Trials with over 300 patients demonstrated safety and efficacy

Efficacy1,2,3,4

  • HbA1c reduction of 1%

  • Sustained results over several years

  • Significant weight loss 5 – 10Kg

  • Reduced blood pressure by 10 mmHg

Safety1,2,5,6,7

  • Safe implantation procedure

  • Lowered risk of hypoglycemia

  • No leads dislodgement

  • Minimal side effects

DIAMOND therapy, or gastric contractility modulation (also known as gastric electrical stimulation), was validated through several clinical trials across multiple centers in seven countries, including two multi-center, randomized, double-blind controlled studies. Selected published results are presented below. For the full list of publications in peer-reviewed journals refer to the lists at the bottom of this page.

Sustained Decrease in HbA1c

Change in HbA1c in patients with type 2 diabetes with low triglyceride level managed with the DIAMOND device over three years (cross-sectional data). The decrease in HbA1c in these patients was durable over the three years and averaged at 1.1% (ANCOVA p=0.001). Reproduced from Lebovitz HE, Ludvik B, Yaniv I, 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(6):456-62. Significant decrease in HbA1c under DIAMOND therapy was also demonstrated in several additional studies.2,3,4

Sustained Weight Loss

Changes in body weight as percentage from baseline in obese type 2 diabetes patients with low triglyceride level over 12, 24 and 36 months under DIAMOND therapy. Produced from data published in Lebovitz HE, Ludvik B, Yaniv I, 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(6):456-62. Significant decrease in weight under DIAMOND therapy was also demonstrated in several other studies.2,5,6,7

DIAMOND is Equally Effective as Insulin While Avoiding Most Side Effects

Changes from baseline in a 12-month study comparing DIAMOND against insulin therapy for diabetes in obese type 2 diabetes patients. The two therapies generated a comparable drop in HbA1c levels. However, body weight, body fat, waist circumference and mean 24h systolic BP tended to decrease under DIAMOND therapy, as opposed to an increasing trend exhibited under insulin therapy. Produced from data by Wong SK, Kong AP, Luk AO, et al. A pilot study to compare meal-triggered gastric electrical stimulation and insulin treatment in Chinese obese type 2 diabetes. Diabetes Technol Ther. 2015;17(4):283-90.

References

[1] Lebovitz HE, Ludvik B, Yaniv I, 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(6):456-62.
[2] Wong SK, Kong AP, Luk AO, et al. A pilot study to compare meal-triggered gastric electrical stimulation and insulin treatment in Chinese obese type 2 diabetes. Diabetes Technol Ther. 2015;17(4):283-90.
[3] Lebovitz HE, Ludvik B, Kozakowski J, et al. Gastric electrical stimulation treatment of type 2 diabetes: effects of implantation versus meal-mediated stimulation. A randomized blinded cross-over trial. Physiol Rep. 2015;3(7).
[4] Lebovitz HE, Ludvik B, Yaniv I, et al. Fasting plasma triglycerides predict the glycaemic response to treatment of type 2 diabetes by gastric electrical stimulation. A novel lipotoxicity paradigm. Diabet Med. 2013;30(6):687-93.
[5] Bohdjalian A, Prager G, Rosak C, et al. Improvement in glycemic control in morbidly obese type 2 diabetic subjects by gastric stimulation. Obes Surg. 2009;19(9):1221-7.
[6] Sanmiguel CP, Conklin JL, Cunneen SA, et al. Gastric electrical stimulation with the TANTALUS System in obese type 2 diabetes patients: effect on weight and glycemic control. J Diabetes Sci Technol. 2009;3(4):964-70.
[7] Bohdjalian A, Prager G, Aviv R, et al. One-year experience with Tantalus: a new surgical approach to treat morbid obesity. Obes Surg. 2006;16(5):627-34.

Further Publications

  • Peles S, Petersen J, Aviv R, et al. Enhancement of antral contractions and vagal afferent signaling with synchronized electrical stimulation. Am J Physiol Gastrointest Liver Physiol. 2003;285(3):G577-85.
  • Sanmiguel CP, Aviv R, Policker S, Haddad W, Brody F, Soffer EE. Association between gastric electromechanical activity and satiation in dogs. Obesity (Silver Spring). 2007;15(12):2958-63.
  • Lebovitz HE, Gastric Contractility Modulation in the Management of Type 2 Diabetes, US Endocrine Disease: Diabetes Management, 2007, 39-41.
  • Sanmiguel CP, Haddad W, Aviv R, et al. The TANTALUS system for obesity: effect on gastric emptying of solids and ghrelin plasma levels. Obes Surg. 2007;17(11):1503-9.
  • Aviv R, Sanmiguel CP, Kliger A, et al. The use of gastric electrical signals for algorithm for automatic eating detection in dogs. Neurogastroenterol Motil. 2008;20(4):369-76.
  • Aviv R, Policker S, Brody F, et al. Circadian patterns of gastric electrical and mechanical activity in dogs. Neurogastroenterol Motil. 2008;20(1):63-8.
  • Policker S, Lu H, Haddad W, et al. Electrical stimulation of the gut for the treatment of type 2 diabetes: the role of automatic eating detection. J Diabetes Sci Technol. 2008;2(5):906-12.
  • Bohdjalian A, Ludvik B, Guerci B, et al. Improvement in glycemic control by gastric electrical stimulation (TANTALUS) in overweight subjects with type 2 diabetes. Surg Endosc. 2009;23(9):1955-60.
  • Policker S, Haddad W, Yaniv I. Treatment of type 2 diabetes using meal-triggered gastric electrical stimulation. IMAJ 2009;11(4):206-8.
  • Buchwald H. Metabolic surgery: a brief history and perspective. Surg Obes Relat Dis. 2010;6(2):221-2.
  • Buchwald H, Menchaca HJ, Michalek VN, et al. Micro-orifice metabolic/bariatric surgery under IV sedation/local anesthesia: porcine feasibility study. Obes Surg. 2010;20(4):500-5.
  • Bohdjalian A, Aviv R, Prager G, et al. Gastric stimulation in the digestive period modifies length and contractility of the inter-digestive period in obese non-diabetic and diabetic subjects. Obes Surg. 2012;22(9):1465-72.
  • Kozakowski J, Lebovitz HE, Kiciak A, Zgliczyński W, Tarnowski W. The DIAMOND system in the treatment of type 2 diabetes mellitus in an obese patient. Wideochir Inne Tech Maloinwazyjne. (Video Surgery) 2014;9(4):627-31.
  • Zonca P, Hoppe C, Cambal M, Jacobi CA. Gastric stimulation in treatment in type 2 diabetes mellitus. Bratisl Lek Listy. 2014;115(1):34-7.