Background: The TANTALUS System (MetaCure Ltd.) is a minimally invasive implantable gastric stimulation modality that does not exhibit malabsorptive or restrictive characteristics. The device applies GCM (Gastric Contractility Modulation) signals to the stomach Antrum. The signals are delivered in synchronization to the native electrical activity of the stomach during meals. Retrospective analysis of previous studies indicated that T2DM subjects on oral medication with HbA1c between 7.5% and 9.5% are the population with most potential benefit from the treatment. The current study includes subjects enrolled prospectively within that range of HbA1c.
Aim: to prospectively investigate the potential effect of the TANTALUS System on glycemic control and weight in overweight subjects with T2DM.
Patients and Methods: In this European multi-center, open label study, 13 T2DM obese (6 m, 7 f, BMI: 37.1±1.0 kg/m2) subjects treated with oral anti-diabetic medications but with poor glycemic control (HbA1c 7.5-9.5%, BMI 30-45 kg/m2) were implanted laparoscopically with the TANTALUS System.
Results: Eleven subjects that have completed 3 months of treatment show a significant reduction in HbA1c from 8.0±0.2% to 7.2±0.2% (P
Session: Podium Presentation
Program Number: S087