The COMPLEMENT Study is a First In Human study that is being conducted in New Zealand to study the effects of Metabolic Neuromodulation Therapy on patients with type 2 diabetes. The trial is currently enrolling patients at six New Zealand centers, and has been approved by the New Zealand Ethics Committee, HDEC reference 14/NTA/102.
Patients aged 18-70 who have blood sugar (A1c) above 7.5% (58 mmol/mol) and are on an oral antidiabetic medicine called metformin are potential candidates for trial participation. Interested patients should contact one of the study coordinators at the six centers listed in the COMPLEMENT Study Information for Patients link below. Clinical study coordinators are available at each of the participating centers to answer common questions about the trial.
The Metabolic Neuromodulation System is not currently approved in any region and is limited to investigational use only for the COMPLEMENT study. CAUTION: INVESTIGATIONAL DEVICE, LIMITED TO INVESTIGATIONAL USE.