Type 2 Diabetes
Conditions
Keywords
neuromodulation, caloric vestibular stimulation, Type 2 Diabetes
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.
Interventions
DEVICETNM 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.
Sponsors
Scion NeuroStim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
A subject is eligible for the study if all of the following criteria are met: * Provide written informed consent prior to enrollment. * Is male or female between 18-70 years old. * Has been diagnosed with type II diabetes for greater than 12 months. * Is currently either using lifestyle modification or taking one or two of the following oral antihyperglycemic agents and has been on stable doses for 90 days prior to screening: * metformin * DPP-4 inhibitors (sitagliptin, saxagliptin, alogliptin, linaglyptin) * Pioglitazone * Has an A l c between 7.5 - 9.0% based upon point of care testing performed at visit 1. * Currently performs self-monitoring blood glucose checks at least 3 times per week. * Able to adhere to protocol requirements.
Exclusion criteria
A subject will be excluded if any of the following criteria are met: * Has Type 1 Diabetes or Gestational Diabetes. * Is pregnant or planning to become pregnant during the course of the study. * Current use OR use in the past 6 months of sulfonylureas. * Current use OR use in the past 6 months of insulin * History of cardiovascular disease or cerebrovascular disease. * Any planned surgery during the course of the study. * Current continuous renal replacement therapy. * Current oral or injectable steroid use or use within the previous 3 months. * Previous or current treatment with deep brain stimulation. * Any previous known disease, injury, or surgical intervention involving the brain or central nervous system. * Moderate or greater hearing loss. * Presence of a cochlear implant. * Diagnosed vestibular dysfunction. * Eye surgery within the previous three months. * Any history of previous ear surgery. * Active ear infections or a perforated tympanic membrane. * Presence of a serious or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Poor enrollment | 6 |
Baseline characteristics
| Characteristic | Caloric Vestibular Stimulation (CVS) | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 6 Participants | — |
| Sex/Gender, Customized Sex/Gender was not collected | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
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
Population: Outcome data was not collected on any patient prior to the study termination.
Secondary
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
Population: Outcome data was not collected on any patient prior to the study termination.
Secondary
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
Population: Outcome data was not collected on any patient prior to the study termination.
Secondary
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
Population: Outcome data was not collected on any patient prior to the study termination.
Secondary
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
Population: 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.
Secondary
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
Population: Outcome data was not collected on any patient prior to the study termination.