articles link to it . please introduce links to this page from related articles ; try the find link tool for suggestions . july 2011 metacure ltd. type private industry medical devices and medical technology founded 2003 founder dr. shlomo ben haim key people dr. mateusz zelewski general manager products diamond system formerly the tantalus system website metacure ltd. website metacure is a privately held global medical device company that develops and markets minimally invasive treatments for type 2 diabetes and obesity by regulating postprandial sugar metabolism and satiety through the use of gastric electrical stimulation . 1 2 contents 1 history 2 type 2 diabetes and obesity 2.1 treatment goals 2.2 types of treatment 3 the diamond system 3.1 mechanism of action 3.2 diamond implantation 3.3 clinical data 3.4 efficacy 3.5 safety 3.6 medical uses 4 see also 5 external links 6 references history edit file novel interventions for diabetes panel wcitd sep 28 2015.jpg prof. lebovitz left presents recent clinical data on diamond at the 3rd world congress on interventional therapies for type 2 diabetes london sep 28 2015 . founded in 2003 by dr. shlomo ben haim metacure has developed an implantable medical device system for the treatment of type 2 diabetes and obesity . the company s diamond system formerly called tantalus uses a platform technology that provides non excitatory non pacing stimulation to tissue that produces a physiological response . the electrical stimulation which is applied to the stomach muscles is called gastric contractility modulation gcm . through gcm diamond improves how glucose is metabolized in the body . 1 2 3 this platform technology was first applied to the treatment of heart failure . when applied to heart tissue the electrical stimulation is known as cardiac contractility modulation . 4 metacure is one of the portfolio companies of the hobart group which invests in medical device companies . 5 type 2 diabetes and obesity edit main article diabetes mellitus type 2 the international diabetes federation estimates that diabetes affects 566 million people worldwide 6 with 90 % 95 % of people having type 2 diabetes . 7 the prevalence of diabetes is expected to increase to over 770 million in 2035 . 6 this rise in prevalence is expected to occur because of the global obesity epidemic . 8 9 obesity is a major risk factor for the onset of diabetes . 10 in fact obesity and abdominal fat is thought to account for 80 % 90 % of type 2 diabetes cases which has led to the creation of the term diabesity . 9 the world health organization who estimates that more than 60 % of adult americans and approximately half of female europeans are overweight and obese . 11 prevalence of diabetes worldwide in 2000 . world average was 28 per 1000 inhabitants . no data 7.5 7.5 15 15 22.5 22.5 30 30 37.5 37.5 45 45 52.5 52.5 60 60 67.5 67.5 75 75 82.5 82.5 treatment goals edit controlling post prandial blood glucose concentration is a primary treatment goal for type 2 diabetes . blood glucose concentration is assessed by measuring the amount of glycated hemoglobin hba1c in the blood . the uk prospective diabetes study ukpds found that a 1 % reduction in hba1c lowers the risk for diabetes related mortality by 21 % and myocardial infarction mi by 14 % . reducing hba1c by 1 % also lowers the risk of microvascular complications such as amputation of a limb which is a common complication of diabetes . 12 types of treatment edit further information diabetes management after failing dietary and lifestyle counseling most patients with diabetes are initially treated with oral medication such as metformin . as diabetes is progressive most patients will need treatment intensification to achieve hba1c targets . treatment intensification may include the addition of other oral medications insulin or another injectable treatment glucagon like peptide receptor agonists glp 1 ras . patients who are also obese may be referred for bariatric surgery . 10 anti diabetic treatments have varying degrees of effectiveness in lowering hba1c . effectiveness of any medication is also affected by a patient s treatment adherence . 13 insulin which is injected by the patient with a needle or a pen like device is most effective at lowering hba1c . 10 however insulin has two notable side effects hypoglycemia and weight gain that can be a challenge to manage and have clinical consequences . 10 the diamond system edit file diamond ii w ruler.jpg diamond ii active implantable pulse generator ipg by metacure intended for the treatment of diabetes in obese patients . the diamond system was developed to address the gaps in existing treatment options for obese patients with diabetes . it is thought that the use of gastric contractility modulation electrical stimulation of the stomach enabled by a one time minimally invasive procedure with minimal complications no dietary restrictions and negligible patient adherence requirements could address the clinical challenge of treating patients with type 2 diabetes . 14 diamond ii is a medical device system that consists of an implantable pulse generator electrodes a programmer and a patient charger . mechanism of action edit the mechanism by which diamond s gastric contractility modulation gcm improves blood glucose concentration and induces weight loss is being investigated . it is hypothesized that diamond corrects the body s natural metabolism processes by resynchronizing the timing of the gut brain liver axis activation with food intake . 2 once food leaves the stomach and enters the duodenum the gut brain liver axis is activated which involves signaling between the gastrointestinal tract and the nervous system . for patients without type 2 diabetes the gastric transit time of food is estimated to be 30 45 minutes the time from food ingestion to food leaving the stomach into the duodenum . in type 2 diabetes the neurohormonal communication system is impaired . delayed signaling within the gut brain liver axis leads to high blood glucose concentration after meals . 15 the proposed mechanism of action of diamond reproduced from lebovitz he et al. horm metab res . 2015 ; 47 456 62 . diamond uses an algorithm that allows it to automatically detect food intake . when diamond senses that food has entered the stomach energy from a rechargeable pulse generator is transmitted to electrodes attached to the gastric antrum . diamond provides non excitatory electrical stimulation which causes increased contractile force to each of the naturally occurring rhythmic stomach contractions normal stomach peristalsis . in this way diamond strengthens stomach contractions to a similar level that occurs when the normal stomach is emptying the food content into the duodenum . the stronger antral contractions activate the gut brain liver axis just as they do normally when food is entering the duodenum . 16 signals are sent from the stomach along afferent vagal nerve fibers to the hypothalamus which interprets the signals to mean that food has departed the stomach . in this way diamond induces early satiety . the hypothalamus also sends signals to the pancreas to release insulin and to suppress glucagon . signals are also sent to the liver to stop production of glucose and start using glucose to synthetize glycogen . in this way diamond resynchronizes the metabolic response to food intake and improves blood glucose levels . 2 illustration of the enhanced stomach muscle contraction elicited by gastric contractility modulation gcm ; reproduced from lebovitz h. diabetes management . touch briefings . 2007 . diamond implantation edit diamond is implanted during a minimally invasive laparoscopic procedure . the electrodes that detect food intake are attached to the surface of the gastric fundus . the electrodes that provide stimulation are attached to the gastric antrum . the pulse generator is housed in a surgically created pocket in subcutaneous tissue in the upper left area of the abdomen similar to a standard pacemaker implantation . the procedure does not entail any changes to the stomach s anatomy which means that the procedure is reversible i.e. diamond ii can be explanted . 16 17 clinical data edit the efficacy and safety of diamond has been examined in several clinical trials including two randomized controlled trials a long term study and an insulin comparative study . 2 18 19 the various clinical studies have demonstrated that diamond therapy has several metabolic benefits including blood glucose control weight loss reduction in waist circumference and blood pressure that have been sustained for a minimum of three years . 2 18 diamond also had favorable outcomes compared to insulin therapy in a randomized controlled trial . 19 the diamond procedure is safe and well tolerated according to clinical trial investigators . 17 19 efficacy edit in a multicenter open label study 24 obese patients with diabetes received laparoscopic implantation of tantalus diamond . at one year follow up diamond resulted in significant reductions in weight and hba1c p 0.05 . 17 a later analysis of 50 patients treated with oral antidiabetic medication showed that 80 % of the cohort experienced hba1c improvement with an average decline of 1.1 % at 24 weeks . the mean weight loss was 5.5 kg . 3 in an analysis of 61 diabetic patients that failed oral medication for treating their diabetes the hba1c reduction averaged 0.9 % . in patients with normal triglycerides the hba1c was reduced by 1.1 % during three years of follow up . the mean weight loss for the entire cohort was 5.7 % . weight loss of more than 10 % was experienced by a significant percentage of patients with normal triglyceride levels and maintained to three years 2 a separate randomized blinded cross over trial of 51 patients has also shown that gcm accounts for significant improvement in hba1c . 18 diamond s gcm has also been compared to insulin in 16 obese diabetic patients on oral medication who needed treatment intensification . patients were randomized to receive implantation of diamond or to an insulin treatment group . at one year follow up patients who were treated with diamond s gcm experienced an average weight loss of 3.2 kg and reduction in waist circumference of 3.8 cm . comparatively patients treated with insulin gained 1.4 kg on average . patients treated with diamond also had greater reduction in hba1c than those treated with insulin at 1.6 % and 0.6 % respectively . diamond also resulted in systolic blood pressure improvement of 4.5 mmhg whereas patients in the insulin arm had an increase of 2.3 mmhg on average . 19 safety edit the adverse event rate for implantation of the diamond ii system is similar to that for other common laparoscopic procedures such as transient post procedure abdominal pain and have been reported to be mild . 17 19 medical uses edit the diamond system first received ce mark in 2007 and is approved for sale in europe australia hong kong and other international markets . 20 diamond is currently not available for use in the united states . see also edit type 2 diabetes obesity international diabetes federation gut brain liver axis external links edit international diabetes federation diabetes atlas world health organization diabetes programme world health organization obesity references edit a b lebovitz h. gastric contractility modulation in the management of type 2 diabetes . diabetes management . touch briefings . 2007 . a b c d e f g lebovitz he ludvik b yaniv i schwartz t et al. treatment of patients with obese type 2 diabetes with tantalus diamond gastric electrical stimulation normal triglycerides predict durable effects for at least 3 years . horm metab res . 2015 ; 47 456 62 . a b policker s haddad w yaniv i. treatment of type 2 diabetes using meal triggered gastric electrical stimulation . imaj . 2009 ; 11 132 134 . borggrefe m burkhoff d. clinical effects of cardiac contractility modulation ccm as a treatment for chronic heart failure . eur