Treatment of type 2 diabetes using meal-triggered gastric electrical stimulation.
BACKGROUND
The 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.


OBJECTIVE
To 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.


METHODS
From 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.


RESULTS
Data 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.


CONCLUSIONS
The results suggest that the TANTALUS stimulation regime can improve glucose levels and induce moderate weight loss in obese T2DM patients.
Policker
Shai
S
MetaCure (USA) Inc., Orangeburg, NY 10962, USA. shaip@metacure.com
Haddad
Walid
W
Yaniv
Irit
I
D001786:Blood Glucose / Q000378:metabolism; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000628:therapy*; D004599:Electric Stimulation Therapy / Q000295:instrumentation; D004567:Electrodes, Implanted; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007557:Israel; D008297:Male; D009765:Obesity / Q000150:complications / Q000628:therapy; D010528:Peristalsis; D019736:Prostheses and Implants; D012189:Retrospective Studies; D013270:Stomach / Q000502:physiology*; D014481:United States; D015431:Weight Loss
D001786:Blood Glucose; D006442:Glycated Hemoglobin