Electrical Vestibular Nerve Stimulation (VeNS) Compared to Sham Control As a Means of Improving Glycemic Control in Adults with Type 2 Diabetes Mellitus
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
1 other identifier
interventional
267
2 countries
16
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable type-2-diabetes
Started May 2021
Typical duration for not_applicable type-2-diabetes
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
May 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 6, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 6, 2024
CompletedSeptember 19, 2024
September 1, 2024
3.2 years
October 12, 2020
September 9, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Change in glycated hemoglobin (HbA1c)
Change in HbA1c levels over the course of the study
24 weeks
Frequency of all device related Serious Adverse Events
Frequency of all Device Related Serious Adverse Events (SAEs).
24 weeks
Secondary Outcomes (27)
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
- +22 more secondary outcomes
Study Arms (2)
Vestal DM active device
EXPERIMENTAL150 subjects randomised to receive active device plus lifestyle intervention for 24 weeks
Vestal DM sham device
SHAM COMPARATOR150 subjects randomised to receive sham device plus lifestyle intervention for 24 weeks.
Interventions
Battery powered non-invasive neurostimulation device
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)
Placebo comparator sham device (no active stimulation)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neurovalens Ltd.lead
- University College Dublincollaborator
- CS Lifesciencecollaborator
- Clinical Trial Mentorscollaborator
Study Sites (16)
University of Alabama
Birmingham, Alabama, 35294, United States
UC San Diego, Exercise and Physical Activity Resource Center
La Jolla, California, 92093, United States
Northern California Research
Sacramento, California, 95821, United States
New Med Research
Hollywood, Florida, 33020, United States
South Florida Research Organization
Medley, Florida, 33166, United States
Adult Medicine of Lake County
Mt. Dora, Florida, 32757, United States
Oviedo Medical Research
Oviedo, Florida, 32765, United States
ActivMed Practices & Research
Methuen, Massachusetts, 01844, United States
Billings Clinic
Billings, Montana, 59101, United States
Palm Research Center
Las Vegas, Nevada, 89148, United States
ActivMed Practices & Research
Portsmouth, New Hampshire, 03801, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Complete Health Partners
Nashville, Tennessee, 37209, United States
Biopharma Informatic
McAllen, Texas, 78503, United States
Charlottesville Medical Research Center
Charlottesville, Virginia, 22911, United States
St. Vincent's University Hospital
Dublin, Dublin, D04 T6F4, Ireland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik Viirre, MD PhD
UC San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2020
First Posted
October 22, 2020
Study Start
May 21, 2021
Primary Completion
August 6, 2024
Study Completion
August 6, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09