Type 2 DiabetesNCT04595968
Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus
A study testing Vestal DM Active device and Lifestyle modification in people with Type 2 Diabetes, run by Neurovalens Ltd. at 16 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Vestal DM Active device and Lifestyle modification
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 21 May 2021to 6 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States15 sites
Billings Clinic
Billings, Montana, 59101
University of Alabama
Birmingham, Alabama, 35294
Charlottesville Medical Research Center
Charlottesville, Virginia, 22911
New Med Research
Hollywood, Florida, 33020
UC San Diego, Exercise and Physical Activity Resource Center
La Jolla, California, 92093
Palm Research Center
Las Vegas, Nevada, 89148
Biopharma Informatic
McAllen, Texas, 78503
South Florida Research Organization
Medley, Florida, 33166
ActivMed Practices & Research
Methuen, Massachusetts, 01844
Adult Medicine of Lake County
Mt. Dora, Florida, 32757
Complete Health Partners
Nashville, Tennessee, 37209
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Oviedo Medical Research
Oviedo, Florida, 32765
ActivMed Practices & Research
Portsmouth, New Hampshire, 03801
Northern California Research
Sacramento, California, 95821
About this study
Official 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
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.
Read more
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.
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Vestal DM Active device, Lifestyle modification, Vestal DM Sham device
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestal DM Active deviceDevice
Battery powered non-invasive neurostimulation device
Lifestyle modificationBehavioural
Subjects are prescribed a low calorie (500kcal deficit) diet if their BMI is ≥25. If a subject has a BMI of ≤24.9, they will be provided with guidance on ensuring their recommended daily dietary intake is achieved throughout the course of the trial (i.e 2,500kcal/day for men and 2,000kcal/day for women)
Vestal DM Sham deviceDevice
Placebo comparator sham device (no active stimulation)
| Study group | Role | What they receive |
|---|---|---|
| Vestal DM active device | Experimental | 150 subjects randomised to receive active device plus lifestyle intervention for 24 weeks Receives: Device: Vestal DM Active device; Behavioral: Lifestyle modification |
| Vestal DM sham device | Sham comparator | 150 subjects randomised to receive sham device plus lifestyle intervention for 24 weeks. Receives: Behavioral: Lifestyle modification; Device: Vestal DM Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycated hemoglobin (HbA1c)
Change in HbA1c levels over the course of the study
Measured: 24 weeks
Frequency of all device related Serious Adverse Events
Frequency of all Device Related Serious Adverse Events (SAEs).
Measured: 24 weeks
Secondary outcomes (27)
Participants who achieve HbA1c targets
- Participants Who Achieve HbA1c < 7.0 % (53 mmol/Mol) ADA Target (Yes/no),
- Participants Who Achieve ≥ 0.5% HbA1c reduction (Performance goal of ≥ 50% of active group to be specified in SAP)
- Participants Who Achieve HbA1c ≤ 6.5 % (48 mmol/Mol) AACE Target (Yes/no)
Measured: 24 weeks
Change in Body weight
Change in body weight as a percentage
Measured: 24 weeks
Reduction of HbA1c in relation to weight loss
Assessment of reduction in HbA1c (%) per kg weight lost.
Measured: 24 weeks
Change in BMI
Change in BMI across the duration of the study
Measured: 24 weeks
Change in waist-hip ratio (WHR)
Change in waist-hip ratio (WHR) over time
Measured: 24 weeks
Change in body composition (DXA scan)
Change in body composition (body fat percentage; body fat mass; visceral fat; muscle mass; bone mass) measured via a DXA scan
Measured: 24 weeks
Change in atherogenic index
Change in the atherogenic index (ratio of total cholesterol to High Density Lipoprotein (HDL)
Measured: 24 weeks
Change in Total Cholesterol
Change in Total Cholesterol over time
Measured: 24 weeks
Change in High Density Lipoprotein (HDL)
Change in High Density Lipoprotein (HDL) over time
Measured: 24 weeks
Change in Low Density Lipoprotein (LDL)
Change in Low Density Lipoprotein (LDL) over time
Measured: 24 weeks
Change in Triglycerides
Change in Triglycerides over time
Measured: 24 weeks
Change in Very-low-density lipoprotein (VLDL)
Change in Very-low-density lipoprotein (VLDL) over time
Measured: 24 weeks
Change in pulse rate
change in pulse rate over time
Measured: 24 weeks
Change in Mean arterial pressure (MAP)
Change in Mean arterial pressure (MAP). (MAP is approximately equal to (2/3 x DBP) + (1/3 x SP))
Measured: 24 weeks
Change in fasting plasma glucose
Change in fasting plasma glucose
Measured: 24 weeks
Change in 7 point Self Measured Blood Glucose (SMBG)
Change in 7 point SMBG - Ratio to Baseline
Measured: 24 weeks
Change in anti-diabetic medication
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.
Measured: 24 weeks
Change in cardiovascular medication
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.
Measured: 24 weeks
Change in audit of diabetes dependent Quality of Life (QoL) score
Change in Audit of Diabetes Dependent Quality of Life Total Score (ADDQoL)
Measured: 24 weeks
Tolerability of treatment
Tolerability of treatment summarized by:
Duration of Exposure Device usage data Mentor support group usage (hours per week)
Measured: 24 weeks
Change in healthcare resource use
Change in healthcare resource use over time
Measured: 24 weeks
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score over time
Measured: 24 weeks
Change in EQ-5D-5L
Change in EQ-5D-5L quality of life score over time
Measured: 24 weeks
Frequency of Adverse Events (AEs)
Frequency of Adverse Events (AEs) (including Serious Adverse Events (SAEs)).
Measured: 24 weeks
Frequency of hypoglycemic episodes
Change from baseline
Measured: 24 Weeks
Frequency of episodes resulting with HbA1c > 10%
Change from baseline
Measured: 24 weeks
Change in hearing by means of AMTAS flex device
Change from baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start21 May 2021
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurovalens Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College Dublin, CS Lifescience, Clinical Trial Mentors
- Responsible party
- Sponsor
- Investigators
- Erik Viirre, MD PhD, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595968
- Sponsor's protocol ID
- VeSTALDM01
- Status last verified
- Sep 2024
- First submitted
- 12 Oct 2020
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04595968
- Acronym / sponsor ID
- VeSTALDM01
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Neurovalens Ltd.Industry (pharma, biotech, devices)
- Collaborators
- University College Dublin, CS Lifescience, Clinical Trial Mentors
- Study start
- 21 May 2021 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestal DM active device | Experimental | Device: Vestal DM Active device, Behavioral: Lifestyle modification150 subjects randomised to receive active device plus lifestyle intervention for 24 weeks |
| Vestal DM sham device | Sham comparator | Behavioral: Lifestyle modification, Device: Vestal DM Sham device150 subjects randomised to receive sham device plus lifestyle intervention for 24 weeks. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (38 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestal DM Active deviceBattery powered non-invasive neurostimulation device | Device | Vestal DM active device |
| Lifestyle modificationSubjects are prescribed a low calorie (500kcal deficit) diet if their BMI is ≥25. If a subject has a BMI of ≤24.9, they will be provided with guidance on ensuring their recommended daily dietary intake is achieved throughout the course of the trial (i.e 2,500kcal/day for men and 2,000kcal/day for women) | Behavioural | Vestal DM active device, Vestal DM sham device |
| Vestal DM Sham devicePlacebo comparator sham device (no active stimulation) | Device | Vestal DM sham device |
Primary outcome
Change in glycated hemoglobin (HbA1c)
Time frame: 24 weeks
Change in HbA1c levels over the course of the study
Frequency of all device related Serious Adverse Events
Time frame: 24 weeks
Frequency of all Device Related Serious Adverse Events (SAEs).
27 secondary outcomes
Participants who achieve HbA1c targets
Time frame: 24 weeks
Change in Body weight
Time frame: 24 weeks
Reduction of HbA1c in relation to weight loss
Time frame: 24 weeks
Change in BMI
Time frame: 24 weeks
Change in waist-hip ratio (WHR)
Time frame: 24 weeks
Change in body composition (DXA scan)
Time frame: 24 weeks
Change in atherogenic index
Time frame: 24 weeks
Change in Total Cholesterol
Time frame: 24 weeks
Change in High Density Lipoprotein (HDL)
Time frame: 24 weeks
Change in Low Density Lipoprotein (LDL)
Time frame: 24 weeks
Change in Triglycerides
Time frame: 24 weeks
Change in Very-low-density lipoprotein (VLDL)
Time frame: 24 weeks
Change in pulse rate
Time frame: 24 weeks
Change in Mean arterial pressure (MAP)
Time frame: 24 weeks
Change in fasting plasma glucose
Time frame: 24 weeks
Change in 7 point Self Measured Blood Glucose (SMBG)
Time frame: 24 weeks
Change in anti-diabetic medication
Time frame: 24 weeks
Change in cardiovascular medication
Time frame: 24 weeks
Change in audit of diabetes dependent Quality of Life (QoL) score
Time frame: 24 weeks
Tolerability of treatment
Time frame: 24 weeks
Change in healthcare resource use
Time frame: 24 weeks
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: 24 weeks
Change in EQ-5D-5L
Time frame: 24 weeks
Frequency of Adverse Events (AEs)
Time frame: 24 weeks
Frequency of hypoglycemic episodes
Time frame: 24 Weeks
Frequency of episodes resulting with HbA1c > 10%
Time frame: 24 weeks
Change in hearing by means of AMTAS flex device
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Viirre, MD PhD principal investigator
UC San Diego
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestal DM Active device and Lifestyle modification in people with Type 2 Diabetes, run by Neurovalens Ltd. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated hemoglobin (HbA1c) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.