Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control as a Means of Improving Glycemic Control in Adults With Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes
- Interventions
- Device: Vestal DM Active deviceBehavioral: Lifestyle modificationDevice: Vestal DM Sham device
- Registration Number
- NCT04595968
- Lead Sponsor
- Neurovalens Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
- Hemochromatosis
- Either of the following within the previous year: myocardial infarction; or acute coronary syndrome.
- History of stroke
- History of epilepsy
- Splenectomy (due to effect on red blood cell turnover)
- History of anemia (if resolved for > 90 days with treatment then can enroll)
- Blood transfusion within 90 days of enrolment (due to effect on HbA1c). (If transfusion occurs once enrolled then subject will be withdrawn).
- A diagnosis of a hemoglobinopathy (e.g. sickle cell disease and thalassemia, although those with sickle cell or thalassemic trait would be allowed to enroll);
- If on dietary supplements or herbal remedies, then if the subject is taking a preparation that might affect glycemic control they will be excluded. Specifically, subject will be excluded if taking biotin (vitamin B7); alpha-lipoic acid; chromium; herbal preparations marketed as being for diabetes.
- History of being diagnosed with renal, heart or liver failure
- History of active migraines with aura
- History of head injury requiring intensive care or neurosurgery.
- Change in diabetic medication within the last 90 days (prior to enrolment).
- Regular use (more than twice a month) of antihistamine medication within the last 6 months. Note: If the participant is taking Fexofenadine, they can be eligible for the trial. If the participant is on another anti-histamine medication they can voluntarily opt to switch to Fexofenadine and enrol in the trial after a washout period of 2 weeks.
- Current use of H2-receptior antagonist medication? (e.g., cimetidine, famotidine)
- History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
- A diagnosis of myelofibrosis or a myelodysplastic syndrome.
- Previous use of Modius device
- Participation in other clinical trials sponsored by Neurovalens (e.g. Vestal study)
- Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.)
- Have a member of the same household who is currently participating in this study.
- History of vestibular dysfunction or other inner ear disease (as assessed on the screening questionnaire)
- Failure to pass the ATMAS Flex hearing test
- Failure to demonstrate a willingness for lifestyle modification (i.e diet and exercise) if BMI is ≥25 (as assessed on the screening questionnaire)
- Failure to agree to weekly engagements with the Clinical Trial Mentors during trial participation
- Failure to agree to use of device daily during trial participation (no more than 2 weeks usage drop without reasonable explanation)
- Use of any medication (e.g. hormonal modulators or corticosteroids) that could cause iatrogenic T2DM. (NB Topical steroid use is acceptable if judged by PI to be unrelated).
- Any other medical condition, or medication use, that in the opinion of the PI/CI is likely to make the subject refractory to VeNS.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vestal DM active device Vestal DM Active device 150 subjects randomised to receive active device plus lifestyle intervention for 24 weeks Vestal DM active device Lifestyle modification 150 subjects randomised to receive active device plus lifestyle intervention for 24 weeks Vestal DM sham device Vestal DM Sham device 150 subjects randomised to receive sham device plus lifestyle intervention for 24 weeks. Vestal DM sham device Lifestyle modification 150 subjects randomised to receive sham device plus lifestyle intervention for 24 weeks.
- Primary Outcome Measures
Name Time Method Frequency of all device related Serious Adverse Events 24 weeks Frequency of all Device Related Serious Adverse Events (SAEs).
Change in glycated hemoglobin (HbA1c) 24 weeks Change in HbA1c levels over the course of the study
- Secondary Outcome Measures
Name Time Method Participants who achieve HbA1c targets 24 weeks 1. Participants Who Achieve HbA1c \< 7.0 % (53 mmol/Mol) ADA Target (Yes/no),
2. Participants Who Achieve ≥ 0.5% HbA1c reduction (Performance goal of ≥ 50% of active group to be specified in SAP)
3. Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no)Change in Body weight 24 weeks Change in body weight as a percentage
Reduction of HbA1c in relation to weight loss 24 weeks Assessment of reduction in HbA1c (%) per kg weight lost.
Change in BMI 24 weeks Change in BMI across the duration of the study
Change in waist-hip ratio (WHR) 24 weeks Change in waist-hip ratio (WHR) over time
Change in body composition (DXA scan) 24 weeks Change in body composition (body fat percentage; body fat mass; visceral fat; muscle mass; bone mass) measured via a DXA scan
Change in atherogenic index 24 weeks Change in the atherogenic index (ratio of total cholesterol to High Density Lipoprotein (HDL)
Change in Total Cholesterol 24 weeks Change in Total Cholesterol over time
Change in High Density Lipoprotein (HDL) 24 weeks Change in High Density Lipoprotein (HDL) over time
Change in Low Density Lipoprotein (LDL) 24 weeks Change in Low Density Lipoprotein (LDL) over time
Change in Triglycerides 24 weeks Change in Triglycerides over time
Change in Very-low-density lipoprotein (VLDL) 24 weeks Change in Very-low-density lipoprotein (VLDL) over time
Change in pulse rate 24 weeks change in pulse rate over time
Change in Mean arterial pressure (MAP) 24 weeks Change in Mean arterial pressure (MAP). (MAP is approximately equal to (2/3 x DBP) + (1/3 x SP))
Change in fasting plasma glucose 24 weeks Change in fasting plasma glucose
Change in 7 point Self Measured Blood Glucose (SMBG) 24 weeks Change in 7 point SMBG - Ratio to Baseline
Change in anti-diabetic medication 24 weeks Change in anti-diabetic medication. Diabetic medications will be summarized in terms of an increase, decrease or no change in medication, by treatment group. This assessment will be made by suitably qualified members of the study team.
Change in cardiovascular medication 24 weeks Change in cardiovascular medication. The changes in cardiovascular medications will be summarized in terms of an increase, decrease or no change in cardiovascular medication, by treatment group. This assessment will be made by suitably qualified members of the study team.
Change in audit of diabetes dependent Quality of Life (QoL) score 24 weeks Change in Audit of Diabetes Dependent Quality of Life Total Score (ADDQoL)
Tolerability of treatment 24 weeks Tolerability of treatment summarized by:
Duration of Exposure Device usage data Mentor support group usage (hours per week)Change in healthcare resource use 24 weeks Change in healthcare resource use over time
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) 24 weeks Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score over time
Change in EQ-5D-5L 24 weeks Change in EQ-5D-5L quality of life score over time
Frequency of Adverse Events (AEs) 24 weeks Frequency of Adverse Events (AEs) (including Serious Adverse Events (SAEs)).
Frequency of hypoglycemic episodes 24 Weeks Change from baseline
Frequency of episodes resulting with HbA1c > 10% 24 weeks Change from baseline
Change in hearing by means of AMTAS flex device 24 weeks Change from baseline
Trial Locations
- Locations (15)
University of Alabama
🇺🇸Birmingham, Alabama, United States
Adult Medicine of Lake County
🇺🇸Mount Dora, Florida, United States
South Florida Research Organization
🇺🇸Medley, Florida, United States
UC San Diego, Exercise and Physical Activity Resource Center
🇺🇸La Jolla, California, United States
Oviedo Medical Research
🇺🇸Oviedo, Florida, United States
Billings Clinic
🇺🇸Billings, Montana, United States
ActivMed Practices & Research
🇺🇸Portsmouth, New Hampshire, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Biopharma Informatic
🇺🇸McAllen, Texas, United States
Charlottesville Medical Research Center
🇺🇸Charlottesville, Virginia, United States
St. Vincent's University Hospital
🇮🇪Dublin, Ireland
Palm Research Center
🇺🇸Las Vegas, Nevada, United States
Northern California Research
🇺🇸Sacramento, California, United States
New Med Research
🇺🇸Hollywood, Florida, United States
Complete Health Partners
🇺🇸Nashville, Tennessee, United States