/ Unknown statusNot Applicable The DIAMOND® for the Treatment of Type 2 Diabetes: Can Blood Triglycerides Level be the Predictor for Therapy Efficiency A Multicentre, Prospective, Semi-randomized Study
Study to evaluate the efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c.
Relationship between blood TG level and the GCM efficacy will be evaluated.
An advanced configuration (the third generation) of the DIAMOND System for the treatment of T2DM patiënts- A randomized double blind study Ruby Study. - RUBY Study
/ CompletedNot Applicable An Advanced Configuration (The Third Generation) of the DIAMOND System for the Treatment of T2DM Patients - A Randomized, Double Blind Study
The study purpose is to demonstrate the benefit of a simplified version of the DIAMOND System (A third Generation) in comparison to a sham treatment in terms of Glycemic control, measured as A1c, FBG and Post-Prandial Glucose levels.
The study hypothesis is that HbA1c will show greater improvement in patients receiving 12 months of therapy by the DIAMOMD System than in patients not receiving this therapy.
100 Clinical Results associated with MetaCure (USA), Inc.
0 Patents (Medical) associated with MetaCure (USA), Inc.
01 Apr 2009·The Israel Medical Association journal : IMAJQ4 · MEDICINE
Treatment of type 2 diabetes using meal-triggered gastric electrical stimulation.
Q4 · MEDICINE
Article
Author: Haddad, Walid ; Yaniv, Irit ; Policker, Shai
BACKGROUNDThe TANTALUS System (MetaCure Limited) is a minimally invasive implantable device for the treatment of type 2 diabetes. The system detects food intake by sensing gastric electrical variations and applies electrical stimulation to the gut synchronized to natural gastric activity. The system is commercially available in Europe and Israel and is in clinical trials in the United States. It has been tested in 132 patients worldwide to date.OBJECTIVESTo re-analyze previously reported datafrom different studies. This retrospective analysis of the type 2 diabetes subpopulation analyzed the expected benefit and characterized the significance of baseline A1c in the determination of the expected clinical outcome.METHODSFrom the total cohort of 132 patients implanted with the TANTALUS device in 10 different centers in Europe and the U.S., we identified 50 subjects (27 females, 23 males) who were obese with uncontrolled T2DM on a stable regime of oral medication for 3 months prior to implant. This population had similar inclusion/exclusion criteria as well as treatment protocols and were all treated for at least 24 weeks. The analysis was based on the A1c change compared to baseline.RESULTSData after 24 weeks demonstrated a reduction in A1c in 80% of the patients with average drop in A1c of 1.1 +/- 0.1%. The average weight loss was 5.5 +/- 0.7 kg.CONCLUSIONSThe results suggest that the TANTALUS stimulation regime can improve glucose levels and induce moderate weight loss in obese T2DM patients.
100 Deals associated with MetaCure (USA), Inc.
100 Translational Medicine associated with MetaCure (USA), Inc.
