Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes

Not Applicable

Terminated

• Conditions: Type 2 Diabetes

• Registration Number: NCT02130401
• Lead Sponsor: Scion NeuroStim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-30
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-05
• Study Start: 2014-06
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Results First Submitted: 2025-03-25
• Status Verified: 2025-05
• Results First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Results First Posted: 2025-06-06
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measurement of Glycosylated Hemoglobin (A1c)	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 Outcome Measures

Name	Time	Method
Assessment of Quality of Life	after 84 days of device use	At the end of the 84 day period of device use, the patient's reports on quality of life measures will be compared with baseline values to assess any improvement.
Measurement of Lipid Panel	after 84 days of device use	At the end of treatment (84 day) period, the patient's fasting lipid panel will be taken and compared with the baseline panel to assess any difference in lipid metabolism.
Assessment of Mood	after 84 days of device use	At the end of the 84 day period of device use, the patient's reports on mood measures will be compared with baseline values to assess any improvement.
Assessment of Diabetes Related Self Care	after 84 days of device use	At the end of the 84 day period of device use, the patient's reports on diabetes related self care will be compared with baseline values to assess any improvement.
Feasibility of the Device as an Intervention for the Diabetes Population	after 84 days of device use	At the end of the 84 day period of device use, the patient will be asked to assess the device use experience and note any shortcomings, challenges or difficulties.

Trial Locations

Locations (1)

UNC Highgate Specialty Center - UNC Diabetes Care Center; 🇺🇸 Chapel Hill, North Carolina, United States