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

Study Overview
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Brief Summary
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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.

Official Title
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Device: Investigational Study to Examine the Effects of Neuromodulation on Glucose Metabolism in Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: TNM (thermoneuromodulation device)


Participation Criteria
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Eligibility Criteria
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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 GLP-1 agonist (exenatide, liraglutide, exenatide LAR) SGLT-2 Inhibitors (dapaglifozin, canagliflozin) 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNM (thermoneuromodulation device)<br>A standardized active thermal neuromodulation waveform will be used for all patients. The device is non-invasive and does not use electrical stimulation. | Device: TNM (thermoneuromodulation device)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | after 84 days of device use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of lipid panel | 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. | 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. | 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. | 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. | after 84 days of device use | 
| Feasibility and acceptability 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. | after 84 days of device use | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuromodulation, caloric vestibular stimulation, Type 2 Diabetes