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.

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.