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Showing posts with label Bariatric Surgery. Show all posts
Showing posts with label Bariatric Surgery. Show all posts

Tuesday, April 5, 2011

Diabetes Management: Killer Apps That Are Revolutionizing Diabetes Care

The advantages of the wireless world are finally being brought to use beyond socializing. For us diabetics, they're being used as a means of communicating critical information about our health and the status of the conditions that can be mortally devastating and an expensive burden.

Of course, nothing replaces weight loss and proper diet. But, in the meantime, communications technology can be used as a means to inform, monitor and support patients.

Indeed, health care providers and medical companies are quickly learning how to leverage emerging communication and electronic technologies to make diabetes management more efficient, reducing hospitalizations and ultimately decreasing the cost of the disease to individuals and on society.

What's more, the health care market is seeing a large influx of companies who are putting technology to use in a growing field of healthcare communications and health-record management. At a basic level, this means using technology to manage health records and share information with a patient's physician or other approved health care providers and caregivers ‒ including family members.

But, for treating diabetes patients in particular, the use of technology has been slow. When killer apps for iPhone and iPad are out in the market days after the devices are released, it is quite ironic that given the ever-changing condition of diabetes ‒ by its very nature we could benefit from up-to-the minute capabilities that technology brings ‒ diabetes management technology remained rooted in the last century. But that’s changing.

At long last, technology is coming to the rescue of diabetics, trying to make diabetes management easier. In fact, just in the past few years, there finally has been marvelous progress in diabetes care. This isn't just with insulin pumps and home blood glucose monitoring systems. The technologies available now and those at the cusp of development are really encouraging and exciting.

Wireless Technology Improves Patient Care For Marginalized CommunitiesOf my favorites is an innovative use of wireless technology will help underserved communities improve diabetes care and prevention in Tijuana. Using 3G mobile technologies, the Dulce Wireless Tijuana project helps patients in remote areas both monitor and treat their diabetic condition. The Dulce Wireless Tijuana system, announced by Qualcomm Incorporated in October last year, combines mobile applications, web applications, mobile phones, netbooks, laptops, diabetes educational content and health care worker and patient training. Service delivery is available to diabetes patients and their caregivers wirelessly through Qualcomm’s 3G technology network.
                                              
Dulce Wireless Tijuana patients now will have access to the system and technology, including primary care diabetes services and disease management programs. The project stands as an example of how wireless technology can improve patient care for marginalized communities — not just in Mexico, but throughout the world.

Goodbye Bariatric Surgery!
Then there is a matchbox-sized gadget called DIAMOND (Diabetes Improvement and Metabolic Normalization Device) ‒ a.k.a. TANTALUS™ ‒ developed by German medical device maker MetaCure. The system is implanted under the skin on the abdomen, and stimulates the stomach muscles when the patient is eating. This tricks brain into thinking more food has entered the stomach than the person has actually eaten. To deal with this supposedly large meal, the brain boosts insulin production as well as triggering the release of hormones that suppress appetite.
This means that the patient feels full much sooner than normal. A wireless charger system allows the patient to recharge the device at home by placing the charger over the abdomen for 45 minutes, once a week. The result is an improvement in blood glucose levels, which is often accompanied by weight loss, and reduction of blood pressure, waist circumference and blood lipid level. Goodbye bariatric surgery!

Over 200 patients are using the DIAMOND system to date, many of them for over two years, and many for over four years. Trials at the Medical University of Vienna showed the device reduced blood glucose levels by a quarter over three months and the DIAMOND has been shown to significantly reduce blood glucose levels and blood pressure levels. Goodbye bariatric surgery!

Diabetes Management System Could Be iTunes of Diabetes Care
A UK-based medical device company, Cellnovo develops and manufactures an innovative mobile diabetes management system. Comprised of a mobile connected micropump, mobile touchscreen controller, blood glucose meter and applications, the Cellnovo system provides intuitive operation, wireless Internet connectivity and real-time activity tracking – all industry firsts.
Cellnovo offers extensive experience gained at the world’s premier medical device and wireless companies, including Medtronic, DuPont, Novo Nordisk, Abbott, AT&T Lucent, and other industry leaders. The Cellnovo system’s advanced micropump technology enables people with diabetes to more efficiently manage their life-saving therapies while benefiting from greater personalization and portability. This mobile-connected, disease management approach to diabetes removes the burden of keeping journals and pushes information to healthcare professionals so they always have a real-time view of this information

Treating High Blood Pressure With Radio Waves
 

The Symplicity Catheter Systemdeveloped in Australia is used to perform a procedure termed renal denervation (RDN). In a straightforward endovascular procedure, similar to an angioplasty, the physician inserts the small, flexible Symplicity Catheter into the femoral artery in the upper thigh and threads it into the renal artery. Once in place within the renal artery, the device delivers low-power radio frequency (RF) energy to deactivate the surrounding renal sympathetic nerves. This, in turn, reduces hyper-activation of the sympathetic nervous system, which is often the cause of chronic hypertension. The one-time procedure aims to permanently reduce blood pressure. RDN may also allow patients to reduce or eliminate the need for lifelong antihypertensive medications.

The procedure is highly effective with 84 per cent of patients who underwent renal denervation experiencing a reduction in systolic blood pressure by more than 10 mmHg. The study also found that the therapy was safe, with no serious device or procedure-related events, no cardiovascular complications and no kidney-related complications.

Removing Pain From Diabetes Management
A quick and painless way to measure blood sugar is highly sought-after by diabetes sufferers, who currently have to prick their fingers to draw blood several times a day. Now, researchers in the US may have found a solution – a device that works by simply shining a light on skin.

An MIT team has developed an algorithm to relate blood glucose to interstitial glucose levels. “We’ve incorporated a mass-transfer model into the overall Raman spectroscopic algorithm, which allows us to seamlessly transform between blood and interstitial fluid glucose,” explains Ishan Barman, lead author of the research.Using an early version of the device, the team tested the blood-sugar levels of some human volunteers and found that the accuracy and precision of the test was just as good as conventional finger-prick tests. In addition, the new algorithm allows the test to predict impending episodes of high or low blood sugar (hyperglycemia and hypoglycemia) by extrapolating the rate of change of sugar concentration.
The vision is to create a laptop-sized device that could be kept at home or carried around. Rather than having to pierce the skin to obtain blood samples, the device measures sugar levels by simply placing a scanner against the skin. Because measurement is fast and easy, it is hoped that the device may encourage people with diabetes to check their blood sugar more often, giving them better control over their condition.

This research addresses a real problem and appears to provide an important means for improving the calibration of non-invasive sensors. It may also be helpful in the development of a so-called ‘artificial pancreas’ – where insulin can be dispensed automatically in response to sugar levels.

High-Tech Tattoo For Monitoring Blood Sugar
Another MIT team has given people with diabetes one more reason to join the tattoo craze: a special tattoo under development could help them monitor their blood sugar. The team is developing a glucose “tattoo” that could give people with diabetes a visual track of their blood sugar, and reduce the need for the painful finger pricks required for traditional monitors. The glucose tattoo ink, which would be injected under the skin, would be made from a substance that can reflect infrared light back through the skin to a watch-sized monitor that the person with diabetes wears over the ink.

By having this special ink injected under their skin, and by consistently checking the small monitor worn over it, people with diabetes can get a “real-time” feed on their glucose. They can note and take action when they see their blood sugar climbing or dropping; they don’t have to wait until they can get to a convenient place to conduct a finger prick or, worse, until they start to feel ill. The device also opens up an avenue of thought: if special ink can alert people with diabetes to dropping glucose levels, could an automatic, implanted glucose dispenser or pump be far behind?

Shed a Tear to Test Blood Sugar
On diabetes forum like TuDiabetes, diabetics are forever discussing lancet devices, painful pricks, first drop of blood, and callused fingertips. Now a team of researchers at the Arizona State University in collaboration with the Mayo Clinic is developing a new sensor that could make the lives of diabetes patients much easier. The team has come up with a sensor that would enable patients to take tear fluid from their eye to test their glucose levels. The researchers claim the tear sample would give just as accurate a reading as a blood test does.

Team members assessed how current devices were working – or failing – and how others have attempted to solve monitoring problems. They came up with a device that can be dabbed in the corner of the eye, absorbing a small amount of tear fluid like a wick that can then be used to measure glucose. Because of its potential impact on health care, the technology has drawn interest from BioAccel, an Arizona nonprofit that works to accelerate efforts to bring biomedical technologies to the marketplace.

Improving Compliance
A number of companies have developed continuing blood glucose monitoring and insulin injection products with the goal of improving compliance in diabetic patients. Today's children with diabetes also have the opportunity for better blood glucose control than any generation before.

A research study reported in Pediatric Diabetes showed that, compared to multiple daily insulin shots, children on insulin pump therapy for 12 months significantly and consistently lowered their A1C levels. In fact, insulin pump therapy has been shown to significantly decrease severe hypoglycemia in youth. Recent studies showed that adolescents and young children on insulin pump therapy had over 50 percent fewer episodes.

To encourage compliance in diabetic children, Bayer Diabetes Care recently released its Didget blood glucose monitor, which connects to the Nintendo DS and DS Lite. The meter provides children with an adventure game that rewards consistent testing with points, which can be used to unlock new game levels. The product was approved by the FDA in April.

Bioject Medical Technologies markets a needle-free injection system that is approved for delivering subcutaneous or intramuscular injections.
The system forces liquid medication through a tiny opening held against the skin, creating an ultra-fine high-pressure stream that penetrates the skin. The technology can be used for a variety of applications, including diabetes, malaria and influenza.

Echo Therapeutics has developed a wireless, transdermal glucose monitoring system for patients with diabetes. The Symphony tCGM Systemuses a skin permeation device, called Prelude, to painlessly remove the outermost layer of skin in approximately three to five seconds, allowing the transdermal biosensor to read glucose levels through the remaining layers of skin.

OrSense has developed a noninvasive continuous glucose monitor that utilizes a patented technology called Occlusion Spectroscopy. A ring-like sensor temporarily closes off (occludes) blood flow in the patient’s finger, creating new blood dynamics that generate a unique optical signal. Clinicians can analyze the signal to obtain measurements of glucose levels and other blood parameters.

Online Diabetes Resources
Then there are new computer programs that support the analysis of home blood glucose data. Insulin pens are finally the norm and diabetes sufferers are using not just more convenient and expedient methods of insulin administration ‒ they are now using more accurate methods because of technologies that provide improved measurement and monitoring. The idea of subcutaneous glucose sensors were a dream only a decade ago and now they're an everyday part of diabetes care.

Bethesda-based Telcare, a Bethesda-based company that has developed blood glucose monitoring technology that combines a glucose meter with wireless connectivity to Telcare's "cloud" server. The electronic device keeps an open two-way communication between a patients and caregivers ‒ those that are loved ones and those that are professionals such as the nurses and doctors.

Telcare monitor users can access all of their glucose data, as well as offering additional electronic logbook capabilities such as manual recording, nutrition recording, weight management, exercise regimens, medication amounts, and blood pressure statistics. Most impressive is that Telcare provides a cross-platform social community where people with diabetes and healthcare professionals can interact, share stories, discuss the diabetes technology that they use, and learn from one another.

Many diabetes-related health problems ‒ such as eye, kidney and heart disease ‒ are the result of high levels of blood glucose affecting organs over time. So doctors are encouraged that today's young diabetes patients can achieve consistent, lower blood sugar levels from an early age that can continue for a lifetime. For example, Roche makes the ACCU-CHEK® Spirit insulin pump system.

These pumps are milestones above the traditional method of treating fluctuating glucose levels. These pumps can deliver 480 basal doses of insulin each day. But here's where technology comes in: A Palm device and the ACCU-CHEK Pocket Compass software with a bolus calculator determines a patient's bolus doses and even creates pie charts and other graphs to track a patient's progress. This software application can be loaded onto smartphones.

Another company is PositiveID Corp, a growth-stage micro-cap known for their digital personal health records technology. The company unveiled its new 'iglucose' technology at the Cellular Technology Industry Association (CTIA) annual conference in Orlando, Florida last week. It is a wireless communication device for the automatic transmission of blood glucose readings from market leading, data-capable glucometers to the iglucose database.

PositiveID's iglucose technology is making great strides in the advancement of diabetes management and control by allowing patients to wirelessly track blood glucose levels. It connects to the patient's existing glucometer and, using M2M (machine-to-machine) technology, collects, records and transmits a patient's blood glucose data to the iglucose database.

From there, it can be shared automatically via text message, email or fax with family members and health care professionals in real-time. In doing so, iglucose helps eliminate the burden of keeping journals and empowering individuals with diabetes to be more engaged in the self-management of their condition.

Cure for Diabetic Neuropathy
Neuropathy is typically measured by taking skin biopsies from the foot and running a series of specialized tests that can take up to a week to complete. In many cases, this debilitating condition is not identified until serious, and irreparable, damage has already been done.

But in a profound and important breakthrough, Nathan Efron, an Australian optometrist, has discovered that the nerves affected by neuropathy are an exact match to nerves found in front of the eye, and is testing whether looking at their level of degeneration in these nerves over a period of time would match the nerve degeneration found in arms and legs.

Quick and non-invasive eye tests would deliver results in a matter of minutes. In short, the importance of Efron’s discovery lies in the fact that since the eye is a transparent structure, it is the only place in the body where you can look directly at nerves and their degeneration over time.

There are multiple benefits of being able to measure the onset of neuropathy, one being that there are drugs in development that aim to cure diabetic neuropathy. When these drugs are ready to come onto the market the method would be able to detect nerve degeneration early and then hopefully cure it.

For the tests, patients would receive a drop of anesthetic in the eye. A corneal confocal microscope would then capture a 20 second “movie” of their eye for analysis. Two more eye tests will look at the effect of nerve degeneration on the retina.

Efron hopes his discoveries will lead to early testing for diabetic neuropathy that will motivate sufferers to better manage their disease. Testing could be carried out at the same time as diabetes patients are tested for other eye problems caused by the disease. The test has been used to monitor nerve regeneration in patients who have undergone kidney and pancreas transplants, and it could help track the effects of new treatments.

It’s interesting to ponder how technology – much of which already exist for other uses – can help us maybe not cure diseases like diabetes, but at least treat them in a way that takes the burden off the patient. There's more to come…What ideas do you have?

With inputs from Huffington Post

Wednesday, March 30, 2011

Diabetes: Implantable Gastric Stimulator May Make Bariatric Surgery Redundant

The DIAMOND System

DIABESITY is the term used to describe the combination of the diabetes and obesity epidemics taking hold across the world and those whose goal it is to prevent even more people developing these conditions state the scale of the problem in no uncertain terms.The word aptly illustrates the close association between weight and diabetes (97 per cent of all cases of Type 2 diabetes are caused by excessive weight) and is a concrete example of the wider cluster of symptoms of a metabolic disorder known as Insulin Resistance Syndrome (also called Metabolic Syndrome X).

Currently undergoing extensive trials, a pacemaker-style device that delivers mild electric pulses to the stomach could be a new way to tackle type-2 diabetes, the most common form of the disease.

The matchbox-sized gadget called DIAMOND (Diabetes Improvement and Metabolic Normalization Device) ‒ a.k.a. TANTALUS™ ‒ is implanted under the skin on the abdomen, stimulates the stomach muscles when the patient is eating.

Studies show this boost in muscle movement causes more insulin ‒ the hormone is responsible for removing excess sugar in the blood ‒ to be released.

Gastric stimulation is based on the fact that electric signals applied to a cell in a certain specific time-period called the refractory period, can modify the cell’s biochemistry and in turn, lead to a change in its behavior.

This tricks brain into thinking more food has entered the stomach than the person has actually eaten. To deal with this supposedly large meal, the brain boosts insulin production as well as triggering the release of hormones that suppress appetite.

This means that the patient feels full much sooner than normal. A wireless charger system allows the patient to recharge the device at home by placing the charger over the abdomen for 45 minutes, once a week.

The result is an improvement in blood glucose levels, which is often accompanied by weight loss, and reduction of blood pressure, waist circumference and blood lipid level.

Recently performed studies have shown that stimulation of the stomach using the DIAMOND system implant can induce satiety and can trigger signaling to the brain, affecting glucose and fatty acid metabolism.

Developed by the Dusseldorf (Germany)-based medical device company MetaCure, DIAMOND is recommended for obese Type 2 Diabetes patients who do not succeed in reducing their HbA1c level below 7 per cent, despite treatment with several oral agents.

Currently, though doctors are prescribing multiple drugs for the majority of patients (called ‘polypharmacy’), it is ineffective in controlling blood sugar in only about two thirds of patients.

Basically, DIAMOND is an advanced minimally invasive implantable electrical stimulator used to apply gastric stimulation. Using innovative technology, the device works by enhancing the activity of the gastric muscles only when the patient eats.

The device automatically senses when a patient is eating, by detecting when the stomach starts to naturally contract, and fires small painless electrical signals into the muscles of the stomach.

DIAMOND is connected by small electrodes to the patient’s stomach. It uses them to automatically sense when the patient is eating, and to send gentle signals to the stomach muscles (and through them to the brain) which enhance the normal satiety feeling.

The DIAMOND system does all this on its own, and the patient does not even feel it working, the manufacturer claims. The rate of the stimulation is dictated by the patient’s natural gastric activity, this makes treatment using the DIAMOND system personalized to each patient’s specific eating habits and physiology, without causing anatomical changes, and without hassle to the patient.

Using a wireless home-based charger system the patient can recharge the Implantable Pulse Generator (IPG) unit simply by placing it over the abdomen for 45 minutes, once a week.

Charging the device assures it has enough energy to provide treatment for years, and minimizes the need for battery replacement. The portable programmer allows medical personnel to adjust the DIAMOND signal parameters according to individual patient needs.

The DIAMOND IPG and electrodes are implanted in a minimally-invasive (laparoscopic) procedure under general anesthesia. The laparoscopic approach ‒ widely used surgical technique used for various procedures such as cholecystectomy ‒ allows for a rapid recovery with minimal discomfort. Patients implanted with DIAMOND are typically able to start eating a few hours after surgery. Hospital stay is usually 1 to 2 days.

The device does not put the patient at risk for hypoglycemia and helps to control your blood sugar levels without the need of adding medications. And unlike bariatric surgery, the procedure does not alter the patient’s physiology, and is completely reversible, allowing the device to be turned off or removed at any point.

Patients living with the DIAMOND system are not limited in their diet and can maintain an active lifestyle (not including contact sports or activities which could damage the implanted system). Maintaining a healthy and balanced diet contributes to the success of the treatment.

The DIAMOND system delivers a gentle stimulation to the stomach during meals. The stimulation corresponds with the body’s natural gastric physiology and rhythm, is safe, and has minimal effect on the patient’s anatomy.

Once implanted, DIAMOND operates automatically requires no activation. There is a need to charge the battery using a portable charger once a week for about 45 min. Charging is wireless, non-invasive and painless, and can easily be done while reading or watching TV.

Over 200 patients are using the DIAMOND system to date, many of them for over two years, and many for over four years. Trials at the Medical University of Vienna showed the device reduced blood glucose levels by a quarter over three months and the DIAMOND has been shown to significantly reduce blood glucose levels and blood pressure levels.

Researchers say small-scale studies also show improvements in blood pressure and cholesterol levels, as well as an average weight reduction of up to 5 kg over a year. Several large-scale trials are now underway in Europe and the U.S. (At the moment, DIAMOND is not available for sale in the USA.)

The DIAMOND system is the first CE-approved (European standard) implanted device for treating Type 2 Diabetes and obesity since 2007. It is currently the only active device that selectively exerts its treatment at the correct physiological context – after meals, and is approved to treat diabetes for periods longer than 12 months.

MetaCure Claims DIAMOND is better that surgical intervention, which is constantly gaining recognition as a treatment for diabetes, with 78 per cent of patients showing resolution of their diabetes post-surgery, and sustaining this status for at least two years. (See my blogpost ‘IDF Endorses Early Bariatric Surgery’ here.)

However, when looking deeper into types of surgery, it seems that reversible “lap-band” procedures are significantly less effective than the more serious gastric bypass surgeries which are irreversible and come with a significant risk to the patient. Till recently, these procedures were prescribed only to the seriously obese patients but now there’s abig push to include patients with a BMI as low as 26.

Besides, despite availability of several classes of pharmacological anti-diabetic agents there is still a clear unmet need for a safe treatment that would comprehensively address the entire metabolic syndrome and will bring about weight loss with minimal requirement for patient compliance.

In the event, DIAMOND presents a significant step forward ‒ on the one hand it is very effective in both weight reduction as well as controlling blood sugar levels (maintaining both the weight and blood sugar effects for long follow-up periods), while on the other hand it is implanted in a minimally invasive, fully reversible implantation procedure – exactly the solution required for the moderate BMI population!

IDF Endorses Early Bariatric Surgery

Return on Investment Make Gastric Bypass Cost-Effective, Claims Position Statement Issued at 2nd World Congress on Interventional Therapies for Type 2 Diabetes


The International Diabetes Federation (IDF) has issued a "radical statement" at an international conference today saying gastric banding and similar surgeries should no longer be a last resort for severely obese people with type 2 diabetes, it is recommending that surgery be considered at a much earlier stage.

"The statement highlights that there is increasing evidence that the health of obese people with type 2 diabetes, including their glucose control and other obesity related comorbidities (conditions), can benefit substantially from bariatric surgery under certain circumstances," says the IDF press release.

The IDF says gastric banding and other surgeries to alter stomach anatomy should now be considered much earlier in the treatment of type 2 diabetes.
Gastric bypass surgery works by reducing the size of the stomach so a person can't eat as much and shortening the length of the intestine so that the body doesn't absorb too many calories. But it might also have the side effect of normalizing blood sugar.

Summary of the 39-Page Statement
• Obesity and type 2 diabetes are serious chronic diseases associated with complex metabolic dysfunctions that increase the risk for morbidity and mortality.
• The dramatic rise in the prevalence of obesity and diabetes has become a major global public health issue and demands urgent attention from governments, health care systems and the medical community.
• Continuing population-based efforts are essential to prevent the onset of obesity and type 2 diabetes. At the same time, effective treatment must also be available for people who have developed type 2 diabetes
• Faced with the escalating global diabetes crisis, health care providers require as potent an armamentarium of therapeutic interventions as possible.
• In addition to behavioral and medical approaches, various types of surgery on the gastrointestinal tract, originally developed to treat morbid obesity (“bariatric surgery”), constitute powerful options to ameliorate diabetes in severely obese patients, often normalizing blood glucose levels, reducing or avoiding the need for medications and providing a potentially cost-effective approach to treating the disease.
• Bariatric surgery is an appropriate treatment for people with type 2 diabetes and obesity not achieving recommended treatment targets with medical therapies, especially when there are other major co-morbidities.
• Surgery should be an accepted option in people who have type 2 diabetes and a BMI of 35 or more
• Surgery should be considered as an alternative treatment option in patients with a BMI between 30 and 35 when diabetes cannot be adequately controlled by optimal medical regimen, especially in the presence of other major cardiovascular disease risk factors.2
• In Asian, and some other ethnicities of increased risk, BMI action points may be reduced by 2.5 kg/m
• Clinically severe obesity is a complex and chronic medical condition. Societal prejudices about severe obesity, which also exist within the health care system, should not act as a barrier to the provision of clinically effective and cost-effective treatment options.
• Strategies to prioritize access to surgery may be required to ensure that the procedures are available to those most likely to benefit.
• Available evidence indicates that bariatric surgery for obese patients with type 2 diabetes is cost-effective.
• Bariatric surgery for type 2 diabetes must be performed within accepted international and national guidelines. This requires appropriate assessment for the procedure and comprehensive and ongoing multidisciplinary care, patient education, follow-up and clinical audit, as well as safe and effective surgical procedures. National guidelines for bariatric surgery in people with type 2 diabetes and a BMI of 35 or more need to be developed and promulgated.
• The morbidity and mortality associated with bariatric surgery is generally low, and similar to that of well-accepted procedures such as elective gall bladder or gall stone surgery.
• Bariatric surgery in severely obese patients with type 2 diabetes has a range of health benefits, including a reduction in all-cause mortality.
• A national registry of persons who have undergone bariatric surgery should be established in order to ensure quality patient care and to monitor both short and long-term outcomes. 1.17 In order to optimize the future use of bariatric surgery as a therapeutic modality for type 2 diabetes further research is required.
Although such operations cost anywhere from $20,000 to $30,000, they will reduce healthcare expenditures in the long run, according to a new IDF position paper on the subject. The surgery, the IDF explains, often normalizes blood glucose levels and reduces or avoids the need for medication.

In addition, curbing diabetes can stave off costly complications such as blindness, limb amputations, and dialysis, says Francesco Rubino, MD, director of the IDF's 2nd World Congress on Interventional Therapies for Type 2 Diabetes.

"When we talk about whether we can afford bariatric surgery, we have to ask what will be the cost if we don't treat the patient. Studies have shown the surgery to be cost-effective. So there is a return on investment," says Francesco Rubino, MD, director of the IDF's 2nd World Congress on Interventional Therapies for Type 2 Diabetes

The IDF puts the lifetime cost of diabetes in the United States at $172,000 for a person diagnosed at age 50 years and $305,000 at age 30 years. More than 60% of this amount is incurred in the first 10 years after diagnosis.

The new recommended indications for performing bariatric surgery on patients who are both diabetic and obese match those announced last month by the US Food and Drug Administration for expanded use of the Lap-Band Adjustable Gastric Banding System (Allergan) to treat obesity.

The IDF recommendations dovetail with Dr Rubino’s previous research on how bariatric surgery alleviates diabetes. He showed that the effect on diabetes is not entirely explained by a person’s weight loss. In fact, the gastrointestinal tract serves as an endocrine organ and a key player in the regulation of insulin secretion, body weight and appetite, which is why altering the GI tract has such profound metabolic effects.

However, the use of bariatric surgery to treat diabetes has sparked controversy in healthcare circles. Critics question the wisdom of wielding a scalpel to solve a medical problem, especially when clinicians have more drugs at their disposal to deal with diabetes.

A study published online last week in the Archives of Surgery has raised doubts about the efficacy of LAGB. Researchers following 151 patients who underwent LAGB for obesity concluded that the procedure yielded "relatively poor long-term outcomes," with nearly half the patients needing their bands removed and 60% overall requiring some kind of reoperation. The authors, who performed the surgeries in question during the mid-1990s, added a caveat: they had used an older dissection technique.

Indeed, the biggest danger is that new weight-loss options likeEndoBarrier (developed in the UK), Lap-Band, Roux-en-Y gastric bypass and sleeve gastrectomy surgery have the potential to encourage overweight people to abandon traditional diet and exercise for procedures that carry some serious risks. That should be a big worry for all diabetes educators and activists.

Wednesday, February 23, 2011

Lap-Band & Bypass Surgery Find Match in EndoBarrier

The cacophony surrounding the news that a pair of studies has found that a different, older procedure ‒ the Roux-en-Y gastric bypass procedure - is "more effective" and "no riskier" than either the Lap-Band or the “less-drastic” (sic) sleeve gastrectomy surgery, has drowned out a news of a new British implant devise that helps weight loss and lowers blood sugar levels.

It has been reported that surgeons at a British hospital have pioneered a new treatment that could remove the need for medication to treat type 2 diabetes while helping sufferers lose weight.

Medics at Southampton General Hospital have performed the first 15 implants of a new device called the EndoBarrier.

The EndoBarrier is implanted under a short general anaesthetic and performed as a day case procedure, with all 15 patients participating in the trial discharged home within hours of completion.


Use of the EndoBarrier means that food bypasses a part of the upper intestine, so the body has less time to digest it, and also allows more control over metabolic rate and potentially lower blood sugar levels. It was shown the device could achieve weight loss of over 20 per cent of total body weight.

The sleeve is also performing as well so far as the more invasive gastric band procedure in helping weight loss.

In a 12-month study, patients fitted with the EndoBarrier achieved weight loss of more than 20% (on average 3.5 stone) of their total body weight. The sleeve is also performing as well so far as the more invasive gastric band procedure in helping weight loss.

Southampton University Hospitals NHS Trust is one of three centres in the UK participating in a study to evaluate the effectiveness of the device in patients who are overweight and suffer with type 2 diabetes. The other two are Trafford General Hospital in Manchester and St Mary's Hospital, London.

Consultant general surgeons Jamie Kelly and James Byrne at Southampton are the first to complete the initial part of the project and say they are pleased with the early findings.

"Initial results among the 15 patients who have had the EndoBarrier inserted have been really encouraging and we are very excited about the potential impact of this new treatment for patients. We are already seeing the benefit to our patients with reductions in the treatment required to manage diabetes as well as significant weight loss. The weight loss so far is tracking as well as we typically see achieved with the more invasive gastric band procedure,' Bryne explained.

Kelly added: "The procedures performed in this initial study were performed on NHS patients and further evidence of the effectiveness of this treatment will hopefully ensure it will be offered to NHS patients in the future." At present EndoBarrier is available only to private paying paients.

Anyway, the biggest danger is that new weight-loss options like EndoBarrier, Lap-Band, Roux-en-Y gastric bypass and sleeve gastrectomy surgery have the potential to encourage overweight people to abandon traditional diet and exercise for procedures that carry some serious risks. That should be a big worry for all diabetes educators and activists.

Saturday, February 19, 2011

Diabetes News: Microworms That Monitor Blood Sugar; New Approach to Bariatric Surgery; Stem Cells to Cure Diabetes

It is now recognized that it is the low- and middle-income countries that face the greatest burden of diabetes. However, many governments and public health planners still remain largely unaware of the current magnitude, or, more importantly, the future potential for increases in diabetes and its serious complications in their own countries.

However, seeing the business potential of investing in diabetes research, pharmaceutical companies are now feverishly developing new drugs and technologies to cater to a booming market. Companies are now moving beyond just drug research and are pushing the frontiers of science from nanoworms that monitor blood sugar to a permanent cure for diabetes using stem cells.

In today’s post I’m highlighting three exciting developments which, if successful, spell new hope for diabetics.

Glowing Microworms to Monitor Blood Sugar

Tiny, glowing 'microworms' implanted under the skin could be used to give blood sugar readings for diabetics, or other biomedical information, say researchers at MIT and Northeastern.

Their tube-shaped microparticles, unlike existing spherical versions, won't be swept away from the initial site over time, they say. The tubes’ narrow width keeps their contents close to blood or body tissue, while their length keeps them anchored for months on end.

The nanoparticles are created by using chemical vapor deposition (CVD) to coat an aluminum oxide layer that's been etched to contain tiny pores. Then, the coated material is dissolved away, leaving a series of hollow tubes where the pores used to be.

Before that, though, another material can be added that fluoresces in the presence of a specific chemical such as glucose. This means that when the 'microworms' are injected under the skin, they form a glowing tattoo that could be used to monitor diabetic patients.

"Tight control over glucose levels can help individuals stave off the devastating side-effects of diabetes - the number-one cause of kidney failure, blindness in adults, nervous system damage, and amputations," says MIT chemical engineering professor Karen Gleason.

"In principle, this could open the way for avoiding blood tests, which need a central lab, expert nurses, extra time and extra costs. It could be done in a doctor's office, or even at home," says Professor Raoul Kopelman of the University of Michigan. "It will also avoid complications for patients with 'difficult', or 'used-up' veins, patients on blood thinners, etc."

However, he warns that there could be concerns about long-term toxicity and bio-elimination, as well as complications such as blood clots.

Minimally Invasive Approach to Bariatric Surgery

There are scores of startups offering different approaches to obesity and diabetes eager to address the $174 billion in costs related to diabetes each year.

Now, MetaModix, a Minnesota medical device company, is moving ahead with plans to develop a minimally invasive approach to bariatric surgery and better solve the problem of type 2 diabetes.

The company is “developing a cost-effective minimally invasive therapy for type 2 diabetes” that mimics “certain elements of bariatric surgery through an endoscopic procedure.”

The process would be an out-patient procedure that would last about 30 minutes, according to Kedar Belhe, the company’s chief executive officer.

Bariatric surgery often eliminates a patient’s type 2 diabetes. However, there are concerns over the procedure itself: from post-operative side effects to the long-term impact of the surgery.

Meanwhile, the U.S. Food and Drug Administration just broadened the use of Allergan’s Lap-Band device to include more patients, for example, and other approaches range from stomach stapling, embedding sensors or inserting sleeves in the body.

Stem Cell Research Seeks Permanent Cure for Diabetes

In India, which has about 50.8 million people suffering from diabetes, another start-up, Stempeutics Research, is investing in stem cell research in the hope of discovering a permanent cure for diabetes.

Stempeutics Research has received clearance from the Drug Controller General of India (DCGI) for its investigational medicinal product Stempeucel for conducting phase II clinical trials on patients with diabetes.

“Stem cell therapy aims at addressing the root cause of the disease rather than the symptoms. Our goal is to bring out stem cell based drug in the near future. We will hit the market with our first product by end of 2011.

While the initial foray of Stempeutics is in bone marrow derived mesenchymal stem cells, Stempeutics is investing heavily on its R&D to bring out some innovative products in the near future based on adult stem cells.

There will be continuous research for each disease so as to improve product development for effective therapy. Research will be conducted on effective cell number, route of transplantation,” Stempeutics Research president BN Manohar President said.

According to the procedure, 10 patients will get one particular dosage of stempeucels, another 10 will get a higher dosage and the remaining 10 will get placebo (no drugs). “It will take at least 12 to 14 months to complete the study,” said Manohar.