A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Vestibular Nerve Stimulation (VeNS), Together With a Lifestyle Modification Program, Compared to a Sham Control With a Lifestyle Modification Program, as a Means of Improving Glycemic Control in Adults With Type 2 Diabetes Mellitus
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Neurovalens Ltd.
- Enrollment
- 200
- Locations
- 15
- Primary Endpoint
- Frequency of all device related Serious Adverse Events
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
Trial Title A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS), together with a lifestyle modification program, compared to a sham control with a lifestyle modification program, as a means of improving glycemic control in adults with type 2 diabetes mellitus.
The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS), together with a lifestyle modification program, as a method of reducing HbA1c, as compared to a sham control.
Allocation: Randomized to either active device or control device usage. All subjects will receive the same lifestyle advice.
Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation Trial Participants: Those who have been diagnosed with Type 2 diabetes mellitus.
Sample Size: The aim is to recruit a total of 200 participants. Planned Trial Period: The study will last 24 weeks in total for each subject. The primary analysis will be conducted at the 24 weeks timepoint. The study in total is estimated to take about 1.5 years to complete.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- •Male or female, age ≥ 22 years and ≤ 70 years at the time of signing informed consent. (At the US sites). The non-US sites will recruit subjects aged ≥ 18 and ≤ 70 years.
- •Diagnosed with Type 2 DM ≥ 90 days prior to day of enrolment
- •HbA1c (glycated hemoglobin) ≥ 6.5 and ≤ 9.5% (48-80 mmol/mol) (both inclusive).
- •If taking medication to treat diabetes, a stable dose of no more than 3 anti-diabetic medications for at least 90 days prior to enrolment.
- •BMI ≥ 25 at non-US sites
- •Must be under care of physician for follow-up of their type 2 DM (this can be a Primary Care Physician (PCP), endocrinologist or other hospitalist).
- •Must agree to continue to participate with their routine diabetes care program.
- •Access to Wi-Fi.
Exclusion Criteria
- •Diagnosis of Type 1 diabetes mellitus
- •Diagnosis of diabetic neuropathy
- •Diagnosis of diabetic nephropathy
- •Diagnosis of retinopathy
- •Skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears. Any disorder which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol.
- •Taking beta-blockers (if previously then can enroll if off ≥ 30 days).
- •Taking insulin (if previously on insulin then should be off for ≥ 90 days prior to enrolment).
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
- •History of pancreatitis
- •History of pancreatic surgery
Outcomes
Primary Outcomes
Frequency of all device related Serious Adverse Events
Time Frame: 24 weeks
Frequency of all Device Related Serious Adverse Events (SAEs).
Change in glycated hemoglobin (HbA1c)
Time Frame: 24 weeks
Change in HbA1c levels over the course of the study
Secondary Outcomes
- Participants who achieve HbA1c targets(24 weeks)
- Change in Body weight(24 weeks)
- Reduction of HbA1c in relation to weight loss(24 weeks)
- Change in BMI(24 weeks)
- Change in waist-hip ratio (WHR)(24 weeks)
- Change in body composition (DXA scan)(24 weeks)
- Change in atherogenic index(24 weeks)
- Change in Total Cholesterol(24 weeks)
- Change in High Density Lipoprotein (HDL)(24 weeks)
- Change in Low Density Lipoprotein (LDL)(24 weeks)
- Change in Triglycerides(24 weeks)
- Change in Very-low-density lipoprotein (VLDL)(24 weeks)
- Change in pulse rate(24 weeks)
- Change in Mean arterial pressure (MAP)(24 weeks)
- Change in fasting plasma glucose(24 weeks)
- Change in 7 point Self Measured Blood Glucose (SMBG)(24 weeks)
- Change in anti-diabetic medication(24 weeks)
- Change in cardiovascular medication(24 weeks)
- Change in audit of diabetes dependent Quality of Life (QoL) score(24 weeks)
- Tolerability of treatment(24 weeks)
- Change in healthcare resource use(24 weeks)
- Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)(24 weeks)
- Change in EQ-5D-5L(24 weeks)
- Frequency of Adverse Events (AEs)(24 weeks)
- Frequency of hypoglycemic episodes(24 Weeks)
- Frequency of episodes resulting with HbA1c > 10%(24 weeks)
- Change in hearing by means of AMTAS flex device(24 weeks)