Trial Outcomes & Findings for Examining the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes (NCT NCT02130401)
NCT ID: NCT02130401
Last Updated: 2025-06-06
Results Overview
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.
TERMINATED
NA
6 participants
after 84 days of device use
2025-06-06
Participant Flow
Participant milestones
| Measure |
Caloric Vestibular Stimulation (CVS)
The TNM Device will provide a standardized active thermal waveform that will be used for all patients. The device is non-invasive and does not use electrical stimulation.
TNM Device: The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Caloric Vestibular Stimulation (CVS)
The TNM Device will provide a standardized active thermal waveform that will be used for all patients. The device is non-invasive and does not use electrical stimulation.
TNM Device: The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.
|
|---|---|
|
Overall Study
Poor enrollment
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Caloric Vestibular Stimulation (CVS)
n=6 Participants
The TNM Device will provide a standardized active thermal waveform that will be used for all patients. The device is non-invasive and does not use electrical stimulation.
TNM Device: The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=6 Participants
|
|
Sex/Gender, Customized
Sex/Gender was not collected
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: after 84 days of device usePopulation: Outcome data was not collected on any patient prior to the study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 84 days of device usePopulation: Outcome data was not collected on any patient prior to the study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 84 days of device usePopulation: Outcome data was not collected on any patient prior to the study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 84 days of device usePopulation: Outcome data was not collected on any patient prior to the study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 84 days of device usePopulation: Outcome data was not collected on any patient prior to the study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: after 84 days of device usePopulation: Study was halted before any of the participants could complete any of the other endpoints making it impossible to assess the feasibility of the device's use in this population. Data was not collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
Caloric Vestibular Stimulation (CVS)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place