NeuroMetrix, Inc., a Massachusetts-based medical device company, has filed a 510(k) form with the US Food and Drug Administration for the SENSUSTM, a pain therapy device for people who suffer diabetic neuropathy. A 510(k) is a "premarket notification" of a company's intent to market a medical product. The FDA then tests the product and provides feedback to the manufacturer. Once the FDA clears the product, its maker can introduce it to the US market.
A team of neurologists has issued a new set of recommendations for the treatment of diabetic neuropathy, including drugs and other treatments that have been found to be the most effective therapies for the condition.
When people are diagnosed with diabetes, things can seem pretty overwhelming. In a short time, they have to absorb a daunting amount of information and start making significant decisions about the way they live their lives.
Michael Hamman is a 63-year-old contractor. He recalls, "I first was diagnosed with type 2 diabetes five or six years ago. I probably had elevated blood sugar well in advance of that, but I was unaware of it. I don't remember how high my blood sugar was at the time, but I think my A1C was 7.5%. My blood sugar's never really been awful. Since I started monitoring myself, my sugar readings are normally between 150 and 165. I think it was pushing 200 before I was medicated, but the medications brought it down. They started me on glyburide and I took that for a long time, and then the A1C was moving up again, so they added the metformin. The A1C now is down in the mid-sixes. They consider it controlled, not well controlled or as good as it could be, but certainly for someone my size, it's probably as good as you can get."
Of all diabetic complications, neuropathy is one of the scariest and most difficult to treat. Nerve damage in the feet, leading to numbness or pain and, in severe cases, to foot ulcers or amputations, affects up to 60 percent of diabetics, according to recent research.
In people with longstanding type 2 diabetes who are at high risk for heart attack and stroke, lowering blood sugar to near-normal levels did not delay the combined risk of diabetic damage to kidneys, eyes, or nerves, but did delay several other signs of diabetic damage, a study has found. The intensive glucose treatment was compared with standard glucose control.
Most people who have diabetes quickly learn that one of the worst side effects of the disease is pain caused by damage to the hands and feet. High blood sugar inflames nerves, leading to tingling and numbness, and often, severe pain. Researchers at the Comprehensive Pain Center at Oregon Health & Science University in Portland have learned that onset of nerve pain may have a daily rhythm, with the worst occurring late at night around 11 p.m. Their study, which they characterized as "preliminary," tracked 647 people with diabetic neuropathy. The results showed that the typical pattern for people with the condition was to experience the greatest pain from it after sunset, peaking at 8 p.m. and 11 p.m.
Even though autumn is just around the corner, many places in the country still have a couple of hot spells left. And those surprise heat waves can be bad news for people with diabetes. It’s no secret that the elderly, the obese, and people with heart disease or respiratory conditions are vulnerable to heat-related illnesses. It’s less well known, however, that people with type 1 and type 2 diabetes are more likely than non-diabetics to suffer heat stroke, heat exhaustion, and heat cramps.
Have you ever come home from work or shopping after a long day on your feet, and all you wanted in life was to sit down and put them up? When you rested your feet on an ottoman, you immediately began to relax. The physiological reason you felt so much better was the slight widening of the peripheral capillary blood vessels in your feet-the natural response of relaxation. As the vessels opened up, more blood flowed to your feet, providing nutrients and oxygen. The foot pain and fatigue started to fade as the tissues were nourished. Ahhhh!
The Insight Foot Care Scale is a unique bathroom weight scale designed to help people with diabetes check their feet every day. As most people with diabetes know, daily foot observation is an important step in managing diabetes. Neuropathy, a common complication of diabetes, can cause complete loss of sensation in the extremities, which makes it possible for minor cuts and sores to go unnoticed until they are problematic.
Bone marrow cells that the body normally uses to restore blood vessels can be cultured to stop neuropathy and restore nerve function in diabetic mice, according to researchers at Emory University in Atlanta, Georgia.
Eli Lilly and Company, Indianapolis, agreed to pay $1.4 billion and plead guilty to promoting its antipsychotic medication Zyprexa as a treatment for dementia when it was not approved for that use by the FDA, according to the Justice Department.
Are you a scientific anomaly like me? Have you or someone you know reversed the complications associated with diabetes? Did you suffer microvascular and macrovascular damage during the “growing pains” of coming to terms with having no choice but to live your life with diabetes? Then, did you turn around and find love and hope, which made you change your life? And after changing it, did you find after several years that you were healing the damage that you had incurred by your own misguided hand?
When I was growing up in the South, my mother always told me, "You are what you eat." With Americans leading the pack in obesity and type 2 diabetes, it appears that she may have been right. Years of drive-through dinners and instant breakfasts have caught up with us, making us rethink every bite that passes our lips in our quest to fight off the complications of diabetes.
Because scientists often tend to dismiss what they don't fully understand, many of them used to think that C-peptide had no physiological function. But while it's true that C-peptide does nothing to lower blood sugar, recent research is finding that it might have a role in preventing diabetes complications.
Q: Dear Diabetes Health, My 82-year-old father is a type 2 diabetic. He is in extreme pain due to an ulcer on his toe and is at risk of amputation of his foot. Here in Canada, the doctors are quick to amputate.
Our diet has changed a great deal since our days as hunter-gatherers
on the African plains. Not only do we eat more carbs and fats, but
we may also be getting far fewer of the micronutrients that were
abundant in the primitive diet.
Peripheral neuropathy (limb nerve damage) eventually afflicts fifty percent of people with diabetes; worse still, it leads to an amputation every fifty seconds world-wide. At the moment, nothing is approved in the U.S. to treat peripheral neuropathy, only to alleviate the pain that it causes. That might change soon, however.
Do you think you might have carpal tunnel syndrome? If you have diabetes, your assumption is more likely to be correct, because carpal tunnel syndrome is fifteen times more common in people with diabetes than in the general population.
Reiki is an alternative therapy in which practitioners use gestures in the air, purportedly to channel and manipulate energy from the universe. This energy then theoretically flows through their palms, healing patients by restoring order to their unbalanced vital energy.In a recent study published in Diabetes Care, however, the energy did not seem to be flowing.
INDIANAPOLIS Data from a pooled analysis of three studies suggest that in patients with pain caused by diabetic nerve damage, or diabetic peripheral neuropathy, who are treated with Cymbalta (duloxetine HCl), improvements in both average daily pain and night pain severity were associated with less pain-related sleep interference than in those patients taking sugar pill.
When it comes to your feet, it’s important to know where you stand. Foot problems are the most common reason for diabetes-related hospitalizations, and people with diabetes are up to fifteen times more likely to have a lower limb amputation than those without diabetes.
On January 15, 2007, GW Pharmaceuticals reported results achieved by Sativex, its mouth spray made from pot, in a multi-center, double-blind, randomized, placebo-controlled study of nearly 300 patients with diabetic neuropathic pain.
Diabetes Health would like your help in addressing the lack of information about women, sex, and diabetes. To that end, we've set up a survey on our website, packed with questions about how having diabetes affects your sex life and how you overcome the hurdles that diabetes raises.
Although most research about the effect of diabetes on sex has
focused on men, some studies report that women are at higher risk
for sexual dysfunction than diabetic men. It’s high time that
the woman’s side of the story was given the attention that it
A long-term study published in a recent issue of the Journal of Palliative Medicine found that Eli Lilly’s non-narcotic prescription drug Cymbalta (duloxetine HCl) is as safe and well-tolerated as current routine care that uses one or more medications for the management of pain caused by diabetic nerve damage. Study findings also show that Cymbalta did not adversely affect the progression of diabetes or many of the complications associated with the illness, such as damage to the nerves, kidneys and eyes.
Pfizer, Inc., announced on September 21, 2005,
that Lyrica (pregabalin) capsules are now
available for the management of neuropathic
pain associated with diabetic peripheral
neuropathy (DPN), postherpetic neuralgia
(PHN) and adjunctive treatment of partial
onset seizures in adults with epilepsy.
Diabetes duration and A1C remain the gold standard for determining whether you may develop retinopathy and neuropathy. However, if you are a type 1 with a weight problem, you may not be slowing down the progression to these microvascular complications.
Chronic pain is a major limiting factor in
the performance of self-care behaviors
that help minimize diabetes-related
complications. Chronic pain should be
considered when developing effective
diabetes self-care regimens.
Relief may be on the way for the estimated five million Americans suffering from diabetes-related neuropathy pain—a stabbing, shooting, burning pain that is associated with nerve damage most often in the feet and legs but which can also occur in the hands and arms.
In the United States, amputations resulting from traumatic injury or cancer declined between 1988 and 1997. However, amputations caused by circulatory problems—which include diabetes-related complications—increased by 27 percent during that period.
Q: I want you to know that I absolutely love Diabetes Health. I read it cover to cover and then send it to my mother, who does the same. I have been insulin-dependent for nearly 26 years, and my mother has an insulin-dependent cat. We savor all of the news, enjoy the editorials and laugh at the cartoons. Diabetes Health is very informative, up-to-date and readable.
A new sensory test now detects neuropathy earlier than previous methods were able to, according to two hospitals in Chicago. The Chicago Center for Diabetic Sensory Nerve Restoration Surgery Inc. and Advanced Ambulatory Surgical Center announced that the non-invasive, painless technique allows doctors to measure levels of neuropathy in its early stages.
Nerve damage from diabetic neuropathy, most commonly found in the arms and legs, may occur in the spinal cord as well, say researchers in the United Kingdom. Simon E.M. Eaton, MRCP, of the Royal Hallamshire Hospital in Sheffield, and colleagues found that nerve damage was found in the spines of patients with diabetes. Results of the study were published in the July 7 issue of The Lancet.
In addition to numbness and tingling in the extremities, diabetes-induced nerve damage can also lead to problems with control of high blood pressure and cause incontinence, impotence, chronic diarrhea and constipation. This kind of autonomic neuropathy occurs when the branching extensions of nerve cells swell and block normal communication between the cells.
Diabetic peripheral neuropathy can make the feet numb and reduce sensitivity to pain. Without the ability to feel pain, a person may not know when and how to protect an injured area. Therefore, they just keep walking on the injured foot.
Does anyone know of an over-the-counter spray that would help neuropathy in the feet? As things go, I am using gabapentin (Neurontin) and capsaicin creams or roll-ons. I also take tramadol (Ultram) and hydrocodone for arthritis pain. None of this stuff takes the pain away completely.
Neuropathy pain has once again evaded conquer from a drug company. The latest in a series of failed drugs to reduce neuropathy pain is Alond, from Pfizer. The company recently announced that in clinical trials Alond did little more than a placebo for nerve pain in people with diabetes. Because of the disappointing results, Pfizer will go no further in bringing Alond to the Food and Drug Administration.
Lester Packer and colleagues at the University of California, Berkeley, presented research that demonstrates for the first time that free alpha-lipoic acid (ALA) is detectable in nerves, and that its level does not depend on the route of administration, but rather on the treatment dose. The study also shows that blood levels of ALA do not reflect its concentrations in nerve or other tissues. The research was presented at the American Diabetes Association's scientific sessions in June.
Electrotherapy provided pain relief to approximately 85 percent of patients with peripheral neuropathy. Peripheral neuropathy is a complication that afflicts greater than 36 percent of people with type 2 diabetes. Its symptoms include painful and burning sensations that affect the feet and ankles. Because there is a misunderstanding of peripheral neuropathy's development, several different treatment regimens have been prescribed over the years to treat the accompanying discomfort.
Only 7 percent of adult Americans and 22 percent of people with diabetes know what peripheral neuropathy is. Additionally, 15 million nondiabetic adult Americans may be suffering from peripheral neuropathy and not even know it.
Warner-Lambert is now testing a potential drug it calls Zenarestat that could prevent neuropathy. Several medications treat neuropathy pain, but according to Howard Foyt, MD, PhD, director of clinical research, diabetes and metabolic diseases for Warner-Lambert, there is none available for preventing or reducing the risk of neuropathy.
Diabetic Peripheral Neuropathy (DPN) is a condition that affects many who have diabetes. DPN has been historically difficult to treat, most commonly affects the feet and ankles, and can be severe at times.
An electrotherapy sock worn while sleeping is being hailed as the new wave of diabetes foot care. Prizm Medical Inc., manufacturers of the Silver-Thera Stocking Electrode, has enlisted top diabetes foot care researchers to verify its claim that the sock's electrotherapy relieves foot pain, improves circulation and even possibly regenerates nerves.
Patients with type 2 diabetes who suffer from neuropathy experienced relief after being treated with a combination of electrotherapy and the drug amitriptyline. The tests were conducted by Dr. Dinesh Kumar at the Los Angeles County University of Southern California Medical Center.
Neuropathy is one of the three most common complications of diabetes (along with retinopathy and kidney disease). As its name implies, neuropathy affects the nervous system. It can result in pain and/or a dangerous lack of sensation.
While all the specific causes of neuropathy are not fully understood, medical professionals and researchers agree the most effective treatment for neuropathy is the stabilization of blood glucose levels.
An estimated 1.2 million people with diabetes suffer from lower extremity ulcers each year, and of all the foot amputations in the United States, 84 percent, or 60,000 amputations, are related to diabetic foot ulcers.
The longer an individual has diabetes, the greater the probability of developing neuropathy. Neuropathy, or nerve damage, is experienced in many ways including: pain in hands and feet, trouble with digestion, loss of sensation and weak muscles.
B vitamins have been found beneficial for degenerative nerve diseases like diabetic neuropathy, according to a study published in the International Journal of Clinical Pharmacology and Therapeutics vol. 34, No. 2 - 1996 (47-50).
A little more than two months ago, I was diagnosed with carpal tunnel syndrome (CTS), a painful affliction of a nerve in the wrist-a problem that turns out to be 15 times more common in people with diabetes than in the general population. Last issue, I wrote about my early prognosis and the healing methods I had already tried. I asked people to call the DIABETES HEALTH office and tell me about their experiences with CTS. To my amazement, I received calls from dozens of readers. I found all of your stories helpful. Many of you asked me to report back about what I've learned.
Another result of the Diabetes Control and Complications Trial Research Group has been published in the April 1995 Annals of Internal Medicine. The researchers concluded that intensive diabetes therapy markedly delays or prevents the development of neuropathy, which is a disease of the nervous system.
It is well known that foot problems are among the most frequent complications of diabetes. One of the primary reasons that people with diabetes have foot problems is because of a disorder known as diabetic neuropathy.
In response to the significant number of questions and concerns we have received from our readers about neuropathy, this article attempts to offer the most up-to-date information available about what neuropathy is, what causes it, and what kinds of treatment are available. Information was gathered from a number of sources, including medical literature, interviews with physicians, and reports from you, our readers, describing your experiences.
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