Device: Investigational Study to Examine the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes

Scion NeuroStim1 site in 1 country6 target enrollmentJune 2014

ConditionsType 2 Diabetes

Overview

Phase: N/A
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Scion NeuroStim
Enrollment: 6
Locations: 1
Primary Endpoint: Measurement of Glycosylated Hemoglobin (A1c)
Status: Terminated
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, proof of concept study with a single active treatment arm designed to assess whether CVS-based stimulation has a beneficial effect on patients with type 2 diabetes. The primary outcome measure is a difference between pre and post-treatment A1c.

Registry

clinicaltrials.gov

Start Date

June 2014

End Date

June 2015

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Scion NeuroStim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Measurement of Glycosylated Hemoglobin (A1c)

Time Frame: after 84 days of device use

At the end of the 84 day period of device use, the patient's A1c value will be compared with the baseline value to assess any reduction.

Secondary Outcomes

Measurement of Lipid Panel(after 84 days of device use)
Assessment of Quality of Life(after 84 days of device use)
Assessment of Mood(after 84 days of device use)
Assessment of Diabetes Related Self Care(after 84 days of device use)
Feasibility of the Device as an Intervention for the Diabetes Population(after 84 days of device use)