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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
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.
UNC Highgate Specialty Center - UNC Diabetes Care Center
Chapel Hill, North Carolina, United States
Measurement of Glycosylated Hemoglobin (A1c)
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.
Time frame: after 84 days of device use
Measurement of Lipid Panel
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.
Time frame: after 84 days of device use
Assessment of Quality of Life
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.
Time frame: after 84 days of device use
Assessment of Mood
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.
Time frame: after 84 days of device use
Assessment of Diabetes Related Self Care
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.
Time frame: after 84 days of device use
Feasibility of the Device as an Intervention for the Diabetes Population
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.
Time frame: after 84 days of device use
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