Not too long ago, I had the pleasure of speaking with David Kliff, of Diabetic Investor. When diabetes came knocking on David's door - he took the higher road, literally, and many would agree he has made the most of it.

David created Diabetic Investor to share his opinion as a leading authority on the business of diabetes from the unique perspective of a diabetic. Along the way he has gained interest in leading-edge technologies and breakthrough medicines to enhance the treatment of diabetes. His research and his craft for controlling his diabetes has significantly impacted his health for the best - and it keeps getting better.

David is now a marathon runner. His training efforts have resulted in a resounding 45 pound weight loss, cutting his insulin dose substantially, and improving his overall health. He launched a blog to promote his participation in the New York City Marathon this November. Checkout Dave's Run for Diabetes, and show your support for his efforts to go the distance for diabetes - all 26.2 miles!

Oramed is developing a soft gel insulin capsule for the treatment of diabetes. The company has recently announced it the successful completion of its clinical trial demonstrating the safety and efficacy of the oral insulin gel capsule.

The pills were shown to reduce blood sugar, with no significant adverse effects. The insulin used in the gel caps is a generic brand of human insulin. The duration of the insulin is similar to Regular. But the most beautiful thing about these gel caps is that they reintroduce the liver into glucose metabolism, thereby reducing the likelihood of dangerous lows associated with injected insulin and oral medications. This could blow away the necessity of blood sugar testing because you are regulating glucose metabolism in the liver, like a person without diabetes.

Up until now, the idea of insulin pills or tablets was inconceivable due to the fact that insulin, when swallowed, breaks down in the digestive system. Oramed's patented technology overcame the problem of digestion as well as permeability to the intestine. The company's goal is for the completion of formal Phase 1 studies in the US by mid-2008. Sign me up!

Imagine taking insulin was as easy as applying skin cream. Guess what - it's not so far fetched an idea, thanks to Phosphagenics and it may be coming soon!

Phosphagenics' has patented a transdermal carrier technology (TPM) that rapidly transports insulin across the skin without disrupting or damaging its surface. The company has recently announced successful results from clinical trials in Australia. This confirmes the TPM technology is safe and effective at delivering insulin into the bloodstream, without adverse events. The trial showed that the insulin safely penetrated through the human skin and delivered insulin into the bloodstream over a sustained period of time. Could this be the next generation of basal insulin? Adios Lantus. Arrivederci Levemir! Almost -- TPM/Insulin, applied topically, delivered insulin through the skin and into the bloodstream for up to 8 hours. So like sunblock -- you'll probably have to reapply.

Weep not, fellow Americans. Although Phosphagenics is based in Australia, they are in the process of applying for Phase 2 clinical trials in the U.S. Big ups to the Muffin Man for keeping me abreast of his leading-edge news from the diabetes-friendly forefront!

Eli Lilly has an award they give to people who have been diabetic for 25, 50 and 75 years. They call it the Lilly for Life Award. The award recognizes people who have been enslaved to the exorbitant expenses of diabetes management, in addition to the other schedules of daily life. Endearing isn't it? The award is a significant token of Lilly's appreciation for all you have endured and sacrificed.

Lilly awards people who have used insulin for 25 years with the monetary equivalent of what your diabetes management has cost. All your copays for each bottle of insulin, each box of syringes, each blood sugar testing strip, and your ability to adapt to the ever-changing technology of diabetes care (I swear, it says that in block letters) - Lilly awards you $42,500!! I told you I lived in the land of milk and honey. ACTUALLY - it's a medal and a consent form to have your face exploited in Big Pharma marketing. You should've bought the stock! The shareholders of LLY paid approximately $1.75 per share 25 years ago, when you were diagnosed. Today that share is worth approximately $56. Anybody know the math on that return? It's probably around 3,000%.

Let's go back to that statement ever-changing technology of diabetes care. Why must it be ever-changing? Doesn't that sound a lot like never-ending? We need not spend too much time on identifying how to treat this disease when we've got that down. What we need to do is spend more time and energy on preventing the disease from happening in the first place. That is what I consider achievement. Achieve that, Lilly! And by the way - I'll take 3,000% of my $42,500 while you're at it. Thanks.

For more the more than 300,000 users that once relied on animal-derived insulin, the final chapter of animal insulin is finally ending for the US market. In December 2007, Novo Nordisk has officially decided to discontinue making animal-insulin. Their explanation doesn't go into great detail why they chose to discontinue it. But the supporting evidence they use to warrant the decision is a little weak.

Novo says, animal insulin is derived from the pancreas of slaughtered animals. This statement is as true as the statement "human insulin is derived from the pancreas of slaughtered humans". Novo continues, since that time there has been significant improvement of insulin quality and formulation. Absolutely true! In fact, a Novo pork product was shown to be greater than 99% pure, while an Eli Lilly human insulin only exceeded the 97 percentile. As a consequence, demand for these old animal insulins has declined by as much 20% in the last year to a point where approximately 2% of all insulin users are currently using these products. Largely due to the fact doctor's were advising their patients they must prepare to switch to GM insulin because animal-derived insulin would be nearly impossible to obtain. True. The research that introduced GM insulin (back in the 80s) was preemptive, at best. The claims supporting it was better than the existing insulin choices was clearly debatable .A telling similarity to the discovery about Avandia.

The long-term results of GM insulin and its analogs would prove to be a nightmare if the right questions were asked, and the data properly collected. Is it fair for any of the companies to ask us to change from an insulin product we have grown to love? No, but much like the off-Broadway play suggests: We love you (as a customer). Your diabetes is perfect (for our bottom line). Now change your insulin (we don't feel like making that kind anymore). Too bad type 1 diabetics forced to change to GM insulin didn't have the outspoken advocates like those taking Avandia.

In the next 3 to 5 years, we will have a new generation of control upon us providing continuous glucose monitoring. Some of these marvelous technologies will not require a drop of blood, while others will embody the tried-and-true stick-to-itiveness we all know and loathe.

Please join me as we browse the isles of things to come (and things now available) for continuous glucose monitoring.

The DexCom STS Continuous Glucose Monitoring System is a glucose sensor that reports glucose values every 5 minutes for up to 72 hours. The sensor is inserted in the abdomen. After a 2 hour start-up period, the STS System is calibrated with 2 fingerstick measurements taken by a traditional glucose meter. Checkout Amy Tenderich's review on Diabetes Mine of the DexCom Continuous Glucose Monitoring Sytem.

MiniMed Medtronic has 3 different versions: the Gold, the Guardian RT, and the Paradigm Real-Time Continuous Monitor.

Menarini GlucoDay S is a device worn by the patient for the continuous monitoring of glucose in the subcutaneous interstitial fluid. Monitoring is performed via insertion in the abdominal region of a microfibre for dialysis having the diameter of a human hair. Inside the microfibre a solution transports the patient's glucose to a biosensor within the instrument.

M-Biotech Glucose Biosensor is a minimally invasive implantation for painless and convenient monitoring. The key feature of our efficient Glucose Biosensor is the combination of a glucose-sensitive hydrogel and a miniature pressure sensor. Glucose-responsive hydrogels are biocompatible materials that either swell or contract when the glucose concentrations change in the body fluid surrounding the hydrogel.

The PreciSense System includes a microcapsule placement unit and a light detecting non-invasive reader unit. The microcapsule placement unit poses the right dose of glucose-responding microcapsules in the upper layer of the skin, painlessly. The glucose assay components in the microcapsules generate a fluorescence signal that corresponds to the glucose level. The non-invasive reader unit monitors this glucose binding event through FRET, Fluorescence Resonance Energy Transfer, which is directly related to the concentration of glucose.

Sensors for Medicine and Science glucose sensor is implanted under the skin in a short outpatient procedure. The sensor automatically measures interstitial glucose every few minutes, without any user intervention. The sensor implant will communicate wirelessly with a small external reader.

Synthetic Blood Implanted Glucose Biosensor claims to offer significantly more accurate glucose readings in a range of 30-500 mg/dl. The implanted Glucose Biosensor continuously monitors blood glucose without the need for finger sticks. The most accurate glucose monitor available, the implanted biosensor can be programmed to monitor blood glucose according to a predetermined schedule, thus eliminating problems of patient compliance. The sensor alarms for dangerous, life threatening conditions such as hypoglycemia.

GlucoLight Corporation is developing a low-cost non-invasive blood glucose monitor for home use by diabetic patents. GlucoLight's unique optical approach, microScatterTM (microscatter) technology, is based on patented technologies in the area of Optical Coherence Tomography (OCT) and Low Coherence Interferometry (LCI). There is a working prototype with published clinical data on healthy volunteers.

The GlucoWatch G2 Biographer was approved to detect glucose level trends and track patterns in people with diabetes. It must be used along with conventional blood glucose monitoring of blood samples. The device, which looks like a wristwatch, pulls body fluid from the skin using small electric currents. It can provide six measurements per hour for 13 hours. (See David Mendosa's review).

Living Cell Technologies has been given the go ahead to conduct clinical trials of its DiabeCell diabetes product in New Zealand.

DiabeCell is a porcine islet cell product for the treatment of insulin- dependent diabetes. The pig cells are injected into the body without any immunosuppressant drugs. The cells produce insulin to help regulate blood glucose levels appropriate to the amount of glucose detected in the blood stream of the diabetic recipient.

The Medical Director of Living Cell Technologies explains that DiabeCell offers considerable advantages over other available treatments in addition to the fact there is no need for immuno-suppressive drugs. Anther problem of islet transplants is the strain on the supply of islets. This is not a problem with the DiabeCell because their supply of cells derive from natural biocertified pig herds, unlike human organ donors.

LCT's application is to conduct the clinical trial of its DiabeCell product on 8 long standing Type 1 diabetics. The clinical trial is expected to be approximately 12 months in duration. This will then be followed by a trial on a larger scale. The trial will be conducted at a New Zealand hospital and involves the simple injection of encapsulated islets into the abdomen of the diabetic patients. It is anticipated that the trial would start by the end of 2007.

A white elephant is a supposedly valuable possession whose upkeep exceeds its usefulness, and it is therefore a liability. Every type 2 diabetic is a valuable possession to someone: a mother, a father, a sister, a brother, a daughter, a son...you get the picture. But when it comes to the complications of the disease - it costs the U.S. health system an extra $22.9 billion a year to treat these complications.

"It is a pretty significant wake-up call for people, or should be. It really points out the importance of managing the disease," said Willard Manning, a health economist at the University of Chicago who worked on the report.

Dr. Daniel Einhorn says "the fact that people are still getting complications means we are not using our tools effectively enough," When people fail to follow their diet, exercise and drug treatment plans, the disease leads to complications that boost the total health bill to $57.1 billion. "Either the patient doesn't recognize they have it and complications develop, or they are not good about adhering to their doctor's orders," he said, adding, "We've got to do a better job of managing the disease." Dr. Einhorn serves on the board of the American Association of Clinical Endocrinologists.

Of course, it's the patient -- NOT the drugs they are using. It couldn't possibly be the drugs.

Much like a roadblock, but with a fortuitous outcome -- an experimental heart drug didn't achieve the primary goal of a late-stage trial but it did dramatically reduce the risk patients would develop diabetes.

The anti-oxidant, anti-inflammatory drug, the first of its kind, reduced the risk of developing diabetes by 64% and demonstrated a small but statistically significant reduction in blood sugar after 12 months. The study included data from 6,144-patients. The company believes this finding to be a serendipitous outcome, despite the initial shortcomings of the trial objective. They need to confirm it in a large clinical trial. The impressive diabetes results may come as a surprise to investors who have abandoned AtheroGenics or who have been betting the drug will fail.

Heart patients in the study received either 300 milligrams of the drug or a placebo on top of a host of standard-of-care medicines they were already taking, such as aspirin, cholesterol-lowering statins, blood thinners and/or diabetes medicines.

The drug had an undesirable impact on blood fats, raising bad LDL cholesterol by about 12% and lowering good HDL cholesterol by roughly the same amount. There were also some potentially troubling safety signals with a trend toward more heart failure in those taking the drug. In spite of the undesirable affects on blood lipids, the drug has a profound effect on diabetes. Further research will be conducted on the efficacy of this drug in reducing the risk of developing diabetes.

Just like a referee to normalize play throughout the game - DiaKine Therapeutics is developing ways to normalize the body's immune system.

The new drugs modulate cytokines, part of the body's immune system, which mistakenly attack normal organs and tissue and cause diseases such as: diabetes, multiple sclerosis and inflammatory bowel disease. Research by Dr. Nadler and his collaborators published in 2006 showed that controlling certain cytokines can arrest the progression of, or reverse, type 1 diabetes in an animal model.

The company's first product, IsletLifeLSF Media 1 is designed to improve the viability and insulin producing capabilities of harvested islet cells prior to transplant. This would potentially improve the success rate of the procedure. Additional therapeutics under development by DiaKine include: adjunct therapy to islet cell transplants, halting the progression of type 1 diabetes in newly diagnosed adults, treatment and prevention of Latent Autoimmune Diabetes of Adults (LADA), treatment and prevention of insulin requiring type 2 diabetic, treatment and prevention of diabetes complications.

It all sounds like good stuff in the works. Keep an eye on the progress and press releases of DiaKine, as well as their research partner - the Diabetes Research Institute. A lot is happening these days. What else have you seen or heard about in the autoimmune arena?

Medtronic, one of the largest manufacturers of insulin pumps and continuous glucose monitors, issued a call to action request for insurance companies. The need for greater coverage on continuous glucose monitors is as important (and as necessary) as the rising demand for insulin pumps.

The president of Medtronic's diabetes division, Chris O'Connell, urged the insurance companies to consider the vast growth of the company - which was measured as considerably faster than the industry average, with sales climbing 24% in the last quarter. The device was approved for adult patients last year and U.S. regulators approved an expanded edition for use in children. The continuous glucose monitor alerts diabetics to dangerous spikes or dips in their blood sugar levels via wire-like sensors inserted under the skin that measure glucose levels and transmit the data wirelessly to a pager-size receiver.

The company plans to conduct clinical studies to demonstrate the cost effectiveness of the technology. Presumably, after two to three years of clinical trials, the evidence will be conclusive enough for insurance companies to consent to providing greater coverage for this continuous glucose monitoring.

The Food and Drug Administration recently approved Byetta as an add-on therapy to improve blood sugar control in people with type 2 diabetes who have not achieved adequate control on a thiazolidinedione, or TZD.

Byetta is already approved for treatment of patients with type 2 diabetes who are unsuccessful at controlling their blood sugar levels despite using the commonly prescribed oral medications or insulin. Byetta helps control blood glucose in four different ways. First, it signals your pancreas to make the right amount of insulin after you eat. It also stops your liver from making too much glucose when your body does not need it. It may reduce your appetite and the amount of food you eat. And it helps slow down how quickly food and glucose leave the stomach. It's no surprise that back in May, AMYLIN had to increase their production of Byetta, after realizing demand was outpacing the supply.

Byetta has given type 2 diabetics the reassurance they need to take their diabetes control to the next level. Taking your meds no longer has to come with the dubious consequence of a ravenous appetite. And with this new feather in the Byetta cap-the FDA says it does the trick to improve blood sugar control. The jury's out!

Scientists at Johns Hopkins report a drug commonly used to slow the loss of central vision has shown promise in treating a common precursor of blindness in diabetics.

Researchers injected the drug into the eyes of 10 people losing their sight from macular edema, one of many complications of diabetes and a first stage of diabetic retinopathy. Over the course of several months of therapy, every patient in the study could read at least two more lines on the standard eye chart. The drug used in this study is called ranibuzumab. The researchers believe that ranibuzumab interferes with a protein that spurs the growth of unwanted blood vessels in the back of the eye. Vascular endothelial growth factor, or VEGF, is released when the oxygen supply in the eye is restricted by blood vessel damage related to diabetes. In a self-preserving attempt to acquire more oxygen, the VEGF signals for the creation of new blood vessels, which almost always damage, rather than improve, vision by blocking light's entry onto the retina.

I'm a perfect candidate for this therapy! Every 6 months, when I have my macular maintenance checkup -- I'm dilated, checked and sent on my way. I am going to do a little name-dropping on my next visit and see if I can't get myself one or two more lines on the standard eye chart.

I've mentioned the possibility of oral insulin a few times before, and I'd like to reiterate some exciting news. A recent study confirms that Generex Oral-lyn is as effective as injections in controlling after meal blood sugar rises. The study compared the effects of two forms of mealtime insulin treatments in patients with Type-1 diabetes. The patients were all on 2 daily injections of NPH insulin for long-acting blood sugar control. The study measured the efficacy in treatment of after meal blood sugar spikes.

To treat after meal blood sugar rises, 11 subjects in the control group received three pre-meal injections of regular insulin. The 14 subjects in the treatment group received three split-dose applications of Generex Oral-lyn (i.e. RapidMist puffs of Generex Oral-lyn) before and after meals. The fructosamine and glycated hemoglobin (HbA1c) were checked approximately every 2 weeks to determine the efficacy of treatment. The study demonstrated that both Generex Oral-lyn and mealtime injections of regular insulin achieved near normalization of blood glucose. This measurement was made based on the continuous improvement in fructosamine and HbA1c levels. However, a straightforward comparison of HbA1c levels showed a superior effect for Generex Oral-lyn.

By providing a simple and effective alternative to mealtime insulin injections, Generex Oral-lyn is designed to improve patient compliance which is likely to improve diabetes control, thus reducing the risk of long-term complications. This study prepares Generex for a pivotal late-stage, long-term trial of Generex Oral-lyn which will begin early in 2007. This is sounding more promising with every press release. Thanks to the tenacious women behind the genius of Generex - we won't have to hold our breath too long before we see oral insulin. Way to go, ladies!!

Generex's flagship product, Oral-lyn^TM, is an oral insulin spray for the treatment of type 1 and type 2 diabetes. Their technology permits the delivery of insulin through the oral cavity (with no deposit in the lungs). Whatever you do, don't call it an inhaler.

Oral-lyn^TM is a liquid form of human insulin that is absorbed through the buccal mucosa. Say that three times, fast. It is delivered through the RapidMist^TM device, which looks a lot like an inhaler. But because this device limits absorption to the mouth, there is no entry into the lungs. The rich vascularity of the buccal mucosa allows for much faster absorption of insulin and a shorter total duration of activity which makes Oral-lyn^TM an ideal mealtime insulin, as it can be conveniently administered immediately prior to meals with little prospect of hypoglycemia. Oral-lyn^TM can be used as a preventative agent by people with pre-diabetes to delay the onset of diabetes and by patients with type-2 diabetes to delay the onset of insulin dependence and the complications associated with diabetes.

Generex Oral-lyn^TM is expected to lead to an enormous improvement in the quality of life, with the elimination of pain and a significant increase in convenience. This will result in improved compliance with a relative decrease in complications and a significant reduction in the costs associated with treating them. Knowing now that you can non-invasively continuously monitor your blood sugars, patch on your basal rate, and puff (but not inhale) for your meals - I'm going to do my share of screaming from the hilltops to get these devices the attention they warrant.

Dear Mister FDA, please don't give any of these potential pipeline treatments any shenanigans. They deserve a bedtime story and a kiss on the forehead for the promise they bring to us in the cold, weary world of diabetes. Oh yeah-- and please put a little hustle in it! Yours truly, Allie B