Diabetes: Implantable Gastric Stimulator May Make Bariatric Surgery Redundant

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 a big 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!

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