With today’s growing type 2 diabetes epidemic, there’s a need for new ways to treat the disease. Not everyone achieves good glycemic control with oral medications and some medications, like insulin, lead to weight gain. For type 2 diabetics who also suffer from obesity, any treatment that can lead to weight gain poses a problem. But there may be a new solution. The medical technology company MetaCure has developed an implantable device, known as the DIAMOND system (formerly Tantalus), which significantly reduces blood glucose levels by applying gentle electrical stimulation to the stomach during meals.
Electrical stimulation to the stomach sounds scary, right? According to Lior Teitelbaum, MetaCure’s director of business development, it’s a lot less scary than bariatric surgeries because DIAMOND doesn’t change the anatomy of the stomach nor does it interfere with normal digestion processes. It also does not interfere with a patient’s diet and daily routine since once it’s implanted, DIAMOND operates automatically without the patient feeling the stimulation. DIAMOND requires no activation on the patient’s part.
What’s particularly interesting about DIAMOND, which also induces early satiety, is that it isn’t being marketed as a weight loss device. Trial results of the DIAMOND system showed that it brought about only modest reductions in weight (4-6 kg). It caused, however, a significant improvement in glycemic and metabolic control. In patients with type 2 diabetes, there was a reduction of 1 % in HbA1c. The trial also showed a positive effect on other metabolic parameters like reduction in systolic and diastolic blood pressure, improvement in lipid profile, waist circumference reduction, and improvement in liver enzyme levels. So it became clear that DIAMOND held benefits for type 2 diabetics. According to Metacure, the DIAMOND system has shown a clean safety profile for over four years. They presented the safety profile results at The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) meeting held in San Antonio in March 2011.
I had the opportunity to speak to Lior Teitelbaum to learn more about DIAMOND and how it works.
Who is DIAMOND for?
Our device targets type 2 diabetics who have tried all combinations of oral drugs and failed at glycemic control, and for those for whom insulin is not a good solution because it causes weight gain. It is specifically beneficial for populations that are not eligible for bariatric surgery (which requires BMI of 35 or higher). Diamond has shown good results for those with a BMI of 28-35.
How and where is DIAMOND implanted?
The DIAMOND device and electrodes are implanted in a minimally-invasive (laparoscopic) procedure under general anesthesia. Electrodes are attached to the stomach and the impulse generator and charging coil are located subcutaneously in a pocket.
How does DIAMOND work?
It works by enhancing gastric muscle activity during meals. When a person eats, the stomach muscle is triggered by a nerve to contract. DIAMOND stimulates the muscle and causes a stronger (not faster or slower) contraction. The stimulation is given to the muscle during its refractory periods. This is a very important concept because DIAMOND is not a pacer. It modulates contractions without dictating a new contraction pattern.
What’s the effect of stronger contractions?
We believe that the stronger contractions influence the hormone-based dialogue between the gastric system and the brain by affecting the release of gastric hormones in response to a meal. In essence this process strengthens and speeds up the body’s natural reaction to food consumption thereby normalizing – to some extent – the metabolic process.
This sounds similar to the effect of GLP-1 drugs like Victoza.
The major difference is that GLP-1 drugs don’t work for everyone and many patients experience substantial side effects that make it hard for them to comply with the treatment.
What’s the mechanism that actually lowers blood sugar and HbA1c?
We believe it is a combination of enhancing the metabolic response accompanied by lower food consumption per meal due to an earlier satiety sensation.
Does the patient feel the DIAMOND working? The contractions?
Normally, no. If by chance the patient does feel something it’s just a tingling sensation and we adjust the parameters so that he does not continue to feel it. It’s not nauseating or painful in any way.
What kind of upkeep does DIAMOND require?
The DIAMOND has a rechargeable battery. Once implanted, DIAMOND will operate automatically and will require no activation on your part. There is a need to charge the battery, using a portable charger once a week for about 45 minutes. Charging is wireless, non-invasive and painless, and can easily be done while reading or watching TV.
How long does the battery last?
We have patients with over four years of follow up with no need of battery change. The battery should work for a minimum of five years, but with a good recharging regime can work much longer.
When the battery is exhausted does the patient need another procedure?
That may be the case if the patient wishes to continue with treatment, but it’s similar to a heart pacemaker, meaning it does not require another laparoscopic procedure. It will just require going under the skin with a local anesthetic to replace the impulse generator.
Where is DIAMOND in clinical trials and when do you expect it to be available?
The DIAMOND system has had a CE mark since 2007 for treating type 2 diabetics who are also obese. It is already commercially available in select hospitals in Germany and will be available in additional locations in the future. In parallel the DIAMOND system is undergoing positioning clinical studies in several countries in Europe and in Hong Kong. The trial in Hong Kong is a comparison study between Diamond and insulin for people with type 2 diabetes.
Karmel Allison contributed to this interview.
Jessica Apple is the editor-in-chief of ASweetLife. She writes the blog The Natural Diabetic.