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

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: TNM (thermoneuromodulation device)

• Registration Number: NCT02130401
• Lead Sponsor: Scion NeuroStim

Brief Summary

This is a pilot study with a single active treatment arm. The study is designed to assess the efficacy of a portable, non-invasive neuromodulation system for the treatment of Type 2 Diabetes. In particular, the primary outcome measure is a reduction in 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
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-09-24

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TNM (thermoneuromodulation device)	TNM (thermoneuromodulation device)	A standardized active thermal neuromodulation waveform will be used for all patients. The device is non-invasive and does not use electrical stimulation.

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 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 and acceptability 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.
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 the 84 day period of device use, 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.

Trial Locations

Locations (1)

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