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DATE: December 30, 2005
A recent report in the New England Journal of Medicine describes the cardiovascular benefits of rigorous control of blood glucose by those with diabetes. The report focuses on a fairly simple and extremely important indication: that rigorous control of blood glucose levels not only reduces the best known complications of diabetes – damage to the eyes, nerves and kidneys – but that it also greatly reduces the incidence of heart disease in this disease population. Previous reports issued at conferences of the American Diabetes Association (ADA; Alexandria, Virginia) have pointed to the value of good glucose control for reducing heart disease in this population. But publication in NEJM results in broader dissemination to the public through general news outlets. In summary, the study showed that tight glucose control lowers the risk of cardiovascular disease events by 42% and the risk of a serious event, such as heart attack or stroke, by 58%.
The findings reported in the NEJM story are based on a follow-up study of patients who took part in long term research termed the Diabetes Control and Complications Trial (DCCT) – a study funded by the National Institutes of Health (NIH; Bethesda, Maryland) and its National Institute of Diabetes and Digestive Kidney Disease (NIDDK) unit – and launched about 20 years ago. DDCT involved 1,441 people in a comparison of intensive vs. conventional control of blood glucose, with the initial results rolled out in 1993 and indicating a large reduction (from 39% to 76%) in the development of microvascular complications such as retinopathy, neuropathy and nephropathy. Then a study of DDCT participants released in 2003 showed that steady glucose control had the effect of reducing atherosclerosis. As a subset of the DDCT study, a large majority of the participants (1,375) in DDCT then were enrolled in the Epidemiology of Diabetes Interventions and Complications (EDIC) study, which went on to make annual assessments over an eight year period and has served to produce the more definitive results concerning reduction of heart disease and the lowered occurrence of angina, heart attack and stroke. “We see a greater reduction in cardiovascular events from intensive blood glucose control than from drugs that lower blood pressure and cholesterol,” said Saul Genuth, MD, of Case Western University (Cleveland), chair of the EDIC study.
Besides demonstrating the overall value of strict glucose control for reducing serious cardiovascular events, the study produced a sort of sub category of interesting and clinically important outcomes, chiefly:
This concept could be better established in another study, the Action to Control Cardiovascular Risk in Diabetes (ACCORD), which will test ways to lower the risk of heart disease and stroke in adults with Type 2 diabetes, sponsored by NIDDK and the National Heart, Lung, and Blood Institute. Results of this study are slated to be released in 2009. In the initial DCCT study, patients 13 to 39 years of age were randomly assigned to intensive treatment, which meant attempting to keep glucose levels as close to normal as possible – hemoglobin A1c (HbA1c) readings at 6% or less with at least three insulin injections a day or an insulin pump, guided by frequent self monitoring of blood glucose. (HbA1c reflects average blood glucose over the past two to three months.)
At the end of the study, HbA1c readings averaged 7% in the intensively treated group and 9% in the conventionally treated patients, who were then encouraged to adopt intensive control and shown how to do it. The NIH said that these findings prompted “a major shift” in the way doctors manage their patients with Type 1 diabetes. Among the 1,375 volunteers who continued continuing to participate in the study, the intensively treated patients had 46 cardiovascular disease CVD events, compared to 98 such events for the conventionally treated group. Thirty-one intensively treated patients (4%) and 52 conventionally treated patients (7%) had at least one CVD event during the average 17 years of follow-up from the start of the DCCT. The average age of participants is now 45 years, slightly more than half of them males. <>Nearly 21 million people in the U.S. – 7% of the population – have diabetes, and at least 65% of those with diabetes will die from a heart attack or stroke. But the ADA says that two out of every three with diabetes are unaware of their increased risk. Type 1 diabetes accounts for 5% to 10% of diagnosed cases of diabetes in the U.S. (up to 1 million people). This form of diabetes usually strikes children and young adults, who need three or more insulin injections a day or treatment with an insulin pump to maintain the level of blood glucose control shown to prevent or delay long term complications.
BLOOD-SUGAR CONTROL CAN BOOST HEART HEALTH
DATE: December 23, 2005
A 17-year federal study has finally answered one of the most pressing questions about diabetes: Can tight control of blood sugar prevent heart attacks and strokes?
The answer, reported recently in The New England Journal of Medicine, is yes. Intense control can reduce the risk by nearly half. And, the study found, the effect occurred even though the patients had only had a relatively brief period of intense blood sugar control when they were young adults. Nonetheless, more than a decade later, when they reached middle age, when heart disease and strokes normally start to appear, they were protected.
The study involved those with Type 1 diabetes, which usually arises in early in life and involves the death of insulin-secreting cells. "This is truly an important study," said Dr. Robert Rizza, a professor of medicine at the Mayo Clinic and the president of the American Diabetes Association. "And I usually don't say that," he added. The findings are likely to affect clinical practice, encouraging doctors to put more effort into helping patients control their blood sugar, said Dr. John B. Buse, the director of the diabetes care center at the University of North Carolina. The study is "the most rigorously conducted to date," Dr. Buse said, and its authors are "exceptionally well known in the diabetes and medical world." The question of whether rigid blood sugar control protects against heart disease and strokes has plagued the field for decades, diabetes researchers said. "It's really a major question that has been around for a long time," said Dr. Judith Fradkin, who directs diabetes research at the National Institute of Diabetes and Digestive and Kidney Diseases.
Researchers knew that diabetes was linked to heart disease - at least two-thirds of diabetics die of heart disease. But although studies showed that controlling blood sugar protected against damage to the eyes, kidneys and nerves, there was no conclusive evidence that it would have the same effect on heart disease and stroke.
"In that sense, this is a landmark study," said Dr. William Cefalu, a diabetes researcher at the Pennington Biomedical Research Center in Baton Rouge, La., who wrote an editorial accompanying the paper. The study began with 1,441 people aged 13 to 39. Half were randomly assigned to intensive therapy, intended to keep their blood sugar levels low all the time. That meant injecting themselves with insulin three or more times a day or using an insulin pump to infuse the hormone. The others were assigned to conventional therapy, which meant one or two insulin injections a day, a regimen that was easier for patients but resulted in higher sugar levels. Blood sugar was assessed by measuring the amount of hemoglobin A1c in the participants' blood, a test that looks for hemoglobin with sugar attached to it. The goal for the intensive-therapy group was to keep those levels to 6 percent or less. They achieved an average level of 7 percent. Those assigned to conventional treatment had an average level of 9 percent. Normal levels for people without diabetes are 4 percent to 6 percent. After six and one-half years, both groups were told that intensive therapy had prevented injury to the eyes, kidneys and nerves but that it had not found an effect on heart attacks and strokes. Those who had had the conventional treatment were taught the intensive treatment regimen. Then, for the next 11 years, all the patients were followed but left to their own doctors' care. Soon the two groups had about the same hemoglobin A1c levels, about 8 percent.
As the years went by and the patients started developing signs of heart disease, the researchers noticed a pronounced difference between the two groups in their rates of heart attack and stroke. Thirty-one of the patients who had had intensive treatment when they were young had a total of 46 cardiovascular events, including heart attacks, stroke and heart disease severe enough to require bypass surgery. Fifty-two of the conventionally treated patients had a total of 98 such events."It was amazing," said Dr. David Nathan, a diabetes researcher at the Massachusetts General Hospital who was co-chairman of the study. "Therapy for six and one-half years seems to have driven a dramatic effect." But the result also gives rise to questions: Does the same effect occur in people with Type 2 diabetes, which usually occurs later in life and involves an inability to respond to insulin? And why would tight control of blood sugar for one brief period have such a pronounced effect later? Dr. Fradkin said she expected that the results would hold for Type 2 diabetes. Another large federal study is addressing that question, she noted, but it is already known that tight control of blood sugar in Type 2 diabetes protects against nerve, kidney and eye damage, just as it does with Type 1 diabetes. In addition, a study in Britain hinted, though it did not demonstrate, that Type 2 diabetics who kept their blood sugar low had less heart disease and fewer strokes. But why controlling blood sugar for a brief period would have such a pronounced effect is a mystery, researchers say. "To me, the observation is fascinating," Dr. Buse said. The immediate problem, Dr. Fradkin said, is that fewer than 40 percent of diabetics are keeping their hemoglobin A1c levels at 7 percent or below. Such levels are not easy to obtain, Dr. Cefalu said. "There are side effects - hypoglycemia, weight gain."Hypoglycemia can be frightening, Dr. Fradkin said. Patients get sweaty, they have palpitations and they can even lapse into unconsciousness and have seizures. In addition, the weight gain that often accompanies improved blood sugar control can be disheartening, diabetes specialists said. "It is difficult to get people to comply with four injections a day," Dr. Cefalu said. "Unfortunately, most of our patients are not willing to do this."But, Dr. Fradkin said, she hopes the emerging evidence and improving therapies will make a difference. "We want patients to say to their doctor, 'What is my A1c level? What should it be? And what can I do to get it there?' " Dr. Fradkin said.
By Gina Kolata - The New York Times
DIABETIC FOOT DISEASE IS A WORLDWIDE PROBLEM
DATE: December 16, 2005
A diabetic person carries a lifetime risk as high as 25 percent for developing a foot ulcer, according to research published in a special issue of The Lancet dedicated to diabetic foot disease.
Professor Andrew J. M. Boulton of the Department of Medicine at the University of Manchester in the United Kingdom and colleagues also reported that the global incidence of diabetic foot disease will rise with the increasing incidence of both type 1 and type 2 diabetes.
The costs of diabetic foot disease are staggering. Boulton and colleagues estimated costs of $10.9 billion to US healthcare payers for diabetic foot ulceration and amputations, and a total annual estimated cost of 252 million British pounds for diabetes-related foot complications in the United Kingdom in 2001 based on:
Increased worldwide physician and patient knowledge of diabetes-related foot problems may be the most cost-effective way to prevent serious long-term complications. In fact, many European countries have already implemented some elements of the international guidelines on diabetic foot care, per the International Working Group on the Diabetic Foot, 2003, with some success.
Patients in other regions also are benefiting from outside assistance as well as internal programs designed to prevent and treat diabetic foot disease.
However, significant global disparities of care still exist.
Steps for reducing the incidence of diabetes-associated foot problems may be as simple as running national campaigns to encourage health care professionals to examine their patients' feet.
“Identification of the at-risk foot does not require any expensive equipment: A tuning fork, pin, tendon hammer and a 10-g monofilament should suffice,” Boulton and colleagues wrote. Focusing programs and follow-up care at those patients at risk for developing complications and tailoring education to the patients' understanding and social background, “can improve patients' outcomes, disability, morbidity and mortality.”
To access the full report, visit www.thelancet.com. To access the May 2005 International Diabetes Federation Position Statement on the diabetic foot, visit www.idf.org.
IN THE U.K. - MAGGOTS & SILVER HAVE BEEN SHOWN TO SAVE LIMBS
DATE: December 09, 2005
Elizabeth McCardle, a UK citizen with diabetes, has silver to thank for saving her from having a foot amputated.
Many diabetics suffer from loss of nerve sensation in their limbs and poor circulation. An infected wound or ulcer can lead
to complications, which could end up in amputation. Up to 100 diabetics a week lose a limb this way in England alone.
Elizabeth, 49, from Blantyre, Lanarkshire England, nearly added to the toll after standing on a piece of plastic while walking
round her home barefoot. It buried itself deep in her foot without her realizing. By the time it started oozing, it had become so
infected it was touch and go whether it could be saved. Thanks to maggots, a new type of dressing and Duncan Stang, chief
podiatrist at Hairmyres Hospital near Glasgow England, her foot was saved. "Maggots gobble up bacteria better than some
antibiotics," says Duncan. When they had done their work, he used a pioneering wound dressing called Aquacel Ag,
( www.convatec.com ) which has powerful antibacterial properties to kill infections.
It soaks up fluid - which can be infected with bacteria - that builds up in wounds. Impregnated particles of silver* - which have
antibacterial properties - destroy bugs in the dressing so they can't get back into the wound.
"Elizabeth was fortunate because we discovered her wound had become infected with MRSA, but the silver in the bandage
appears to have killed it," says Duncan. Silver's antibacterial properties have been known for centuries, but it is only recently
that it has been used in wound dressings. "I've had diabetes for 16 years, but the problems with my feet have only happened
in the past few years," says Elizabeth. "I had no idea I had anything in my foot until it had been there for several days. A normal
person would have felt something sharp go into their foot and screamed, but you could put my foot in boiling water and I
wouldn't feel a thing. What happened to me was a warning to be careful and on my guard. Now I'll always wear slippers
around the house."
Source: www.diabetes.org.uk
*Silver is now being incorporated into diabetic socks: Medicool Silverknit Socks
NEW TECHNIQUE IN CELL TRANSPLANTATION SHOWS PROMISE
DATE: December 02, 2005
Researchers are using a new cell transplantation technique to restore the cells that produce insulin in patients with type 1 diabetes. The method is minimally invasive, with few complications. The study was presented this week at the annual meeting of the Radiological Society of North America (RSNA).
"We used ultrasound guidance to inject donor cells into the portal vein of diabetic patients, which is accessed through the skin," said co-author Saravanan Krishnamoorthy, M.D., radiology resident at the University of Minnesota in Minneapolis. "This is a safe method of cell transplantation that could potentially become a same-day procedure."
In type 1 diabetes, the body does not produce insulin. This typically results from the destruction of insulin-producing islet beta cells in the pancreas. Insulin is necessary to metabolize sugar, which is the basic fuel that all cells need. With this minimally invasive technique, donor islet cells are injected into diabetic patients so that the new, healthy islet cells can restore insulin production, essentially stopping the progression of the disease. The study included 13 patients with poorly controlled type 1 diabetes. Fifteen islet cell transplants were completed -- two patients underwent two procedures to achieve correct needle placement.
"We used a steroid-free protocol to suppress the immune system, so that the body accepted the transplanted cells," Dr. Krishnamoorthy said. "We also developed a 'sandwich technique' to close the access site through the skin, where the islet cells are injected. The sandwich technique is so-called because of the layered applications of gelfoam and coil used to close the access site." Dr. Krishnamoorthy said that even though percutaneous islet cell transplantation is currently an experimental procedure, the sandwich closure is a safe method that prevents many of the complications common to previous techniques used to transplant islet cells. Thirty days after the procedure, all 13 patients were producing insulin without requiring supplemental injections, and none experienced major complications. Liver function tests and blood cell counts were monitored carefully during this time. In the future, Dr. Krishnamoorthy looks toward the potential use of stem cells for this purpose, and also the development of better immunosuppressive medications to keep the body from rejecting the transplanted islet cells. Type 1 diabetes, formerly known as juvenile diabetes, is a debilitating disease that is usually diagnosed in children and young adults. It can result in significant morbidity, causing vision loss, loss of sensation that results in severe infections, fractures and amputations, destruction of major organ function (e.g., the kidneys) and cardiovascular disease that can result in complications such as heart attacks. Both genetic and environmental factors contribute to the disease.
RSNA is an association of 38,000 radiologists, radiation oncologists, medical physicists and related scientists committed to promoting excellence in radiology through education and by fostering research, with the ultimate goal of improving patient care. The Society is based in Oak Brook, Ill.
SOURCE Radiological Society of North America
SURVEY SHOWS ALMOST 50% OF PEOPLE WITH DIABETES ARE NOT USING ASPIRIN THERAPY
DATE: November 25, 2005
Survey results released this week by the American College of Preventive Medicine (ACPM) found that nearly half (48%) of U.S. adults 40+ with diabetes are not utilizing aspirin therapy to reduce their risk of recurrent heart attack or stroke nor had they reported discussing such therapy with their healthcare provider. This population is at heightened risk of cardiovascular events, and therefore potential candidates for doctor-recommended aspirin therapy based on current American Diabetes Association and U.S. Preventive Services Task Force guidelines. -- The survey, which was conducted by Harris Interactive in collaboration with the ACPM, was supported by an unrestricted educational grant from Bayer HealthCare, the makers of Bayer Aspirin.
Heart attack and stroke are the most life-threatening consequences of diabetes, occurring more than twice as often among people with diabetes than in those who do not have the disease, and accounting for approximately 65% of deaths in people with diabetes. According to the American Diabetes Association, a diagnosis of diabetes as an adult presents a similar level of coronary heart disease risk as already having suffered a heart attack. The ADA recommends that aspirin be considered for use in the prevention of both first and recurrent cardiovascular events in patients with diabetes who have at least one additional risk factor. Additionally, the USPSTF recommends the consideration of low-dose aspirin in people whose five-year CHD risk exceeds 3%, a point at which the benefits of aspirin therapy are thought to outweigh the risks; the USPSTF recommendations also note that patients with diabetes appear to benefit "as much or more from aspirin as nondiabetic patients." Despite these treatment guidelines, the ACPM survey suggests that aspirin remains underutilized in people with diabetes, an issue that may be due in part to these individuals' tendency to underestimate their risk for a heart attack or stroke.
"The survey findings suggest that insufficient numbers of Americans with diabetes are aware of the cardio-protective benefits of aspirin," commented George K. Anderson, MD, MPH, past president of the ACPM. Although the benefits of aspirin therapy have been proven to outweigh the risks in moderate to high risk populations, it is concerning that so many people with diabetes and at least one additional risk factor -- a population that would stand to benefit from aspirin use -- seem unaware of this fact," said Dr. Anderson. "Clearly, health professionals and patients -- especially patients with diabetes age 40 or older -- need to work together more closely to improve dialogue regarding aspirin therapy as part of a risk-reduction action plan."
It's important to remember that aspirin is not appropriate for everyone, so be sure to talk to your doctor before you begin an aspirin regimen. If you are taking a prescription product for diabetes, it is especially important to talk to your doctor because aspirin can interfere with certain diabetes medications.
Survey Findings and Implications
The results were drawn from a nationally representative on-line survey of 1,299 U.S. adult consumers (647 men, 652 women) age 40 and over and 528 healthcare professionals. The survey was designed to assess barriers, beliefs and behaviors related to adoption of cardiovascular event prevention strategies, with a particular focus on aspirin use and adherence.
Of the 1,299 survey respondents, 198 (approximately 15%) indicated that they have diabetes. Whereas 52% of respondents with diabetes reported that they take aspirin on a regular or daily basis, 11% said they had previously used aspirin for prevention of heart attack or stroke, and 45% said they had never taken aspirin for this purpose. While nearly half of the diabetic respondents said they consider themselves "extremely knowledgeable" about aspirin therapy, only 25% of the diabetic respondents said they strongly agree with the statement, "The benefits of aspirin therapy generally outweigh the risks."
The survey findings suggest that healthcare professionals believe they are discussing the risks and benefits of aspirin therapy with their patients with diabetes more frequently than patients report having this discussion with their healthcare provider. Although the survey did not explore the underlying reasons for patient behaviors, there was a significantly smaller percentage of diabetic respondents reporting aspirin use (52%), as compared with those reporting implementation of lifestyle changes (86%) and use of prescription medication (81%).
"Although the survey did not quantify how often healthcare professionals recommended aspirin, or how many patients received this recommendation, the disparity in consumer and professional responses suggests that many candidates for aspirin need to understand their risk and take action by talking to their doctor about aspirin," said Dr. Anderson. "While this is true for the population as a whole, the need for improved physician/patient communication surrounding aspirin is particularly pronounced for individuals with diabetes, given the heightened level of risk and suboptimal utilization in this patient group."
DERMISONIC'S INSULIN PATCH CLOSER TO APPROVAL
DATE: November 18, 2005
The developer of painless, injection-free, ultrasonic transdermal drug-delivery patches and technologies with broad pharmaceutical and consumer applications, announced this week that it has received approval from the Chesapeake Research Review Investigative Review Board to enter into the next stage of human pilot trials of its proprietary U-Strip(TM) Insulin Patch drug-delivery system in patients with Type-2 diabetes.
The approval is a major step toward identifying Dermisonics as the front-runner in securing federal regulatory approval for injection-free transdermal (through the skin) drug-delivery technologies and positions the Company to become a leader in the $19 billion drug-delivery market segment. Approval for the Company's HPT-2 trials came from the Investigative Review Board (IRB) of the Chesapeake Research Review, an independent biomedical research review organization.
The trials, expected to begin in the first quarter of 2006, will evaluate the use of Dermisonics' proprietary U-Strip (TM) transdermal patch device as an insulin delivery system for Type-2 diabetics. Currently, people with diabetes rely on regular, frequent needle injections of insulin to control blood glucose levels. Dermisonics' patented U-Strip(TM) system employs proprietary microelectronics and ultrasonic technologies with a drug-carrying patch to enable the painless delivery of large-molecule drugs through the skin's natural pores and hair follicles.
"The IRB approval to begin this significant trial provides an important opportunity to validate our proprietary ultrasonic drug-delivery technology," said Bruce Haglund, CEO of Dermisonics. "The Company's U-Strip system is being designed to serve as a safe and painless alternative to injections for delivering a broad range of drugs transdermally, that is, through the skin. Should our trials be successful, we believe Dermisonics' platform technology has the potential to emerge as a leading force in the creation of breakthrough methods to deliver at least 175 existing drugs that would otherwise require uncomfortable, inconvenient or painful injections."
About the Human Pilot Trial 2 (HPT-2) The trial will involve a small group of volunteers, Type-2 diabetes patients, to compare the performance of the Dermisonics U-Strip(TM) Insulin Patch system with an existing FDA-approved insulin pump delivery system. The test will run for approximately three months. The study will evaluate the effectiveness of the Insulin Patch in comparison to conventional pump therapy, with one significant advantage; the U-Strip(TM) Insulin Patch will be totally non-invasive. The results of the study will be presented for publication by peer reviewed medical journals in 2006.
About Diabetes Sufferers When final regulatory approval has been obtained, the U-Strip(TM) Insulin Patch technology has the potential to improve the lives of both Type-1 and insulin dependent Type-2 diabetics, reaching 55 million diabetics, or nearly 30% of the total 185 million diabetic population worldwide, who endure painful needle injections to survive this debilitating disease.
About Dermisonics, Inc.
Dermisonics is an intellectual property company and advanced technology incubator that is primarily focused on the ongoing development, testing and eventual commercialization of a transdermal patch that has been designed to facilitate the efficient and needle-free delivery of drugs with large molecular structures into the bloodstream. Its breakthrough system, called the U-Strip, is based on a radical integration of microelectronics and ultrasonic science with a product-carrying patch, and represents a quantum leap in non-invasive, transdermal delivery technology. Tests have shown that this system facilitates the transdermal delivery of insulin as well as potentially at least 175 other existing drugs that at present cannot be effectively delivered through the pores of the skin using conventionally available transdermal technology due to their large molecular size. The Company has also developed other portable ultrasonic systems for applications in the medical (Antiseptic Wand) and skin care (U-Wand) fields. For more information visit www.Dermisonics.com.
For more specific information about Dermisonics, please visit www.trilogy-capital.com.
PUTTING FEET FIRST HELPS PREVENT AMPUTATIONS
DATE: November 11, 2005
Every 30 seconds a lower limb is amputated as a result of diabetes somewhere in the world, according to the International Diabetes Foundation (IDF). In an effort to reduce the number of amputations among people with diabetes, the American Podiatric Medical Association (APMA) and the National Diabetes Education Program (NDEP) are partnering to recognize and promote World Diabetes Day on November 14. This year's World Diabetes Day theme, "Put Feet First: Prevent Amputations," will focus on preventing lower limb amputations for people with diabetes through education and early identification.
"Knowing what symptoms to look for and how to care for your feet at home are the first steps to preventing amputations," said APMA President Dr. Harold Glickman. "The key is recognizing a potential problem before it becomes a non-healing foot wound or ulcer."
While many serious medical conditions affect people with diabetes, foot problems lead to more hospitalizations than any other complication. Even more startling is the fact that 70 percent of non-traumatic lower limb amputations in the world are attributed to diabetes. Though most amputations begin with a foot ulcer, it is estimated that up to 85 percent of amputations could be avoided with better diabetic foot care.
"Foot complications are among the most serious and costly complications of diabetes. The National Diabetes Education Program (NDEP) is eager to join with APMA in support of IDF's World Diabetes Day 2005 and their efforts to 'put feet first' and prevent amputations," said Dr. Lawrence Blonde, chair of the NDEP. "Working together, we can encourage the more than 18 million Americans with diabetes to take care of their feet -- for a lifetime."
World Diabetes Day, organized by IDF, is the primary global diabetes awareness campaign in the world. It was first introduced in 1991 in response to concern over the escalating incidence of diabetes around the world. Since then, it has grown in popularity and now unites more than 350 million people worldwide.
For more information about amputation prevention and diabetes, please visit http://www.apma.org and http://www.ndep.nih.gov
Founded in 1912, the American Podiatric Medical Association represents the nation's premier foot and ankle physicians. The Association has component societies in 53 locations in the US and its territories and a membership of more than 12,500 doctors of podiatric medicine. For free foot health information, contact APMA at 1-800-FOOTCARE (1-800-366-8227) or visit www.apma.org on the Web.
SOURCE American Podiatric Medical Association; National Diabetes Education Program
CELL TRANSPLANTS IN CANADA HAVE FREED ONLY 15% FROM INSULIN
DATE: November 04, 2005
Five years ago, a group of Edmonton researchers electrified the medical world with news of a treatment that could free patients with severe diabetes from the need for daily insulin injections. But many of those patients are back on the needle today and the team that developed the Edmonton Protocol says there's still a lot of work to do before there's a cure.
The protocol involves transplanting insulin producing cells called islets from a donor pancreas into a patient's liver, where they start to mimic the work of a healthy pancreas. Eighty patients have received such transplants at the University of Alberta. Surgeons around the world have used it on another 500 people. An update on the promising procedure was one item on the agenda of last month's annual conference of the Canadian Diabetes Association and Canadian Society of Endocrinology and Metabolism.
About 2,000 doctors, researchers and educators met in Edmonton to discuss the latest work on diabetes, which affects an estimated 2.2 million Canadians. Of those who have received islet transplants, half remain free from insulin injections after three years and 15 per cent are insulin free after five.
"That's obviously a disappointment and a lot of efforts are now being directed at why that is," team member Dr. Eddie Ryan said. "Cells are working, but they're not working well enough that these people can stay off insulin."
Several reasons are being investigated: the body's immune system may be working against the transplanted cells, some of the cells aren't functioning properly in the liver and some of the immuno-suppressive drugs patients must take are actually hampering the cells' ability to make insulin. "That's really a whole new focus of the research in all the centers across the world," he said. "How can we get these cells to work better?"
Despite the setbacks, Ryan said islet transplants still offer much for the small percentage of Type 1 diabetics who can't control the highs and lows in their blood sugars no matter how carefully they regulate diet, exercise and medication.
"I had one person come to me and when I asked them what they wanted from the transplant, they said, 'I want to go to bed not wondering whether I will wake up looking at the paramedics.' That sort of person I can help and that's the sort of person the islet transplant has helped."
WORLD HEALTH ORGANIZATION SAYS DIABETES BIGGER THREAT THAN BIRD FLU
DATE: October 28, 2005
Diabetes looms as a larger health threat to Asians than bird flu, the World Health Organization said Wednesday, with data showing the disease will cause millions more deaths worldwide in the coming decades. "This is a global diabetes tsunami, a catastrophe, that will become the health crisis of the 21st century and could reduce life expectancy globally for the first time in 200 years," said Paul Zimmet, director of WHO's Collaborating Center for Diabetes and the International Diabetes Institute in Australia. A new WHO report, "Preventing Chronic Diseases: A Vital Investment," shows chronic diseases, dominated by diabetes, cause twice as many deaths as infectious diseases, maternal-perinatal conditions and malnutrition combined.
Without action, WHO said 388 million people globally will die from chronic diseases such as diabetes and heart disease in the next decade. Zimmet said Asia was at the heart of a global health crisis, brought about by the "Coca-Colanization" and "Nintendoization" of its countries. Based on current trends, Asia is likely to suffer social and economic devastation from an escalating diabetes epidemic, he said in a statement. Zimmet said new research shows worse medical outcomes for patients with both infectious disease and diabetes. For example, medications for HIV are causing diabetes and increased risk of heart attacks, he said. Zimmet is in Bangkok to attend the International Diabetes Federation Western Pacific Congress.
Diabetes is a chronic disease caused by an inherited or acquired inability to produce enough insulin. It results in high concentrations of glucose in the blood, which can damage many of the body's systems, in particular blood vessels and nerves. Diabetes is among the leading causes of kidney failure, and heart disease accounts for 50 percent of all deaths of people with diabetes in industrialized countries, according to WHO.
PAIN FREE JABS BEING DEVELOPED IN THE U.K.
DATE: October 21, 2005
Squeamish patients who cannot stand needles can relax thanks to the work of South Wales scientists. Cardiff University academics have developed new ultra-thin needles that can deliver injections without causing any pain. The new micro-needles are long enough to penetrate into the body but will not reach pain receptors under the skin. Vitally for anyone who cannot bear to look at a needle, they come in a harmless-looking patch which is smaller than a penny coin.
Lead academic Dr James Birchall, of the Welsh School of Pharmacy in England, who also hates needles, said the micro-needles could be used for almost any injection, including insulin for diabetics and vaccines. He said: 'Trials have already been done in which insulin was successfully injected." A team of seven have been working on the project at Cardiff University for several years alongside academics across the world and a team in Cork, Ireland, where the needles are made. Dr Birchall said it would take around five years of testing before the patch needles could be marketed but that he hoped they could be competitively priced with a conventional syringe. He said: "One of the most important things is that they can be self-administered, removing the problem they have in parts of Africa were there are not enough doctors to administer necessary vaccines." <>
The team at Cardiff has been using left-over skin from patients who have had operations at hospitals in South Wales - with their permission. Dr Birchall said: 'It is all above board. The skin would just be thrown in the bin.': 'I fainted looking at needles':When i was studying A-level biology, I fainted at the sight of a needle in a video on diabetes, writes Echo reporter Lauren Turner. I was the type to turn deathly white having an injection and wouldn't have my ears pierced, such was my fear of needles. How ironic then, that last November I was diagnosed with Type 1 diabetes. And from March this year, I've had to inject myself in the stomach with insulin twice a day. Hearing that a new micro-needle has been developed to make injecting easier is fantastic news. True, the needles I use are so fine they aren't meant to hurt, but you can still feel it - and it's not very pleasant. For people like me who don't like needles, and for parents of children with diabetes, this new invention could be a Godsend. Diabetes can be enough of a pain to fit into your life, so eliminating pain from injections is welcome news.
SCIENCE GETTING CLOSER TO PREVENTING DIABETES
DATE: October 14, 2005
Researchers at Bristol University in England are close to finding a way to stop people from developing Type-1 diabetes. The team of scientists based at the university's Department of Medicine have been working for five years on a vaccination that works by stimulating the production of cells that help restore the body's insulin-producing system. Diabetic patients have already been recruited to test the revolutionary vaccine which has the potential to wipe out the disease. Consultant senior lecturer at the university's Department of Medicine Colin Dayan said the research had reached an exciting and critical point. He said: "We have developed a vaccination that can be given to children who have, or are likely to get, Type-1 diabetes.
"We think that we can detect the cells that cause the disease and destroy the insulin cells that store the food in the blood. The vaccination works by slowing down the disease so that it does not destroy so many cells. If we give it to people when they still have 20 per cent of their insulin-producing cells left, the cells have the chance to re-grow." Dr Dayan said the research was at a very tentative stage but similar studies on animals had already proved successful. He said: "We are now going to give the vaccination to people who have had diabetes for a long time to see if it will change their cells. It will not cure them of diabetes but we will be able to see if it makes a difference." The research team are planning to start tests on 72 people with Type-1 diabetes in the Bristol area soon. They are looking for volunteers who have had the disease for more than five years. Dr Dayan said if the tests were successful the vaccination has the potential to stop children developing diabetes. He said: "We can now detect people who are going to get diabetes five to 10 years before they develop it, but we don't do anything because there is nothing we can do to prevent it. But if this vaccination works we could give it to people and stop them developing diabetes." The prospect of a vaccine has been welcomed by Ken Jaaback, 36, who has had diabetes since he was 11 and has been treated at St. Michael's Hospital in Bristol. "The vaccination sounds very exciting, I just wonder how long it will be before it becomes mainstream. I think there will be a time when diabetes is eradicated but I don't know when. When I was diagnosed they said there would be a cure in 10 years and that was 25 years ago."
U.S.-JAPANESE TEAM SUCCEED IN MASS PRODUCING INSULIN-MAKING CELLS
DATE: September 30, 2005
Tokyo News Report: A Japan-U.S. medical research team has developed a method to mass produce insulin-secreting cells for transplantation to Type 1 diabetic patients who suffer from a genetic condition that prevents the pancreas from secreting the blood sugar-controlling substance. This is "one step toward a potential cure of diabetes by transplantation," the researchers said in their report published in the latest edition of the Nature Biotechnology magazine.
It is known that Type 1 diabetes, which is also called insulin dependent diabetes, is caused by the destruction of insulin-producing pancreatic beta-cells by wrongfully programmed autoimmune responses. Because no insulin is secreted, people with type 1 diabetes require insulin injections several times a day to keep blood sugar at normal levels. If sugar levels are not controlled, various complications such as retinopathy-caused blindness, kidney failure and peripheral nerve disorder can occur. But the insulin injection treatment is a burden on diabetics and lowers their quality of life, which is why pancreas transplantation has been regarded as the most promising way to cure the disease. One big problem for organ transplantation therapy however, is the serious shortage of donors. To resolve the donor problem, the researchers, including those from Japan's Okayama University and the Rosalind Franklin Comprehensive Diabetes Center in the United States, favored the idea of giving patients cultured insulin-producing b-cells instead of transplanting entire pancreas.
The pancreatic cell transplantation therapy is not a new idea, with some researchers already trying to make a b-cell line in vitro from embryonic and stem cells, which have the potential to develop into various tissues. But experiments using stem cells have so far failed to yield favorable results, as the b-cells hardly increased. In view of the failures, the Japan-U.S. team tried to achieve continued b-cell expansion by developing a method of immortalizing the cells. "Our strategy was to transform human primary b-cells with immortalizing genes and screen for clones that were not tumorigenic and that expressed insulin and b-cell-associated factors," the group said. "We now report that our reversibly immortalized pancreatic b-cell clone secretes insulin in response to glucose stimulation." In addition to nonstop expansion of the cell line, the researchers confirmed that transplantation of the cells resulted in "perfect control of blood glucose" in diabetic mice, which were kept healthy for longer than 30 weeks. "This cell line offers continuous availability, uniformity and sterility, and may provide a source of b-cells for the treatment of type 1 diabetic patients by transplantation," the group concluded.
NEW PFIZER DRUG HELPS WITH DIABETIC NEUROPATHY PAIN
DATE: September 23, 2005
Pfizer Inc.has begun selling a new drug that could help millions of people with chronic nerve pain and seizures. Developed at Pfizer's Ann Arbor research facilities, Lyrica is approved by federal regulators to treat three specific ailments: the nerve pain associated with diabetic neuropathy, nerve pain that often accompanies shingles, and for partial onset seizures, the most common type of epileptic seizure. "These three indications will meet the needs of potentially millions of patients," Toni Hoover, who has led the Lyrica development team since 1998.
Lyrica's Class 5 classification -- lowest of all for controlled substances -- puts it in the same category as some cough medicines with codeine, for example. Physicians and pharmacists will follow slightly different procedures in prescribing and tracking the medication, but "patients should not experience any difference," Hoover said. Nearly half of the 18 million American with diabetes will develop some form of diabetic neuropathy and about 3 million will experience painful neuropathy in their feet, legs, hands or arms. An estimated 50,000 Americans develop nerve pain from shingles, a skin disease caused by reaction to the same virus that causes chicken pox. Lyrica is the next generation drug in a class developed and controlled exclusively by Pfizer -- alpha-2 delta ligands. Lyrica works like a blanket, dampening hyper-excitable nerve endings that cause not only pain and seizures, but also psychiatric disorders such as anxiety. <>
One application -- to treat general anxiety disorder -- initially was rejected by the FDA. Pfizer continues to work with regulators, but has not resubmitted an application. However, Pfizer has filed an application in Europe seeking approval for the use of Lyrica to treat general anxiety disorder. The approval process is expected to take about a year.
Developed from a chemical acquired from Northwestern University in 1992, Lyrica has been created almost entirely in Ann Arbor -- first in the research and development labs of Parke-Davis, then Warner-Lambert, then Pfizer, as each was swallowed by its successor. Developed from a chemical acquired from Northwestern University in 1992, Lyrica has been created almost entirely in Ann Arbor -- first in the research and development labs of Parke-Davis, then Warner-Lambert, then Pfizer, as each was swallowed by its successor.
RESEARCH IN EUROPE VITAL TO DIABETES CURE
DATE: September 16, 2005
A major international conference on diabetes has been under way in Athens Greece this week as medical practitioners and scientists presented and analyzed hundreds of research studies on the condition. More than 1,300 papers were presented at the 41st annual meeting of the European Association for the Study of Diabetes (EASD). Around 12,000 scientists from all over the world attended.
"Europe already has a strong research base, however, a concerted and accelerated European research effort is urgently needed to find new solutions for the effective prevention and treatment of this debilitating and life threatening disease" said Dr Viktor Jorgens, EASD executive director. "Such innovative research will not be possible without significant non-government support," he added. About 194 million people are estimated to have diabetes, according to the International Diabetes Federation's most recent global figures. "The anticipated global epidemic of diabetes will impose a great financial strain on the health economy of many countries as well as on the individual with diabetes, who will be affected in terms of quality of life due to the management of a complex disease and its complications," warned Prof Christian Berne of the Institute of Medicine at Uppsala University in Sweden. Prof Berne is addressing the conference on "Building a national diabetes program and strategy - the burden of diabetes." He said that most people with diabetes were in developing countries. Most of the burden of diabetes was due to complications of the condition with cardiovascular disease being the leading cause of death. But retinopathy, nephropathy and neuropathy were also serious threats to the future health and quality of life of the person with diabetes, he said.
Recent European data showed that in coronary care units more than 50 per cent of the patients had diabetes or impaired glucose tolerance (IGT). While diabetes was usually associated with insulin dependent type 1, (ie they must be given insulin artificially), 85-95 per cent of the total diabetes prevalence was due to type 2 diabetes. Type 2 diabetes is associated with resistance to the insulin that the body produces. Sometimes the condition can be managed without administering insulin artificially. Underlying the increased prevalence of type 2 diabetes were obesity and physical inactivity, which had evolved from social and cultural changes of recent years. "Unhealthy lifestyle, urbanization with crowded living conditions, social deprivation, stress and unemployment may also be important underlying causes," said Prof Berne. He predicted that diabetes in pregnancy would affect an increasing number of women. "The reported prenatal mortality is thre to six times higher than in non diabetic women, in part due to congenital malformations, the prevention of which requires meticulous planning," Prof Berne said. He said public health services needed to focus on prevention to reduce the burden of diabetes on the individual and on society. "Recent large-scale trials have shown this to be possible," he said.
The EASD aims to support high quality research in Europe to find a cure for all types of diabetes and associated complications. The annual meeting of the 5,000-strong association is held in a different country each year.
ELI LILLY'S DECISSION TO DISCONTINUE PORK INSULIN UPSETS SOME U.S. & CANADIAN CUSTOMERS
DATE: September 09, 2005
Brent Hoadley counts himself among a small number of diabetics upset that Eli Lilly and Co. has yanked away one of their lifelines to good health, the last animal-sourced insulin sold in the United States. A retired horticulture professor in Lamont, Fla., Hoadley found out last month that Lilly will stop selling Iletin pork insulin when existing supplies run out later this year. Hoadley criticized the Indianapolis drug maker this week for not trying to find a way to keep producing small batches of pork insulin for its 2,000 U.S. and 400 Canadian customers. The two countries are the last markets where Lilly sells the once widely used Iletin brand.
"They could have had production once a year of animal insulin and kept everyone happy. (But) they don't want (to sell) the lower-priced animal (insulin)," Hoadley said. "They want to move to patented products," he said, which carry higher prices and have far more users.Lilly officials said they know of no firm trying to offer a replacement animal-derived insulin in the U.S. market. But in Canada, Lilly has pledged to help Indian drug maker Wockhardt Ltd. offer a replacement pork insulin. Lilly's help is limited to "guidance and advice" about winning government product marketing approval, company spokeswoman Marni Lemons said, and doesn't include sharing any manufacturing technology. <>
Hoadley said that once he uses his small stockpile of Iletin he probably will import pork insulin from Britain, using a special federal drug import permit for which he has yet to apply. A more drastic option, he said, is to move to Australia, where pork insulin still is sold.The dwindling numbers of Iletin users prompted Lilly's decision to end sales, Lemons said. Actual human users are even fewer than 2,400, she said, since a significant amount is bought for diabetic dogs or cats. <>
The disappearance of animal insulins made from ground-up pancreas glands from slaughtered livestock completes the takeover of the North American market by biosynthetic insulins that were introduced in the mid-1980s. The new insulins are made using gene-cloning technology. Lilly's two major brands are Humulin and Humalog. Dr. John A. Hunt, a semi-retired diabetes doctor in Vancouver, said he regrets that the biosynthetics have pushed animal insulins off the market because he has found some patients can control their blood-sugar levels better using insulin from pigs or cattle. Hunt said he treats about 25 patients with animal insulin and they now will have to find another source for it. "I've got a lot of really unhappy people around here," he said. Wockhardt in 2003 bought CP Pharmaceuticals, a manufacturer of pork and beef insulin in Great Britain, where animal-derived insulin remains more widely used than in the United States and Canada.
FDA ALLOWS HEALTH CLAIM FOR CHROMIUM PICOLINATE USE IN TYPE 2 DIABETES
DATE: September 02, 2005
The U.S. Food & Drug Administration (FDA) issued a favorable response to a qualified health claim petition filed by Nutrition 21, recognizing chromium picolinate as a safe nutritional supplement that may reduce the risk of insulin resistance and possibly type 2 diabetes. In a letter to the Company, the FDA's Center for Food Safety and Applied Nutrition concluded that there is credible evidence to support the following qualified health claim:
"One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain."
The FDA declined to permit other qualified health claims that were proposed by the Company. "The FDA's initial response, while a starting point, is an important milestone in our Company's effort to communicate the health benefits of our products, said Gail Montgomery, President and CEO of Nutrition 21. "We expect several conclusive peer-reviewed studies to publish in the months ahead that should help build evidence to support additional health claims for chromium picolinate as the first recognized supplement that may reduce the risk of insulin resistance and possibly type 2 diabetes." Nutrition 21 holds the patent rights for those applications.
The study cited by the FDA was conducted by William Cefalu, MD, chief of the division of nutrition and chronic diseases at the Pennington BioMedical Research Center, Louisiana State University System. "Emerging research suggests that 200-1,000 mcg of chromium as chromium picolinate may play an important role in carbohydrate metabolism," said Cefalu. The FDA also concluded that chromium picolinate is safe, stating the following:
"FDA concludes at this time, under the preliminary requirements of 21 CFR 101.14(b)(3)(ii), that the use of chromium picolinate in dietary supplements as described in the (approved) qualified health claims discussed in section IV is safe and lawful under the applicable provisions Act."
Insulin resistance is an epidemic condition that dramatically increases risk for type 2 diabetes, coronary heart disease and stroke, estimated to affect one in three Americans, according to The American College of Endocrinology (ACE) and the American Association of Clinical Endocrinologists (AACE). "The FDA ruling confirms our strategic investments in clinical research to differentiate Chromax® and Diachrome® from other chromium supplements," added Montgomery. "This qualified health claim should help health professionals and millions of consumers make better informed choices about reducing the risk of insulin resistance with chromium picolinate supplementation and possibly reducing the risk for type 2 diabetes."
because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. Health claims describe a relationship between a food, food component, or dietary supplement ingredient, and reducing risk of a disease or health-related condition. By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims.
The FDA will allow appropriately qualified health claims for dietary supplements as well as conventional foods, when the link between the substance's ability to reduce the risk of the disease does not meet the standard of "significant scientific agreement." According to the FDA's website, these qualified claims are based on the weight of the scientific evidence, i.e., there is more evidence for than against the relationship.
Nutrition 21 is a nutritional bioscience company and the maker of chromium-based supplements with health benefits substantiated by clinical research. The company markets Chromax® chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 holds 36 patents for nutrition products, 27 of which are for chromium compounds and their uses. More information is available at www.nutrition21.com
CONTINUOUS HOME GLUCOSE MONITORING MOVES A STEP CLOSER
DATE: August 26, 2005
DexCom, Inc. of San Diego California has announced the completion of two clinical and regulatory milestone studies of an 86-patient, 21-day trial in the United States with its Short-Term Continuous Glucose Monitoring System (STS) that evaluated performance over 3 consecutive 7-day periods. Patients inserted the STS sensors themselves, wore them in their daily activities at home and work, and were allowed to view and utilize the real-time continuous glucose data from the STS System.
The study demonstrated that the STS System functioned reliably over a 7-day period without a decline in sensor performance or any signs of infection at the insertion site. Although the specific regulatory path and timing are not yet determined, the company intends to seek U.S. Food and Drug Administration (FDA) approval for a 7-day STS sensor, in addition to the 3-day STS system currently under review. DexCom expects the data from this study to be presented or published by the study investigators in the future.
"Since we filed our PMA [premarket approval application] for the 3-day STS Continuous Glucose Monitoring System in March, we have continued to further develop the product platform and underlying technology," said Andy Rasdal, president and CEO of DexCom. "We have been able to leverage technology developed as part of our long-term implantable sensor program to the STS product platform and demonstrated with this latest study that our STS product functioned reliably for a 7-day period. While we continue to believe that our 3-day STS system currently under review by the FDA could represent a significant breakthrough in the management of diabetes, we also believe a sensor that needs to be replaced only once per week would offer a new level of convenience in disease management to people with diabetes."
DexCom also announced that the company had its 100-day meeting with the FDA in regard to its PMA application for the STS Continuous Glucose Monitoring System currently under review by the FDA. The 100-day meeting is a regulatory meeting where the FDA reviews the status of the PMA application with the company and typically makes requests for additional information. At this 100-day meeting, the FDA made requests of DexCom for additional analysis and
information to support its STS PMA filing. In accordance with normal FDA procedures, the FDA will be outlining these requests in writing in what is called a major deficiency letter. DexCom considers all of the requests made at the meeting to be readily answerable and expects to provide the requested information in an expeditious manner. The FDA did not make any request for DexCom to conduct additional clinical studies.
"Since May, when our STS PMA was accepted as filed and granted expedited review status, we have had an interactive and timely review with the FDA," said Rasdal. "We believe the 100-day meeting was very productive and continued to further the common understanding between DexCom and the FDA regarding our STS PMA application and continuous glucose monitoring."
DARK CHOCOLATE MAY HELP REDUCE BLOOD PRESSURE - EVEN HELP IMPROVE INSULIN RESISTANCE
DATE: August 12, 2005
If you have high blood pressure, a daily bar-sized serving of flavonol-rich dark chocolate might lower your blood pressure and improve insulin resistance, researchers report. "Previous studies suggest flavonoid-rich foods, including fruits, vegetables, tea, red wine and chocolate, might offer cardiovascular benefits, but this is one of the first clinical trials to look specifically at dark chocolate's effect on lowering blood pressure among people with hypertension," said study author Jeffrey B. Blumberg, PhD, whose findings were published in the August 2005 issue of Hypertension. Blumberg is a senior scientist at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston. Flavonoids are natural antioxidants found in many foods from plants. "This study is not about eating more chocolate," Blumberg cautioned. "It suggests that cocoa flavonoids appear to have benefits on vascular function and glucose sensitivity."
Blumberg and colleagues at the University of L'Aquila in Italy, including senior author Dr. Claudio Ferri, studied 10 men and 10 women. They all had hypertension and a systolic blood pressure between 140 and 159 mm Hg and a diastolic blood pressure between 90 and 99. None of the participants was taking antihypertensive medicines, and none had diabetes or other disease, nor did they smoke. For one week before starting the study, participants avoided all chocolate and other flavonoid-rich foods. During the next 15 days, half ate a daily 3.5-ounce bar of flavonoid-rich dark chocolate, while the other half ate the same amount of white chocolate. After another week of avoiding flavonoid-rich foods, each subject "crossed over" and ate the other chocolate. "White chocolate, which has no flavonoids, was the perfect control food because it contains all the other ingredients and calories found in dark chocolate," Blumberg said. "It's important to note that the dark chocolate we used had a high level of flavonoids, giving it a slightly bittersweet taste. Most Americans eat milk chocolate, which has a low amount of these compounds."
The researchers found a 12 mm Hg decrease in systolic blood pressure and a 9 mm Hg decrease in diastolic blood pressure in the dark chocolate group after 15 days. Blood pressure did not decrease in the white chocolate group."This is not only a statistically significant effect, but it's also a clinically meaningful decline," Blumberg said. "This is the kind of reduction in blood pressure often found with other healthful dietary interventions."The researchers reported that the dark
chocolate group also experienced a significant reduction in several measures of insulin resistance compared to the white chocolate group. Levels of LDL ("bad") cholesterol dropped by about 10% in the dark chocolate group, but stayed the same in the white chocolate group. "The findings do not suggest that people with high blood pressure should eat lots of dark chocolate in lieu of other important blood pressure-reduction methods, such as medication and exercise," Blumberg said. "Rather, we are identifying specific flavonoids that can have a benefit on blood pressure and insulin sensitivity." He said these results can generate improved dietary recommendations that will help people regulate these risk factors. Blumberg said flavonoid-rich foods should be part of an overall healthy diet, and that some dark chocolate could be part of that effort, as well as fruits, vegetables and whole grains.
This kind of positive finding in a carefully controlled but small study needs to be replicated, Blumberg said."We should also look at patients with other forms of hypertension, as well as people who have coronary artery disease, type 2 diabetes or a high-normal blood glucose level." <>
Source: Diabetes Week -- 08/17/05
PATIENTS WITH DIABETES MAY REDUCE RISK OF VISION LOSS WITH NEW ORAL MEDICATION
DATE: August 05, 2005
A multicenter international study chaired by a Joslin Diabetes Center investigator brings hopeful news to the 18 million people in the United States - and millions more worldwide - with type 1 or type 2 diabetes. Initial results of the Phase III clinical trial demonstrated that 32 mg per day of ruboxistaurin (RBX) was well tolerated and may reduce the risk of moderate vision loss, especially in patients with diabetic macular edema.
Loss of vision is a common complication of diabetes and results from two primary conditions: diabetic retinopathy and diabetic macular edema. In diabetic retinopathy, tiny blood vessels in the retina become damaged. While early in the disease (the nonproliferative stage) there are often no symptoms, over time new, abnormal blood vessels proliferate and bleed easily. If untreated, proliferative diabetic retinopathy can cause severe vision loss. In diabetic macular edema, leaky blood vessels cause swelling in the macula - the part of the retina responsible for sharp central vision. Current laser treatments for diabetic eye diseases may help prevent severe vision loss, but because the laser destroys areas of the retina, side effects of treatment may include reduction in peripheral vision or night vision.
The purpose of the PKC-Diabetic Retinopathy Study (DRS) was to evaluate the safety and effect of an oral treatment, RBX, on retinopathy progression or visual loss in patients with moderately severe to very severe nonproliferative diabetic retinopathy. In the double-masked, randomized multiple-dose study, 252 patients with type 1 or type 2 diabetes received either RBX or a placebo over a period of 3-4 years. The study measured the effect of three orally administered doses of RBX (8, 16 or 32 mg/day) on progression of diabetic retinopathy, moderate visual loss and sustained moderate visual loss. The study was conducted at Joslin Diabetes Center, medical centers across the United States as well as in Canada, Denmark, the Netherlands and United Kingdom.
The findings were published in Diabetes.
The oral treatment RBX inhibits, or blocks, the activity of an enzyme called protein kinase C. PKC is essential to the normal production of energy in the body, but a specific form of the enzyme - PKC-beta - has been linked to diabetic complications of the eye and other parts of the body. Thus RBX was designed to be selective for the single PKC-beta isoform, a fact that contributes to the inhibitor's excellent safety profile, according to the researchers. "Our results demonstrate that although RBX did not prevent progression to proliferative diabetic retinopathy, it may reduce the risk of moderate vision loss caused by macular edema," said study chairman Lloyd Paul Aiello, MD, PhD, head of Joslin's Section on Eye Research, director of Joslin's Beetham Eye Institute and Associate Professor of Ophthalmology at Harvard Medical School. "If these findings hold true in a currently ongoing larger clinical trial, then RBX may eventually offer a new treatment option for patients with diabetes, especially in light of the lack of serious side effects reported to date. "Joslin has a long history of PKC research which has made significant contributions toward the work, which ultimately made evaluation of this inhibitor possible," said Aiello. Indeed, the laboratory of George L. King, MD, Joslin's director of research and head of the Section on Vascular Cell Biology, has studied PKC for 2 decades and was the first to hypothesize that activation of PKC - especially the beta isoform - is the major signaling pathway stimulated by hyperglycemia (high blood glucose associated with diabetes). In diabetic animal models, the lab also showed that abnormal activation of PKC is an important factor in decreasing blood flow to the retina. These seminal discoveries established the link between hyperglycemia, PKC and diabetic eye disease. Having established this link, King began working with scientists at Eli Lilly to design a chemical inhibitor for the PKC-beta isoform. It was from this collaboration that RBX emerged. King and Aiello also collaborated on a number of PKC retinal studies that provided further evidence of the link between PKC and blood vessel abnormalities of the eye, conditions that improved following treatment with the PKC-beta inhibitor.
The PKC-DRS study was funded by Eli Lilly and conducted by the PKC-DRS Study Group.
This article was prepared by Diabetes Week editors from staff and other reports.
INHALED INSULIN STUDY NOW IN SECOND PHASE SHOWS POSITIVE RESULTS
DATE: July 29, 2005
Eli Lilly and Company and Alkermes, Inc. reported detailed results from a phase 2 clinical study of inhaled insulin in people with type 1 diabetes, showing that patients using the Lilly/Alkermes inhaled insulin system achieved blood sugar levels similar to patients treated with injected insulin. In addition, 80% of patients in this study expressed a preference for the Lilly/Alkermes inhaled insulin system at mealtime over injected insulin.
Using the standard measure of blood sugar, A1C, patients achieved an average level of 7.9 using the Lilly/Alkermes inhaled insulin system, compared to 8.0 in the injected insulin group. A1C is an average measure of blood sugar (glucose) over a 3-month period.
The study was designed to evaluate whether inhaled insulin delivered through the Lilly/Alkermes system and injected insulin showed similar effectiveness at controlling blood sugar based on dosing regimens commonly used in the every day management of diabetes. These findings were presented at the 65th Annual Scientific Sessions of the American Diabetes Association. Researchers also presented results from a phase 1 dose response and equivalence study, which showed that the Lilly/Alkermes inhaled insulin system and injected insulin lispro were generally well tolerated and the overall effect on blood sugar was similar, illustrating that doses could be reliably correlated. This is the first comparative study of dose equivalence between inhaled insulin and insulin lispro, a rapid-acting insulin analog and a commonly used mealtime insulin.
"Our goal is to provide patients with an innovative product that offers a more acceptable treatment option for patients and may enable them to achieve better blood sugar control, a key aspect in managing diabetes," said Dr. Douglas B. Muchmore, medical fellow, Eli Lilly and company. Muchmore continued, "These studies, taken together, show that inhaled insulin delivered by the Lilly/Alkermes system is equivalent in various clinical measures to injected insulin. The Lilly/Alkermes Alliance is committed to conducting additional studies needed to confirm the safety and efficacy of inhaled insulin."
Lilly and Alkermes established an alliance in 2001 to develop an inhaled insulin system that delivers human insulin inhalation powder (known as HIIP), based on Alkermes' AIR pulmonary drug delivery technology. The Lilly/Alkermes program is focused on developing an innovative treatment option that can address the challenges associated with managing type 1 and type 2 diabetes. The HIIP delivery system uses a small, simple inhaler that fits in the palm of a hand.
"Despite the health benefits of tight blood glucose control, some physicians and patients are reluctant to initiate insulin therapy. Delaying insulin treatment can contribute to higher blood sugar levels, which can lead to complications such as nerve damage, vision loss and kidney disease," said Dr. Satish Garg, chief of young adult clinics at the Barbara Davis Center for Childhood Diabetes and professor of pediatrics and medicine at the University of Colorado School of Medicine Health Sciences Center. Garg continued, "These studies suggest that inhaled insulin, such as the Lilly/Alkermes system, may encourage patients to move more quickly to a therapy that best improves glucose control."
The studies will be conducted with approximately 1,000 patients at multiple sites in the United States, Canada, Mexico, Argentina, Belgium, Bulgaria, Columbia, Chile, Croatia, Denmark, Hungary, India, Taiwan, Thailand, Singapore and the Philippines. The studies will be up to 24 months duration and will include patients with Type1 and Type2 diabetes who also have chronic obstructive pulmonary disease or asthma, as well as patients with Type1 diabetes without lung disease. Alkermes, Inc., is a pharmaceutical company that develops products based on sophisticated drug delivery technologies to enhance therapeutic outcomes in major diseases. Eli Lilly and Company is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations.
Source: Diabetes Week
EARLY & AGGRESSIVE DIABETES TREATMENT URGED
DATE: July 15, 2005
A pair of physicians groups has now recommended increasingly aggressive treatment for newly diagnosed diabetes patients.
While lifestyle changes, such as losing weight, exercising and watching the diet are often recommended for people with
Type 2 diabetes, the new recommendations urge physicians to treat the disease aggressively early, often with two or more drugs.
"The goal is to quickly get blood sugar levels as close to normal as possible", said Dr. Harold Lebovitz of SUNY Downstate
Medical Center in New York. In addition, people at high risk for developing diabetes should be screened starting at age 30,
the American College of Endocrinology and the American Association of Clinical Endocrinologists said.
If we don't get them diagnosed early we miss an opportunity to prevent complications later in life," said Dr. Jaime A. Davidson
of the University of Texas Southwestern Medical School in Dallas.
Complications from diabetes can include heart and nerve disease, eye damage and amputation of limbs.
The recommendations focus largely on Type 2 diabetes, the more common form of the illness, in which the body either doesn't
produce enough insulin, or doesn't use it correctly. Type 1 diabetes, in which the body simply doesn't produce insulin, always
requires treatment with drugs.
The groups estimate that more than 20 million Americans are diabetic, though as many as one third don't know it. In addition
they said 41 million are believed to have pre-diabetes, an impaired sugar tolerance that can lead to diabetes. "The reason we
are here is because we have a lot of work to do," Davidson said in announcing the recommendations.
ELI LILLY TO DISCONTINUE MANUFACTURING OF FOUR INSULIN PRODUCTS AT END OF 2005
DATE: July 08, 2005
Eli Lilly and Co. is dropping four products used by 2 percent of the nation's insulin-dependent diabetic patients. They are:
Eli Lilly and Co. put out the word yesterday that it is discontinuing U.S. sales of four insulin products, including its remaining animal-based insulins.
The products being dropped have low or falling sales and are used by about 68,000 diabetics. They will have until the end of the year to find replacement insulins, as inventories of the Lilly products are used up. "We are just interested in making this transition as smooth as possible for patients," said Dr. Scott Jacober, a medical adviser in diabetes care for Lilly.
The Indianapolis drug maker will tell doctors, patients, medical groups, diabetes trade publications and others that it is deleting Lente and Ultralente formulations of Humulin and its regular and NPH forms of Iletin pork insulin. The two Humulin formulations, which have seen a 70 percent drop in sales the past four years, are used by about 66,000 people, Lilly spokeswoman Marni Lemons said. The Iletin brands are purchased by just 2,000 people and Lilly suspects that "a significant number of them" are buying the products for their diabetic dogs or cats, Lemons said. Iletin was Lilly's original brand name for insulin when it was introduced in the 1920s. It is the last insulin Lilly sells that is made the old-fashioned way, by mashing the pancreas glands of livestock.
Lilly is the last U.S. seller of animal insulin. It phased out its mixed beef-pork Iletin in 1998. The number of diabetics using the newly discontinued Lilly insulins amount to 2 percent of the 3.5 million insulin users in the United States. Biosynthetics began to replace animal insulins in 1983, when Humulin hit the market. Unlike animal insulins, the biosynthetics are made with human DNA and are structurally the same as insulin the body produces. Over the past six years, a handful of animal insulin activists have called on Lilly and other large insulin producers to keep selling animal insulins. They say some animal insulin users lose the ability to sense lows in their blood sugar when they take biosynthetic insulins. That puts the patients in danger of passing out or lapsing into a coma, say the activists, who include the British consumer group Insulin Dependent Diabetes Trust. "In the medical literature there really is very little support for that notion," said Dr. John Buse, director of diabetes care at the University of North Carolina School of Medicine. Buse said he doesn't think any of the 1,000 patients in his practice use the products Lilly is dropping. "People kind of voted with their feet" and turned to newer products, he said.
The two dropped Humulin formulations were approved for U.S. sale in the mid-1980s and have lost market share to newer types of insulin, said Lemons of Lilly. She said the four dropped insulins make up such a small percentage of Lilly's total insulin sales of more than $2 billion a year that "there will be no impact on manufacturing or employment." The two Humulin formulations were made at Lilly's Kentucky Avenue campus. Lilly hasn't produced Iletin recently and was selling from stockpiled inventory, she said. The discontinued products are not sold abroad, Lemons said. Once supplies of the Lilly Iletin dry up, the only way someone in the United States will be able to get animal insulin is to import it from abroad, which requires permission from the Food and Drug Administration.
Source: The Indianapolis Star
AVOIDING AMPUTATION – EARLY INTERVENTION CAN SAVE FEET
DATE: July 01, 2005
A small sore on a toe may not seem like a major medical threat. But for the millions of people who have diabetes and other conditions, it can be the first step on a road that leads to the amputation of a foot - or even a leg.
Now, a new study from the University of Michigan Cardiovascular Center may help more people save their limbs. Published in the June issue of the Annals of Surgery, it's the first-ever large study of how foot-bone infection, called osteomyelitis, is typically treated and how well the different approaches work.
Because diabetes interferes with the body's ability to heal, even the smallest foot wounds can become infected, spread to the bone, and lead to an amputation. Poor circulation and numb feet, also common in people with diabetes, make the situation worse. More than 80,000 such amputations happen each year in the United States. Experts already recommend that people with diabetes take special care of their feet and have regular foot exams to spot problems early.
The study is the first large account of the prevalence, treatment characteristics and high cost of treating osteomyelitis, which interferes with walking and sends thousands of people to the hospital each year.
On average, it shows, patients stayed in the hospital for about a week at an average cost of $19,000. Almost one in every thousand hospitalizations may be due to foot osteomyelitis, the study suggests.
"This study grew out of our own observations that many osteomyelitis patients were being treated for months or even years with antibiotics, but not healing, and this can contribute to the loss of their foot or leg," says lead author Peter Henke, M.D., an assistant professor of vascular surgery at the U-M Medical School. "But there's little evidence to guide treatment, so we wanted to look at epidemiology and outcomes. Our results show this is a common, costly issue that needs much further study."
Henke and his colleagues performed the study using data from the Nationwide Inpatient Sample, a database of hospital patient information maintained by the federal Agency on Health Care Research and Quality. They also used data from 237 osteomyelitis patients treated at the University of Michigan. Both sets of data were from patients treated between 1993 and 2000.
In all, the national data showed that 8.5 percent of patients hospitalized for foot osteomyelitis had a leg or foot amputated, and 23 percent had a toe amputated. About 1.6 percent died before leaving the hospital. Patients who were older, African American or had kidney problems were more likely to have an amputation.
Of the U-M osteomyelitis patients, 80 percent had diabetes, and 30 percent had chronic kidney problems. Nearly 40 percent also had blockage in the blood vessels of their legs, a condition called peripheral vascular occlusive disease. Nearly a quarter of the patients died within 31 months of their hospital stay.
"This is a patient population in which a non-healing foot wound becomes an ulcer, exposes the bone, and leads to osteomyelitis," says Henke.
About half of the U-M patients had been on antibiotics before being hospitalized, many of them on intravenous doses of the drugs. On average, patients had been on antibiotics for five months, and 30 percent had had more than one course of antibiotics prescribed to them before being admitted.
However, U-M patients who had been on antibiotics before they entered the hospital were much less likely to heal - perhaps because the bacteria in their infected wound had grown resistant to antibiotics.
Those who had been on antibiotics for a long time before hospitalization were also less likely to keep their limbs, possibly because the non-healing infection spread too far to allow the foot or leg to be saved. The national data did not include pre-hospital antibiotic use.
But the patients who had blood vessel reconstruction to improve circulation in their legs and feet were several times more likely to have successful wound healing and to keep their foot or leg. Toe amputees were also more likely to keep their limbs.
Patients who had clogged leg blood vessels - the condition known as peripheral vascular occlusive disease or PVOD - before their hospitalization were far less likely to keep their legs or feet over time. The patients in the study, Henke notes, were younger and more likely to have diabetes than the typical PVOD patient, but had a higher than usual risk of losing a foot or leg.
"This study suggests that antibiotics alone are not as effective as surgery plus antibiotics, both for healing wounds and saving limbs," says Henke. "It also suggests that diabetic patients, especially those with PVOD, have a very high chance of developing osteomyelitis - and that these patients should be considered for aggressive arterial reconstruction or other early intervention. This also really drives home the need for good foot care for all patients with diabetes."
Among the steps recommended for all people with diabetes are to examine their feet daily for any signs of redness, blisters, cuts or sores; to wear well-fitting shoes and protect their feet from injury; and to remove their shoes and socks at each diabetes-related checkup so feet can be examined
The researchers also find that patients whose wounds didn't heal, and those who didn't receive early surgical intervention, were much more likely to use home-health services after leaving the hospital. This kind of care, and outpatient visits, must also be considered when the costs of osteomyelitis are tallied, says Henke. But since surgery can decrease the need for outpatient visits, it may also help reduce costs of caring for a non-hospitalized osteomyelitis patient.
Because the U-M study was performed using retrospective data, the authors say a large prospective study comparing antibiotic use with surgical therapy will be needed to confirm their results before they have an impact on clinical care.
For more information, contact: Kara Gavin or Katie Gazella, U-M Health System, 734-764-2220, kegavin@umich.edu
ANTIBODY TREATMENT BOOSTS HOPE FOR TYPE 1 DIABETICS
DATE: June 24, 2005
A prototype treatment using antibodies has helped volunteers with insulin-dependent diabetes enjoy virtual independence from insulin injections, European researchers disclosed this week.
Diabetes occurs when lack of the hormone insulin causes wild fluctuations of glucose in the blood, leading to cardiovascular problems, even loss of limbs, kidney failure, blindness and death. Type 1 diabetes is the severer, inherited but rarer form of the disease - it is an auto-immune disorder, in which the body's defense system attacks insulin-making cells in the pancreas.
The test involved a manufactured monoclonal antibody, CD3, which blocks the white blood cells that are responsible for the problem. Eighty Type 1 diabetics, aged 12 to 39, were enrolled in the study. Half received the antibodies for six consecutive days, while the other half received a harmless placebo.
At an 18-month follow-up, 75 percent of those who received the antibodies enjoyed a hugely reduced dependence on insulin injections as their pancreas was able to provide the hormone naturally. "Beyond 18 months, there are grounds for believing that the degenerative complications of the disease should also be reduced," said Lucienne Chatenoud of France's National Institute for Health and Medical Research, who coordinated the research. The full study paper was published this week in the New England Journal of Medicine.
Type 1 diabetes affects about one in every 400-500 children and adolescents in the United States. Although the disease has a genetic cause, it can be amplified by nutrition and infection. Type 2 diabetes is linked to obesity and other lifestyle causes and is spreading fast among adults in more effluent countries. Type 2 diabetics do produce insulin, but at insufficient or inefficient levels - either because it is defective in some way or the cells themselves have become resistant to it.
ELI LILLY DRUG LOOKS PROMISING
DATE: June 17, 2005
An experimental Eli Lilly and Company drug to treat diabetes related problems fared well in a test on diabetic patients with kidney disease.
The compound, given the brand name Arxxant, slowed or stopped kidney damage caused by diabetes during the one-year trial.
Arxxant is in the end stage of testing. The Indianapolis drug maker hopes to file with the Food and Drug Administration later this year for approval to sell it.
The 123 patient study results were announced in San Diego earlier this week at the American Diabetes Association's annual scientific session. It is the first
time the company has shown the drug's effectiveness in treating kidney damage, which occurs in about 40 percent of people with diabetes.
"The results from this study are very encouraging," Dr. Katherine R. Tuttle, lead investigator of the study, said in a statement. "The drug may be helpful in further
slowing the progression of kidney disease," said Tuttle, a physician at Providence Medical Center in Spokane.
All patients in the study took a typical treatment for their kidney problems, plus either a sugar pill or Arxxant. Patients on the placebo experienced a significant
loss of kidney function after one year, while kidney function stayed stable in those taking Arxxant, Lilly said. No significant differences in side effects were found between the two groups. Arxxant, whose scientific name is ruboxistaurin, is a Lilly-developed pill that inhibits an enzyme thought to play a role in the damage
diabetes does to small blood vessels in the nerves, eyes and kidneys. Lilly plans to ask the FDA for approval to sell the drug for nerve damage. Approval also
may be sought to treat the kidney and eye problems, said Lilly spokeswoman Marni Lemons.
BIG ADVANCES IN STEM CELL RESEARCH CONTINUE
DATE: June 10, 2005
Scientists have made giant strides forward in the tantalizing quest to transform cells harvested from early embryos into cures for human illnesses.
Analysts hail the advances in stem cell research as magnificent, although they caution that a technical and ethical maze still lies ahead.
Any stem cell cure for damaged heart muscle, severed nerves, Alzheimer's, Parkinson's, Diabetes, and other degenerative diseases remains years away, they said.
Heading two announcements was a South Korean team, which reported in the US journal Science this past week that it had made cloned stem cells tailored to match the DNA of patients suffering from disease or spinal cord injury. They took donated human eggs and replaced the eggs' core of genetic programming with DNA from skin cells from people aged two to 56, who were suffering from spinal injuries, juvenile diabetes and an inherited form of immune deficiency. Using chemicals, the team then kicked these fused cells into life. Roughly the same principle was used to create Dolly the sheep, the world's first cloned animal, in 1996. But in this case, there was no intention at all to clone a human being. Instead, the researchers let the embryos develop for six days, long enough to develop into a cluster of the early cells that are said to develop into any of the more than 200 different types of cells in the body. <>
The idea behind stem cells is to coax them into growing into fresh tissue that can then be transplanted into the body to replace or replenish damaged cells.
But a big hurdle is to ensure that these replacement tissues are not rejected as hostile by the body's immune system.Thus the interest in cloned stem cells. As they are duplicates of the body's own DNA, they should, in theory, not encounter any rejection problem. The South Korean team, led by Seoul National University professor Woo Suk Hwang, is in the vanguard of efforts to clone stem cells. In March 2004, they became the first to carry out stem cell cloning, but they used an egg and a programming nucleus that came from the same donor, a healthy female. This time, the egg and the programming DNA are from different people, which in itself is a major step forward. Just as significant is the numbers of cloned embryos and stem cell lines, thanks to major improvements in handling the eggs and replacing their nucleus. In addition, the chromosomes of the cloned embryo and of the donor were apparently identical, which suggests that the operation had been carried out without damage to genes. And there was a reduced use of animal enzymes and serum in the chemical "bath" in which the cloned egg is placed.
From 185 donated eggs -- an enormously high number, and obtained from young volunteers -- the South Koreans were able to obtain 31 clusters of cloned cells. From these clusters, called blastocysts, 11 stem cell lines developed. This success rate "is spectacular," said Marc Peschanski, a director of research at France's medical institute Inserm. "It's enormous ... they have provided a real technological advance which is going to benefit everyone." Peschanski said the South Korean achievement destroyed a long standing objection that it is so difficult to get large numbers of cloned embryos that stem cell research is not worth pursuing.
In parallel, a team at Britain's Newcastle University also announced it had successfully produced a cloned blastocyst, although details remained sketchy and the work has yet to be published in a peer-reviewed journal. Despite the success, two big challenges remain before stem cells can ever be used as a therapy. In the lab, scientists must learn more how stem cells can be coaxed into developing into specific tissues. They must also figure out how this novel material can be transplanted without causing cancer, transferring an infectious disease or amplifying an existing one. Another is ethical, given the objections in some quarters to the use of embryonic cells and the almost universal repugnance about reproductive (as opposed to therapeutic) cloning. "If, as they claim, these South Korean scientists can reliably produce cloned embryos healthy enough to survive to the blastocyst stage for cell harvesting, we can assume that they can reliably produce embryos healthy enough to try implanting them in women," the British anti-abortion charity Life said. "This Frankenstein science should be banned in every civilized society."
The British Medical Journal (BMJ) urged a cautious approach, warning that haste, bad science and the risk of a public backlash could spell disaster for the promise of stem cells.
"Stem cell therapy needs to be nurtured safely and methodically to provide real benefit to patients in the future," it said in an editorial.
NEW STUDY SHOWS DIABETES MANAGEMENT NOT IMPROVING
DATE: June 03, 2005
A new national survey found that two thirds of people with the most common form of diabetes were failing to control their blood sugar, and most had never even heard of the best test to measure their risk of life-threatening complications.
"We have the tools to control this disease today, but diabetes management has worsened in the past 10 years, even as we're doing better as a nation with our blood pressure and cholesterol numbers," said Dr. Jaime Davidson, an associate professor of medicine at the University of Texas Southwestern Medical School who headed a recent national committee to help deliver better testing and treatment to diabetes patients. Type 2 diabetes, which accounts for 90 percent to 95 percent of all diagnosed diabetes cases, comes when the body either does not produce enough insulin or the cells ignore the insulin, the substance that takes sugar from the blood into the body's cells where it can be converted to energy. Over time, excessive amounts of sugar in the blood contribute to heart disease, stroke, nerve damage, kidney damage and blindness, among other complications.
Diabetics who monitor their blood sugar levels have tended to focus on levels obtained from blood tests before and after meals, but a more sophisticated test that measures sugar attached to red blood cells is of equal importance to diabetes specialists. Called the A1C test, it reveals a person's average blood sugar levels over the past two or three months, which tells more about how well a person is managing their condition and what their risks are for serious complications. The American Association of Clinical Endocrinologists recommends a target level of 6.5 percent for the test. Research has shown that every 1 percent increase above 6 percent elevates a diabetic's risk for serious complications. The association's survey of more than 157,000 patients in 2003 and 2004 showed that two thirds were not meeting that goal.
In-depth phone surveys with 501 patients in April found that while virtually all think it's important to control their blood sugar and 84 percent think they're doing it, 61 percent did not know what the A1C test is. Even when they were told what the test was, 51 percent said they had no idea what their score from the last screening had been. The report was released last week during the association's annual meeting. "This test is the gold standard for controlling diabetes and a risk factor all its own," said Dr. Paul Jellinger, a professor of medicine at University of Miami and co-chairman of the committee set up to implement treatment standards.
THEORY PLACES BEGINNING OF JUVENILE DIABETES AT AROUND 10,000 BC
DATE: May 27, 2005
When temperatures plummet, most people bundle up in thick sweaters, stay cozy indoors and stoke up on comfort food. But a provocative new theory suggests that thousands of years ago, juvenile diabetes may have evolved as a way to stay warm. People with the disease, also known as Type 1 diabetes, have excessive amounts of sugar, or glucose, in their blood. The theory argues that juvenile diabetes may have developed in ancestral people who lived in Northern Europe about 12,000 years ago when temperatures fell by 10 degrees Fahrenheit in just a few decades and an ice age arrived virtually overnight. <>Archaeological evidence suggests countless people froze to death, while others fled south. But Dr. Sharon Moalem, an expert in evolutionary medicine at the Mount Sinai School of Medicine in New York, believes that some people may have adapted to the extreme cold. High levels of blood glucose prevent cells and tissues from forming ice crystals, Dr. Moalem said. In other words, Type 1 diabetes would have prevented many of our ancestors from freezing to death.
The theory is described in the March 30 online edition of Medical Hypotheses, a journal devoted to publishing bold, even radical, biomedical theories that are potentially important to the development of medicine. <>Dr. Clive Gamble, a professor of geography and an expert on ancient human migration at the University of London, said the theory supported a growing body of evidence that Europeans were descended from hunters with a tolerance to cold climates and not farmers from warm ones. ''As a Brit,'' he said, ''this makes perfect sense to me.'' Dr. Robert Hegele, an expert on diabetes and genetics at the University of Western Ontario, said the theory was ''an interesting attempt to contribute a new idea to help understand the pathogenesis of Type 1 diabetes.'' But, he added, it has a major shortcoming: it fails to address the autoimmune nature of the disease. Most doctors who treat diabetes are extremely skeptical about the idea. In a typical comment, one doctor said, referring to a dangerous complication of diabetes: ''Are they kidding? Type 1 diabetes would result in severe ketoacidosis and early death.'' Not necessarily, Dr. Moalem said in an interview. Back then, life expectancy was about 25 years for many people. Those with high glucose in their blood did not live long enough to suffer complications. But they did live long enough, despite the extreme cold, to reproduce.
Today, when people live much longer, the ravages of high blood glucose are all too familiar. They include heart disease, stroke, kidney failure, high blood pressure, nerve damage, foot ulcers and gum disease. Dr. Moalem advocates using an evolutionary perspective to understand why the body is not better designed and therefore why diseases exist at all. By looking at the ancient environments in which humans evolved, he says, it should be possible to see if certain illnesses offer protective advantages. For example, some diseases have been linked to human pathogens. A disorder that leads to harmful levels of iron in the blood, hemochromatosis, protects against bubonic plague. Sickle cell anemia, a blood disorder, reduces the ability of the malaria parasite to destroy red blood cells. Cystic fibrosis combats typhoid fever. Tay-Sachs disease may have evolved to combat tuberculosis. If the theory is true, Type 1 diabetes, which strikes an estimated 29,000 young Americans each year, will be the first disease shown to have that evolved to protect people from the effects of rapid climate change.
Diabetes comes in two types: Type 1 diabetes occurs when the immune system destroys cells that produce insulin, a hormone that helps deliver glucose throughout the body; Type 2 occurs when cells throughout the body do not respond to normal amounts of insulin. Without insulin, glucose builds up into the blood. Type 2 diabetes is found all over the world, Dr. Moalem said, mostly in older overweight people. But Type 1 diabetes shows an inexplicable pattern. It is most prevalent in people descended from Northern Europeans. Finland and Sweden have extremely high rates of the disease. But it is rare in African, Asian and Hispanic populations. American Indians and Alaska Natives almost never get it unless they have significant Caucasian heritage.
Type 1 diabetes is diagnosed more often in winter than in summer. In those with the disease, blood glucose rises in colder months, regardless of diet. But in warmer climates, blood glucose does not vary with the seasons. When families with a genetic susceptibility to the disease move south to warm climates, fewer people develop diabetes. Numerous genes confer susceptibility to Type 1 diabetes, Dr. Moalem said. Risk factors are inherited from both parents. Beyond that, most experts believe that something in the environment may help set off the illness, like a virus or cold air. Cold may turn on one or more metabolic pathways involved in the genesis of Type 1 diabetes, Dr. Moalem said. In fact, many of the metabolic changes seen in Type 1 diabetes mirror those seen in animals that are tolerant to cold. <>
Dr. Kenneth Storey, a biochemist at Carleton University in Ottawa, studies the wood frog, which is found in higher latitudes throughout the Northern Hemisphere, including the Arctic Circle. ''The frog is the size of your thumb,'' he said. As soon as its skin begins to freeze in winter, its liver begins pouring glucose into its blood. This depresses the freezing point of body fluids, rather like a slushy beverage, and places a protective barrier around proteins. Eventually the frog produces so much glucose that its tissues are completely protected from the cold. It freezes solid, with no heartbeat, no circulation, no breathing, no muscle movement. In the spring, the frog thaws out and resumes normal life. Its diabetes is reversible. <>
Humans and other animals exposed to cold will first shiver to get extra heat, Dr. Moalem said. But after a while, they generate more heat by burning a special form of fat: brown adipose tissue. The ability of this tissue to produce heat depends on having a large amount of glucose. Insulin is not required. Thus, being diabetic would help shunt glucose from the blood toward the heat-making pathway of the brown adipose tissue. Mice and rats exposed to cold become insulin resistant, Dr. Moalem said. And high sugar grapes produced in cold regions, used in so-called ice wines, produce high levels of sugar to ward off freezing. Most adaptations to cold would have evolved gradually, as microbes, plants and animals learned to cope with changing climates, Dr. Moalem said. But ice cores from Greenland reveal a unique period in human history that could have forced people living in Northern Europe to adapt quickly or die. <>The climate, particularly in Europe, began to cool 14,000 years ago. About 12,600 years ago, conditions worsened. Huge drops in temperature occurred over decades. Glacial-like conditions lasted 1,300 years in a period called the Younger Dryas.
While northern Asia underwent glaciation at the same time, it does not appear to have happened with the same speed and ferocity, Dr. Moalem said, perhaps explaining why Inuits and other populations that have long histories of living in frigid climates did not develop similar protective responses to cold. Rather, they developed a different kind of defense against famine, called thrifty genes. People with such genes gain weight if they eat more than 1,000 calories a day. In today's calorie rich world, that might predispose them to Type 2 diabetes. <>People living in the frigidity of far Northern Europe could have done three things, Dr. Moalem said. They could have tried to outrun the cold, or to build better shelters and cover themselves with animal skins, or to undergo biological adaptations.
Gene mutations take a long time to accumulate, Dr. Moalem said. But so-called epigenetic factors, which change the expression patterns of genes without altering their basic structure, can produce adaptations in just a few generations.
Dr. Gamble of London said that archaeological evidence supported a large and rapid depopulation of Northern and Western Europe that coincided with the rapid cooling and the spread of thick glacial ice of the Younger Dryas. Humans huddled in Iberia, awaiting a warmer climate.
Some people appear to have ended up in Sardinia, which today has a high rate of Type 1 diabetes, Dr. Moalem said. An analysis of the Y chromosome indicates common genetic roots between modern Sardinians and ancient Northern Europeans. The idea that Type 1 diabetes is an adaptation to extreme cold needs much more research, Dr. Moalem said. Cause and effect have not been proved. But it is not too early to explore biological solutions used by cold-tolerant animals in dealing with the complications of high blood sugar. Plants and microbes adapted to extreme cold might also produce molecules that could help treat Type 1 diabetes, he said. Dr. Storey found three genes in the wood frog that turned on in response to freezing. He is now putting those genes into mammalian cells to see what happens.
Copyright ©2005 The New York Times Company
TWO PART SURGERY RETURNS ISLET CELLS AFTER REMOVAL OF THE PANCREAS
DATE: May 20, 2005
In a 12-hour, dual-stage surgery known to be performed at only two other centers in the U.S., doctors at the University of Alabama at Birmingham (UAB) returned a patient's own insulin-producing cells to him after surgically removing his pancreas to eliminate constant, severe pain from chronic pancreatitis.
The patient, a 47 year old Panama City Florida man, remained anesthetized in the operating room at UAB Hospital through removal of his entire pancreas and the hours-long wait for the pancreatic islet cells to be processed in a specialized UAB laboratory. The cells were then returned to the operating room and infused into the patient's liver, where they have begun to produce insulin. Few hospitals have the technologically sophisticated facilities necessary to isolate and purify the pancreatic islet cells either from a cadaver donor for transplantation or, as in this case, for infusion back into the same patient.
The removal of the entire pancreas is an accepted, although radical last-resort, surgery to give relief from pain, usually from inflammation of pancreatitis. In the past, such surgery might eliminate the pain but would leave the patient with severe, poorly controlled diabetes, since the insulin-producing islets of Langerhans would necessarily be discarded along with the rest of the organ. Patients without functioning islet cells have to take insulin for life. Retrieving and relocating the natural insulin-producing cells from the pancreas saves patients from the complications of severe, poorly controlled diabetes. Loss of the other major function of the pancreas, production of digestive enzymes, is dealt with by taking the enzymes as a dietary supplement.
Leading the complex operation were Drs. Selwyn M. Vickers, Devin E. Eckhoff and Juan L. Contreras. Vickers, who removed the pancreas, directs a clinic for the management of chronic pancreatitis, is chief of gastrointestinal surgery and codirector of the UAB Pancreaticobiliary Center. Eckhoff is director of the division of transplantation, and directs the university's islet cell transplant program, which uses pancreatic cells from brain-dead patients to cure insulin-dependent diabetics. Contreras is codirector of the islet transplant program. The patient was in intensive care at UAB Hospital for 2 days following the surgery, and was expected to remain in the hospital for about a week, doctors said.
The patient's chronic pancreatitis developed 4 years ago as the result of a congenitally malformed pancreatic duct that closed down following removal of his gallbladder at a Louisiana hospital. Three prior operations and several procedures to place stents in the pancreatic duct failed to provide relief. The pain of chronic pancreatitis is known to be constant and extremely debilitating. Facing a life of suffering from the condition, the patient chose the alternative of total removal of the pancreas and of autologous islet cell transplantation.
The procedure has been done previously; the first case was 16 years ago at the University of Minnesota, and the patient still survives. Only a few other cases were attempted, and results were not uniformly good, so the procedure fell out of favor until recently, when new advances in cadaveric islet cell transplantation led to more favorable outcomes.
Copyright ©2005 Diabetes Week
UNIVERSITY OF TEXAS RECEIVES GRANT TO DEVELOP INSULIN IN A PILL FORM
DATE: May 13, 2005
AUSTIN, Texas -- The National Institutes of Health has given a $2.1 million grant to a group of University of Texas researchers to find a way to create an insulin pill that would eliminate the use of injection for diabetes patients. "The insulin pill would create a less invasive and more convenient way for the millions of patients that use injections to medicate themselves," said Joan Chamberlain, a representative of NIH, a federal agency that supports medical research.
Nearly 1 million Americans are effected by Type I diabetes, which usually begins in childhood and is treated most effectively with insulin shots. Type II diabetes, often referred to as adult onset, begins later in life. Type II, a progressive form of the disease, effects nearly 17 million Americans, 30 percent of which use insulin injections once the disease has advanced. For diabetics, the new pill could make coping with the disease easier and would allow more privacy, said Joseph M. Phillips, a diabetic and a UT extension professor of American history and journalism. It would be better to not have to carry around all of the equipment needed for the injections, he said. <>The drug would also help with administering insulin to children affected by diabetes, Phillips said. "It would be a major benefit for children, because when you're young the fear of the needle is so great," he said.
Insulin functions in the bloodstream, which is why injections have been the most effective method so far, said Nicholas A. Peppas, leader of the research and a professor of chemical and biomedical engineering and pharmaceuticals. "The purpose of this research is to find a way to protect the insulin until it passes through the cells and into the blood," Peppas said. The pill would be taken orally, but a problem the researchers are trying to confront is making sure the insulin gets past the saliva, the esophagus and the stomach acids and then into the bloodstream, Peppas said. Although the pill would "make life simpler," Phillips said what he would like to see as a diabetic is something that would allow the body to function normally and produce insulin. Phillips said he hopes one day the pill will be advanced enough to only need to be taken once a day. "It would be nice to not have to announce to the world that I'm a diabetic," he said.
PIG CELL TRANSPLANT BACK FOR REVIEW IN NEW ZEALAND
DATE: May 06, 2005
In 1997, a controversial trial in which six diabetics received insulin-producing pig cells was canned, amid fears the treatment could unleash a pig virus in humans.
Eight years later, one of the trial volunteers can't wait to do it again, according to a study issued last month by the trial's medical director, Professor Bob Elliott, now medical director of Living Cell Technologies of New Zealand. A 40-year-old New Zealand man suffered no ill effects from the treatment, which was stopped on the orders of Health Ministry officials. His daily insulin dosage dropped in the first year but returned to pre-transplant levels within two years. The man insists xenotransplantation helped him control his diabetes over the next seven years, Professor Elliott says. <>Under existing law, xenotransplantation trials are allowed only with ministerial permission. New Zealand's Bioethics Council is due to make recommendations to Environment Minister Marian Hobbs in August after listening to what New Zealanders think about the controversial treatment. A council working party has just completed its first round of "dialogue" meetings focusing on cultural, spiritual and ethical issues. Their brief does not extend to safety or effectiveness.
Some people find it repugnant, others worry about the risk of animal illnesses crossing to humans, says Professor Elliott, who was at the Auckland meeting.
"There are animal rights people who feel that the use of animals is just not on and certain other individuals who have various ethnic or cultural beliefs. "My own view is that this would not be offered to the general public. This would be strictly controlled. If we do trials in New Zealand, it would be on a small number of people and we would review the results before going any further. We would follow American Food and Drug Administration guidelines, which are the best worked-out in the world, to the letter." <>Canada and Australia have adopted moratoriums. Sweden, Switzerland, Spain, the United Kingdom and United States allow some xenotransplantation under strict guidelines. China and Mexico, where pig cell transplants are available for $30,000, are less regulated. Chinese authorities have approved a trial where adrenal cells, taken from slaughterhouse cattle, are injected into cancer patients for pain relief. "They plan to do 2000 patients a day," Professor Elliott says.
Martin Wilkinson, who heads the Bioethics Council xenotransplantation working group, says it is unknown how many New Zealanders have had such transplants overseas and what, if any, risk that poses. Dubbed "xenotourism", it is understood New Zealand's first stem cell transplant recipient, Willie Terpstra, is among them. "That was also a xenotransplantation. It counts because, though it was human cells taken from an aborted fetus, it had to be grown on mouse cells. "Even if xenotransplantation was stopped in New Zealand, would you have to adopt draconian measures such as compulsory quarantine or make people own up at the border?" <>The process offers potential treatment for diabetes and Parkinson's Disease and an alternative to human donated organs, which are in short supply. Animal organs could be a solution if we could prevent rejection. Other forms of xenotransplantation involve cells or external means. "If you've got acute liver failure, what's been tried experimentally is taking blood from people with liver failure and putting it through a chamber containing pig cells, which works like dialysis, acting as a kind of bridge till they get a (human) liver transplant," Dr Wilkinson says.
Pigs are the "favored" donor animal but they carry a virus in their dna, Dr Wilkinson says. "It's part of their genes, meaning you can't avoid having it by bringing them up carefully. There were concerns it could create a new and horrible type of virus in humans. But there's enormous controversy about the likelihood of that. Some people say it's of the order of being hit by a large asteroid. Others say the risk might be low but it's a risk of a very, very bad thing happening."
Islam and Judaism forbid eating pork but some accept xenotransplantation on the basis that humans have a higher status than animals so animals can be used to improve our welfare. "Muslim views regarding a pig heart or brain, they're against that but if you talk about heart cells or brain cells, they're not so worried. The cells are somehow easier to accept," Professor Elliott says. <>The Bioethics Council "dialogue" groups meet again next month to revisit these issues. The council has an open mind, Dr Wilkinson says. "One thing that I am surprised about is the lack of people saying, `Ooh yuck, I can't allow that, it's just horrible.' From my point of view, that's good. What we're getting are reasons as opposed to gut reactions.
INHALED INSULIN APPEARS SUCCESSFUL IN EUROPEAN TRIALS
DATE: April 29, 2005
Diabetics in Europe could soon be using inhaled insulin rather than injections as test results show it is safe and effective in controlling blood sugar levels, a British diabetic charity announced last week. Drug makers Pfizer and Sanofi Aventis have already applied for licenses to market inhaled insulin throughout Europe as well as the United States, Pfizer said. A spokeswoman for the Diabetes UK charity said the medicine could be available throughout Europe in a year or two.
Test results announced at the Diabetes UK annual conference in Glasgow showed that for people with Type 2 diabetes already on tablets, inhaled insulin gave better blood glucose control than taking more tablets as treatment. Among patients with Type 1 diabetes, four years of inhaled insulin treatment combined with a daily long-lasting insulin injection was shown to be effective with no serious side effects. Anthony Barnett, professor of medicine at the University of Birmingham who has been involved in the research, said: "Our hope is that inhaled insulin will provide more choice, making it easier for people with diabetes to stay healthy." Douglas Smallwood, chief executive of Diabetes UK, said that "since insulin was discovered in the 1920s injections have been the only option. That can be difficult for some people. "Many attempts have been made to come up with new treatments and at last we appear to be close to success," he said. "While it will not be suitable for everyone this could make a real difference to the daily lives of many people with diabetes," he added.
Pfizer and Sanofi-Aventis Group are seeking approval to market Exubera, their brand of inhaled insulin powder, from both the European Medicines Evaluation Agency as well as from the US Food and Drug Administration, Pfizer said. Pfizer said Exubera is being developed for patients with Type 1 and Type 2 diabetes through a collaboration between Pfizer and Sanofi-Aventis. The two companies have entered into a global agreement to jointly develop, promote, and where permitted by law, jointly manufacture inhaled insulin, it was reveled in a statement published last month. Pfizer said Exubera, a dry powder form of insulin that is inhaled into the lungs prior to eating, using a specially designed inhalation device, has been studied in more than 3,500 patients, some for over seven years.
It said it is estimated that nearly 180 million people worldwide suffer from diabetes, and the number is expected to rise to 300 million people in the next 20 years. More than half of people with diabetes remain uncontrolled or poorly controlled and are at risk for common complications such as heart disease, stroke, kidney failure, nerve damage and blindness.
LIFESCAN ALERTS USERS WORLDWIDE OF POTENTIAL PROBLEM WITH ITS BLOOD GLUCOSE METERS
DATE: April 22, 2005
LifeScan of Milpitas California, the manufacturer of blood glucose testing meters, reported that it is initiating a worldwide notification to all users of its OneTouch Ultra, InDuo and OneTouch FastTake meters that it may be possible for users to misinterpret their blood glucose results.
All three affected meter systems were originally designed to allow patients to select one of two units of measure to display their test results. This selection is typically determined by the standard used by the country in which they live.
LifeScan, a Johnson & Johnson subsidiary, found that it was possible for consumers, in the course of setting their meter’s date and time, to accidentally change the unit of measure and thereby misinterpret their blood glucose results. Very rarely, an event such as dropping a meter while in use can cause a brief power loss, which may also unexpectedly change the unit of measure and/or the code number used to program the meter to match a particular vial of test strips. In the U.S., milligrams per deciliter (mg/dL) is the standard of measure for blood glucose testing systems. In many other countrie