20070924

FDA Approves Continuous 7-Day Glucose Monitoring System

FDA Approves Continuous 7-Day Glucose Monitoring System

The U.S. Food and Drug Administration today approved a device that measures glucose levels continuously for up to seven days in people with diabetes.

While a standard fingerstick test records a person’s glucose level as a snapshot in time, the STS-7 Continuous Glucose Monitoring System (STS-7 System) measures glucose levels every five minutes throughout a seven-day period. This additional information can be used to detect trends and track patterns in glucose levels throughout the week that wouldn’t be captured by fingerstick measurements alone. However, diabetics must still rely on the fingerstick test to decide whether additional insulin is needed.

“The STS-7 System supplements standard fingerstick meters and test strips, providing diabetics ages 18 and older with a way to see trends and track patterns,” said Daniel Schultz, M.D., director of FDA’s Center for Devices and Radiological Health. “It can help detect when glucose levels drop during the overnight hours, show when glucose levels rise between meals and suggest how exercise and diet might affect glucose levels.”

The STS-7 System, manufactured by DexCom Inc. of San Diego, Calif., uses a disposable sensor placed just below the skin in the abdomen to measure the level of glucose in the fluid found in the body’s tissues (interstitial fluid). Sensor placement causes minimal discomfort and can easily be done by patients themselves. The sensor must be replaced weekly. An alarm can be programmed to sound if a patient’s glucose level reaches pre-set lows or pre-set highs.

Diabetes is caused by the body’s inability to produce or use insulin, a hormone that unlocks the cells of the body, allowing glucose (sugar) to enter and fuel them.

An estimated 20.8 million people in the United States—7 percent of the population—have diabetes. Most have type 2 diabetes, a condition in which the body does not properly use insulin. An estimated 5 percent to 10 percent of people with this chronic disease have type 1 diabetes, which results from the body's failure to produce insulin. People with type 1 diabetes must take insulin every day.

Diabetes can lead to wide fluctuations in blood sugar levels. Over time, abnormally high levels of glucose can damage the small and large blood vessels, leading to diabetic blindness, kidney disease, amputations of limbs, stroke, and heart disease.

While there is no known cure, studies have shown that patients who regularly monitor and regulate their blood glucose levels have lower incidences of complications associated with the disease.

FDA’s approval of the STS-7 System was based on results of a study conducted by DexCom of 72 patients with diabetes at five clinical sites in the United States. The study demonstrated that the STS-7 System was safe and effective for detecting trends and tracking patterns in glucose levels in adults.

A three-day version of the device, the STS Continuous Glucose Monitoring System, was approved in March 2006.

NEW GLUCOSE MONITORING SYSTEM FOR DIABETICS

FDA APPROVES NEW GLUCOSE MONITORING SYSTEM FOR DIABETICS
FDA approved a new medical device that provides physicians with continuous measures of tissue glucose levels in adults with diabetes. The product is the first of its kind.

The Continuous Glucose Monitoring System, made by MiniMed Inc., of Sylmar, Calif., records tissue glucose levels at five-minute intervals for up to three days. The information is then downloaded on a computer for review by health care professionals.

"Continuous tissue glucose monitoring is breakthrough technology that ultimately could revolutionize the care of diabetics," said FDA Commissioner Jane E. Henney, M.D. "This new system is a first step in that direction. It identifies patterns or trends in the fluctuation of a patient's glucose level above or below the desired range. That information can help the doctor make adjustments in therapy."

Diabetics currently monitor glucose by testing blood samples obtained from finger pricks several times a day. The new system is not intended to replace this standard fingerstick testing.

The continuous glucose monitoring system is currently intended for one-time or occasional testing, rather than ongoing daily use. The information collected is intended to supplement that obtained by standard fingerstick testing. Diabetics must continue to do fingerstick tests while using the system.

Glucose levels can fluctuate widely throughout the day in people with diabetes--from very high to very low. This makes it difficult to determine when it is important to do fingerstick tests. Until now, there has been no way to continuously monitor those fluctuations.

The new system, available only by prescription, consists of a replaceable glucose sensor, a monitor, and a unit with a special program for transferring data from the monitor to a computer.

The sensor, which contains a glucose-sensing mechanism, is inserted under the skin at the abdomen like a tiny needle. The sensor is connected by wire to the monitor, which is worn externally by the patient and is about the size of a pager. The sensor measures tissue glucose every five minutes and stores the data in the monitor's memory.

After up to 72 hours, the patient removes and discards the sensor. The information collected is then transferred to a computer in a doctor's office for review. The patient does not see the tissue glucose information while wearing the device because it is not displayed on the monitor. However, the doctor may review the results with the patient as part of ongoing therapy planning.

FDA based approval of the monitoring system on results of a study involving more than 7,000 glucose readings in 62 diabetic adults who were evaluated at four medical centers in the United States.

The study showed that the system could help identify glucose trends and supplement standard readings obtained with traditional blood glucose fingerstick measurements.

Diabetes mellitus is a chronic disease that affects the body's ability to produce or respond to insulin, a hormone that allows blood glucose to enter the body's cells and be used for energy. There are two main forms of diabetes mellitus: Type I, which occurs mainly in young people and is controlled by diet and daily injections of insulin, and Type II, which usually affects overweight people over 40 and can be controlled in most cases by diet alone.

The MiniMed system was approved for use based on experience in Type I patients. As a condition of approval, FDA is requiring the manufacturer to conduct post-marketing studies to assess its safety and effectiveness in people with other types of diabetes, as well as in children and non-Caucasians.

An estimated 16 million people in the United States have diabetes. While there is no known cure, studies have shown that patients who regularly monitor their blood glucose levels and work closely with their healthcare providers have fewer complications such as blindness, amputation and heart disease.

20070906

Hoodia Diet Pills - Fact Or Fiction?

A lot has been written about hoodia diet pills lately. Can taking a hoodia based supplement realy help you loose weight? Actually, yes it looks like it can.

First some background on the hoodia cactus.
Deep inside the African Kalahari desert, grows an ugly cactus called the Hoodia. It thrives in extremely high temperatures, and takes years to mature.

The San Bushmen of the Kalahari, one of the world"s oldest and most primitive tribes, had been eating the Hoodia for thousands of years, to stave off hunger during long hunting trips.

When South African scientists were routinely testing it, they discovered the plant contained a previously unknown molecule, which has since been christened P 57.

P 57 affects a part of your brain, the hypothalamus. Within that mid-brain there are nerve cells that sense glucose sugar.

When you eat, blood sugar goes up because of the food, these cells start firing and now you are full.

What the Hoodia seems to contain is a molecule that is about 10,000 times as active as glucose.

It goes to the mid-brain and actually makes those nerve cells fire as if you were full. But you have not eaten. Nor do you want to.

When the first animal trials for Hoodia were performed on rats, a species that will eat literally anything, they stopped eating completely.

When the first human clinical trial was conducted, a morbidly obese group of people were placed in a "phase 1 unit", a place as close to prison as it gets.

All the volunteers could do all day was read papers, watch television, and eat.

Half were given Hoodia, half placebo. Fifteen days later, the Hoodia group had reduced their calorie intake by 1000 a day.

It"s hard to diet when you"re hungry. Your body is telling you to eat, so you eat. This is the single biggest factor that keeps people from loosing weight. No matter how strong your will power is, you eventually break down and start eating too much again.

Hoodia tackles every weight problem by the root: it simply stops your craving for food. Do you think you could loose weight if you ate 50% less then you do now? You bet you could. I have taken hoodia supplements and they really do make you feel like not eating.

For more information about hoodia, go to:
http://diet-pills-review.speedylearning.com/

9 Vitamins & Supplements to Improve Your Memory

Does this describe you: You walk into the living room to get
something, only to get there and forget what you needed? You
often hear “Yes, you already told me about that” or maybe you
thought you told someone, but you never actually verbalized it.
Someone tells you their name and then ninety seconds later you
say, “Ok, tell me your name again.”

Perhaps you’re not as young as you used to be, you have more on
your plate to keep track of or you have a diagnosed or even
undiagnosed medical condition. Whatever the reason, you seem to
be plagued with a bad case CRS – Can’t Remember Squat. First and
foremost if you haven’t had a physical exam in a while, go see
your doctor. You’ll want to rule out anything serious that may
be causing your CRS. Barring any serious findings, you can take
some herbs, vitamins and other supplements to help regain some of
your memory. The vitamins, herbs and supplements listed below
may help.

Essential Fatty Acids, otherwise known as fish oils or EPA-DHA
are well known for their anti-inflammatory activity. Furthermore,
DHA is required for normal brain function in adults. Decreases in
brain DHA content are associated with age-related cognitive
decline, dementia, and Alzheimer"s disease.

Studies suggest that Polyphenol found in the skins of red grapes
and various other plants may protect against inflammation and
cognitive disorders.

Alpha-Lipoic Acid (ALA) is also an excellent antioxidant agent in
neurodegenerative diseases due to the fact that it can interrupt
free radical damage at several points. It has been shown to
elevate antioxidants in various brain regions and improves
memory. Further, ALA supports healthy blood glucose levels and
insulin activity.

Coenzyme Q10 is an antioxidant cofactor that has been shown to
protect the brain. In addition to being a potent free radical
scavenger, CoQ10 has proven to be effective in a wide variety of
age-related conditions.

Vitamin E is the primary antioxidant found in all tissues. Low
vitamin E levels are consistently associated with an increased
risk and occurrence of neurological diseases, including
Alzheimer’s and Parkinson’s. In a study of patients with
Alzheimer’s, treatment with 2000 IU of vitamin E per day for 2
years was beneficial in delaying the primary outcome (time to the
occurrence of death, institutionalization, loss of ability to
perform activities of daily living, and severe dementia) of
disease progression.

Ginkgo biloba extract is an approved treatment for dementia in
Germany, and it is the only nonprescription substance considered
a treatment for dementia in Canada. Ginkgo biloba is one extract
readily available. It enhances mental efficiency in elderly
patients with mild to moderate memory impairment. It is also
shown to improve cognitive function in patients with dementia, to
enhance blood flow to the brain, enhances cognitive performance
in patients with Alzheimer"s disease. Further it is said to
enhance memory in young individuals.

Adaptogenic herbs have been shown to reduce the negative effects
of stress. Due to the decreased ability to handle stress and the
increased levels of glucocorticoids associated with aging and
neurodegeneration, herbs with adaptogenic properties may be
beneficial. Ayurvedic herbs such as ashwagandha, holy basil, and
brahmi have a positive influence on stress response, mental
function, and cognition.

Carotenoids are a class of naturally occurring plant pigments
that provide the bright red, orange, and yellow colors of fruits
and vegetables. A balanced intake of mixed carotenoids, as found
in a healthy diet, provides the best protection against oxidative
damage.

Folate and vitamins B6 and B12 are needed for proper brain
function. Insufficiencies of these nutrients may result in
forgetfulness, memory loss, confusion, depression, dementia, and
mood and sensory changes. One study stated that age-related
impairment of cognitive function is likely related to vitamin
deficiencies, and is "preventable or reversible with improved
vitamins, especially vitamin B6, vitamin B12, and folate."

Additionally, scientists searching for a cure for Alzheimer"s
disease have found a potential ally in the herb sage. Checking
the writings of herbalists working four centuries ago, scientists
in England found a marked improvement in the memory capabilities
of Alzheimer’s patients who took sage oil extract. The finding
was consistent with a discovery by researchers at the
Universities" Medicinal Plant Research Center that sage protects
a key chemical destroyed in Alzheimer"s.

This list is not all inclusive and there could be a number of
other factors (environment, diet, disease) that could be the root
cause of your CRS. However, starting with a few supplements may
help you remember where you left your car keys!

The information contained in this article is for educational purposes
only and is not intended to medically diagnose, treat or cure any
disease. Consult a health care practitioner before beginning any
health care program.





About Author :

Emily Clark is editor at Lifestyle Health News and Medical Health News
where you can find the most up-to-date advice and information on
many medical, health and lifestyle topics.

Protein Principles for Diabetes

Dietary considerations can present a Hobson’s choice in diabetes. Even when the intake is nutritious, assimilating it can be another matter. Then there is the problem of progression of diabetic complications if one ends up with excess glucose or fat in the system. Excess carbohydrates in a meal, and the resulting uncontrolled blood sugar levels can be detrimental to any number of tissues, from the lens of the eye, to the neurons, small blood vessels and the kidneys. Fat is also a problem with increase incidences of atherosclerosis, large vessel disease and cardiac complications. What, then is the appropriate macronutrient for the diabetic population? Enough medical literature exists to suggest that in diabetes, proteins are probably the best bet.

Proteins are the natural choice of the body when faced with diabetes. In uncontrolled diabetes, muscle protein is broken down into amino acids to be converted into glucose by the liver. If left to fend for itself, this can create a commotion within the body. Since proteins have to supply enough energy to substitute for carbohydrates, proteins are broken down faster than they are made. The body ends up with a protein deficit, a situation with subtle, yet far-reaching effects on normal body functions. Importantly, for diabetics, a protein deficit has been shown to impair resistance to infections (Ganong WF). Replenishing the depleting protein stores is a vital requirement of all diabetic diets.

Importance of proteins in a diabetic has been well documented. The American Associations of Clinical Endocrinologists have made it clear that not much evidence exists to indicate that the patients with diabetes need to reduce their intake of dietary proteins. The AACE recommends that 10-20% of the calorie intake in diabetes should come from proteins (AACE Diabetes Guidelines). It is in fact believed that this is one nutrient that does not increase blood glucose levels in both diabetics and healthy subjects (Gannon et al).

Nutrition therapy for diabetes has progressed from prevention of obesity or weight gain to improving insulin’s effectiveness and contributing to improved metabolic control (Franz MJ). In this new role, a high protein diet (30% of total food energy) forms a very pertinent part of nutrition therapy. One of the most important causes for type II diabetes is obesity. Excess body fat raises insulin resistance and higher levels of insulin are required to bring down blood sugars as the weight increases (Ganong WF). Another problem with excess fat is the clogging of arteries with atherosclerotic plaques that is responsible for a wide range of diabetic complications. Any mechanism that reduces body fat decreases insulin resistance and improves blood glucose control. Parker et al have also shown that a high protein diet decreased abdominal and total fat mass in women with type II diabetes. Other studies by Gannon et al. and Nuttall et al have verified that blood glucose levels and glycosylated hemoglobin (a marker of long term diabetic control) reduce after 5 weeks on a diet containing 30% of the total food energy in the form of proteins and low carbohydrate content. It is speculated that a high protein diet has a favorable effect in diabetes due to the ability of proteins and amino acids to stimulate insulin release from the pancreas. Thus, a high protein diet is not only safe in diabetes, but can also be therapeutic, resulting in improved glycemic control, and decreased risk of complications related to diabetes.

The benefits of a high protein diet do not end here. Individual protein components of such a diet, when aptly chosen, can have other advantages as well. Dietary supplements containing proteins like whey and casein come highly recommended. Casein is a milk protein and has the ability to form a gel or clot in the stomach. The ability to form this clot makes it very efficient in nutrient supply. The clot is able to provide a sustained, slow release of amino acids into the blood stream, sometimes lasting for several hours (Boirie et al. 1997). A slow sustained release of nutrients matches well with the limited amount of insulin that can be produced by the pancreas in diabetes. A protein supplement containing casein can thus increase the amount of energy assimilated from every meal and, at the same time, reduce the need for pharmacological interventions to control blood sugar.

Whey proteins and caseins also contain “casokinins” and “lactokinins’, (FitzGerald) which have been found to decrease both systolic and diastolic blood pressure in hypertensive humans (Seppo). In addition, whey protein forms bioactive amine in the gut that promotes immunity. Whey protein contains an ample supply of the amino acid cysteine. Cysteine appears to enhance glutathione levels, which has been shown to have strong antioxidant properties -- antioxidants mop up free radicals that induce cell death and play a role in aging.

Thus, development of a protein supplement containing casein and whey can provide an apt high protein diet and its health benefits to individuals suffering from diabetes, obesity and hypercholesterolemia.



ABOUT PROTICA

Founded in 2001, Protica, Inc. is a nutritional research firm with offices in Lafayette Hill and Conshohocken, Pennsylvania. Protica manufactures capsulized foods, including Profect, a compact, hypoallergenic, ready-to-drink protein beverage containing zero carbohydrates and zero fat. Information on Protica is available at http://www.protica.com