title: Gastric electrical stimulation treatment of type 2 diabetes: effects of implantation versus meal-mediated stimulation. A randomized blinded cross-over trial.
abstract: Gastric electrical stimulation with the implanted DIAMOND device has been shown to improve glycemic control and decrease weight and systolic blood pressure in patients with type 2 diabetes inadequately controlled with oral antidiabetic agents. The objective of this study was to determine if device implantation alone (placebo effect) contributes to the long-term metabolic benefits of DIAMOND(®) meal-mediated gastric electrical stimulation in patients with type 2 diabetes. The study was a 48 week randomized, blinded, cross-over trial in university centers comparing glycemic improvement of DIAMOND(®) implanted patients with type 2 diabetic with no activation of the electrical stimulation (placebo) versus meal-mediated activation of the electrical signal. The endpoint was improvement in glycemic control (HbA1c) from baseline to 24 and 48 weeks. In period 1 (0-24 weeks), equal improvement in HbA1c occurred independent of whether the meal-mediated electrical stimulation was turned on or left off (HbA1c -0.80% and -0.85% [-8.8 and -9.0 mmol/mol]). The device placebo improvement proved to be transient as it was lost in period 2 (25-48 weeks). With electrical stimulation turned off, HbA1c returned toward baseline values (8.06 compared to 8.32%; 64.2 to 67.4 mmol/mol, P = 0.465). In contrast, turning the electrical stimulation on in period 2 sustained the decrease in HbA1c from baseline (-0.93%, -10.1mmol/mol, P = 0.001) observed in period 1. The results indicate that implantation of the DIAMOND device causes a transient improvement in HbA1c which is not sustained beyond 24 weeks. Meal-mediated electrical stimulation accounts for the significant improvement in HbA1c beyond 24 weeks.
authors.affiliation: State University of New York Health Science Center at Brooklyn, Brooklyn, New York hlebovitz1@hotmail.com.
authors.forename: Harold E
authors.initials: HE
authors.lastname: Lebovitz
authors.affiliation: Internal Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Ludvik
authors.affiliation: Center of Postgraduate Medical Education, Orlowski Hospital, Warsaw, Poland.
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Kozakowski
authors.affiliation: Medical Center of Postgraduate Education, Bielanski Hospital, Warsaw, Poland.
authors.forename: Wieslaw
authors.initials: W
authors.lastname: Tarnowski
authors.affiliation: MetaCure Ltd., Orangeburg, New York.
authors.forename: Mateusz
authors.initials: M
authors.lastname: Zelewski
authors.affiliation: MetaCure Ltd., Orangeburg, New York.
authors.forename: Irit
authors.initials: I
authors.lastname: Yaniv
authors.affiliation: Research Division at GCP Clinical Studies, Tel Aviv, Israel.
authors.forename: Tse'ela
authors.initials: T
authors.lastname: Schwartz
keywords: Gastric electrical stimulation; glycemic control; gut‐brain axis; hemoglobin A1c; placebo effect