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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: TNM (thermoneuromodulation device)

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27713
      • UNC Highgate Specialty Center - UNC Diabetes Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: TNM (thermoneuromodulation 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Scion NeuroStim
• Investigators: Study Director: Lesco Rogers, MD, Scion NeuroStim

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimate): May 5, 2014

Study Record Updates

• Last Update Posted (Estimate): September 24, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; neuromodulation; caloric vestibular stimulation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: SNS-DIA-01