find that people are afraid to get tested for diabetes because they're worried about the diagnosis or also because the test does not sound comfortable?

Ratner: The problem with getting the diagnosis of diabetes is that it takes time. You have to go to a specialized area and you have to prepare for it. Either a fasting blood glucose test is done on blood or, in fact, a glucose tolerance test, which requires three days of preparation -- coming in for at least two hours, usually three hours of waiting time in a doctor's office or a laboratory. Then you have to send the blood off for a definitive diagnosis. So it's the time, the complexity, the cost that really diminishes our ability to identify the disease.

How exciting is it for you to have a test that gets rid of all those challenges?

Ratner: To be able to diagnose diabetes whenever an individual is present, whether it's in a doctor's office, a pharmacy, even a fire station -- to put their arm down onto a little machine and within five minutes get an answer without the need for sterile technique, potential blood contamination, or the need for certified lab -- offers the promise of identifying individuals with early diabetes throughout the world in a very easy manner.

It sounds revolutionary. Why is this diabetes test so much simpler than the traditional test?

Ratner: Traditionally, diabetes has been identified by identifying high glucose levels in the blood. We now know that those high glucose levels have consequences in a whole variety of tissues, and actually cause many of the complications of diabetes. By looking at the connective tissue in the forearm, we are able to identify those biochemical changes without the need of sticking a patient or drawing blood or sending samples off to a certified laboratory.

How does the machine work?

Ratner: What the Scout machine actually does is shine a light into the skin -- into the deeper areas beneath the skin -- and measure the reflectance -- how much light bounces back in very specific wave lengths. Those wavelengths correlate with the amount of glucose that has been attaching to the connective tissue underneath the skin. By measuring that and correlating it with glucose levels in the blood, we are able to identify thresholds, which may reflect either new onset diabetes or may reflect the risk of complications in those individuals with established diabetes.

If you have diabetes or if you don't have diabetes, what does the machine show?

Ratner: What we're looking at now are two issues related to glucose in the tissue. One is can we identify very small amounts of these changes in the connective tissue that may reflect new onset diabetes. So, if the glucose levels have been somewhat elevated, we can very sensitively identify diabetes early on. Second, we're looking at those individuals who have established diabetes and asking the question, 'Do these levels of changes in the connective tissue actually predict the development of diabetes complications?'

So you're looking to see if you can diagnosis patients early, but also looking at patients that currently have diabetes?

Ratner: That's exactly right -- the early recognition of disease so we can begin to intervene and give physicians some idea which patients are at greater risk for the development of diabetes complications, so more attention can be given to them.

Tell me about the study: How many patients have taken part in it and how long have you been doing it?

Ratner: We've been working with the company that has developed Scout for about three and a half years. We've done three studies with the Scout machine in a variety of different settings. The first study incorporated 100 subjects here in the Washington D.C. area and another 100 subjects in Albuquerque. Based on the findings of that study, which were very, very promising, we proceeded to a much larger study with over a thousand patients nationwide and about 200 of them coming from the Washington area. We are now embarking on a third study looking at approximately 250 patients here in Washington who have established diabetes to see if we can correlate the rate of complications with the Scout measure.

What has been the success rate of Scout?

Ratner: In terms of identifying early diabetes, we believe the Scout measurement is as accurate, if not more so, than the fasting glucose level in the blood. The definitive study for diabetes is a two-hour glucose tolerance test, which is cumbersome -- not particularly pleasant for patients -- and isn't used routinely in doctor's offices.

Does that test involve drinking the mixture?

Ratner: Exactly right. So you come in, you have blood drawn, you drink a very sweet solution and then you have to wait for two hours before having additional blood drawn. Because that is such a cumbersome test, it's not used as often as it probably ought to be. So we're looking for alternative means of identifying the disease.

How hopeful are you about this machine?

Ratner: We're very optimistic that using this type of technology will provide us with an alternative means of identifying diabetes -- staging diabetes -- so that we can be more aggressive in our interventions.

And, as you mentioned earlier, your hope is that this machine will be made more available to the public?

Ratner: With the epidemic of diabetes ongoing both in the U.S. and worldwide, it's imperative that we have simple convenient ways of identifying people with diabetes. To be able to place machines in nontraditional environments -- whether they are pharmacies or grocery stores in the United States, or in third world nations having them in churches, civic centers or town halls -- may be the mechanism by which we can better identify individuals with disease.

When do you anticipate something like that happening?

Ratner: We're probably a year to two years away from having definitive data that would allow us to accurately predict the development of diabetes. At that point in time, we would hope that registration and approval throughout the world would allow implementation of this technology.

Do you know the success rate of Scout compared to the traditional test?

Ratner: That is actually getting into statistics. It becomes very, very difficult to explain. The definitive way of identifying individuals with diabetes is with a two-hour, 75 gram glucose tolerance test. We did that in all of our subjects who were screened; but in addition, we looked at the Scout measure and we looked at the fasting glucose -- the simple blood test done after an overnight fast. What we've done in all of our studies is to use the glucose tolerance test as the definitive diagnostic tool for type 2 diabetes. We then compared the Scout measure and the overnight fasting glucose and found the Scout measure was as good, if not better, than the overnight fasting glucose in identifying those individuals who had abnormal glucose tolerance.

So the Scout allows you to diagnose diabetes earlier?

Ratner: Our studies have suggested that the Scout system not only identifies those individuals with previously unrecognized diabetes, but actually identifies individuals with pre-diabetes in whom intervention can be provided to prevent the ultimate onset of disease.

Is there anything you would like to add?

Ratner: The beauty of this test is that it doesn't involve any needle sticks -- the skin is never violated -- there are no side effects of it and it's quick. You can do it anytime of the day or night. It doesn't matter if you've eaten. It doesn't matter if you've been sick. So it can be done at a convenient time for the individual as opposed to a convenient time for the medical system.

Does Scout allow you to test more people for diabetes than you normally would be able to?

Ratner: Absolutely. The ability and the ultimate cost of testing for diabetes should be significantly reduced as a result of these newer, noninvasive technologies. When you think about applying diabetes diagnosis out in rural communities or in third world environments, in which diabetes is rising very, very quickly, you don't have to have the sterile syringes. You don't have to have the tubes. You don't have to process blood. You don't have to have a laboratory in order to make a diagnosis of diabetes. Rather, it's simply putting the arm down on the machine, waiting the two to three minutes and having your results.

Has the device been approved by the FDA?

Ratner: This is not yet FDA approved. The ongoing studies are designed to satisfy regulatory approval.