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VeNS for Type 2 Diabetes

N/A
Waitlist Available
Led By Erik Viirre, MD PhD
Research Sponsored by Neurovalens Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study Summary

This trial is testing whether a device that sends electrical pulses to the vestibular nerve can help improve glycemic control in adults with type 2 diabetes, as compared to a sham control. The study will last 24 weeks for each subject, and the primary analysis will be conducted at the 24-week time point.

Who is the study for?
Adults aged 22-70 in the US (18-70 outside the US) with Type 2 diabetes for over 90 days, stable on up to three diabetes medications, and an HbA1c level between 6.5% and 9.5%. Participants must have Wi-Fi, continue their routine care, and not have certain medical conditions like implanted devices or a history of severe head injury.Check my eligibility
What is being tested?
The trial is testing if non-invasive electrical stimulation of the vestibular nerve (VeNS), along with lifestyle changes, can better control blood sugar levels compared to a sham device plus lifestyle changes in people with Type 2 diabetes. It's randomized and double-blind with equal numbers getting either the active or sham device.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include discomfort from wearing the device behind the ears or skin irritation at contact points. Since it's non-invasive, risks might be lower than drug interventions; however, specific side effects will be monitored throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in glycated hemoglobin (HbA1c)
Frequency of all device related Serious Adverse Events
Secondary outcome measures
Change in 7 point Self Measured Blood Glucose (SMBG)
Change in BMI
Change in Body weight
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vestal DM active deviceExperimental Treatment2 Interventions
150 subjects randomised to receive active device plus lifestyle intervention for 24 weeks
Group II: Vestal DM sham devicePlacebo Group2 Interventions
150 subjects randomised to receive sham device plus lifestyle intervention for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle modification
2017
Completed Phase 4
~2600

Find a Location

Who is running the clinical trial?

Clinical Trial MentorsIndustry Sponsor
3 Previous Clinical Trials
374 Total Patients Enrolled
CS LifescienceUNKNOWN
University College DublinOTHER
142 Previous Clinical Trials
108,998 Total Patients Enrolled

Media Library

Lifestyle modification Clinical Trial Eligibility Overview. Trial Name: NCT04595968 — N/A
Type 2 Diabetes Research Study Groups: Vestal DM active device, Vestal DM sham device
Type 2 Diabetes Clinical Trial 2023: Lifestyle modification Highlights & Side Effects. Trial Name: NCT04595968 — N/A
Lifestyle modification 2023 Treatment Timeline for Medical Study. Trial Name: NCT04595968 — N/A
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04595968 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria to partake in this medical research?

"This investigation is enrolling 300 persons who are between 22 and 70 years of age with type 2 diabetes mellitus. To be considered, participants ought to have been on a stable dosage of fewer than three anti-diabetic medications for 90 days preceding enrolment as well as under the care of either an endocrinologist or hospitalist. Additionally, potential trialists must yield their informed consent prior to any activities related to the research, possess access to Wi-Fi, come within seven years from diagnosis at US sites (any time worldwide in non-US countries), and present HbA1c levels ranging from 6.5%–9"

Answered by AI

Is participation in this clinical research only open to individuals under the age of 45?

"The study is available to those aged between 22 and 70. Those under 18 have 192 studies they may be eligible for, while 1103 are open to seniors over the age of 65."

Answered by AI

How many individuals have been accepted to partake in this experiment?

"Affirmative. According to information on clinicaltrials.gov, the trial remains open for recruitment and was initially posted on May 21st 2021. The most recent alteration of the listing took place November 3rd 2022 and 300 individuals will be accepted across 7 sites."

Answered by AI

What are the main aims associated with this clinical investigation?

"The primary endpoint of this 24-week trial is Standardized Incidence Ratio for all device related Serious Adverse Events. Meanwhile, secondary goals include a modification in cardiovascular medication (increase/decrease/no change), reduced HbA1c levels relative to lost weight and BMI changes over the assessment period; these outcomes will be evaluated by expert members of the research group."

Answered by AI

Is this experiment enrolling participants at present?

"The details of the trial hosted on clinicaltrials.gov indicate that this study is currently recruiting participants. The trial was published online in May 2021 and recently updated in November 2022."

Answered by AI

How many venues are the research activities for this study conducted in?

"Several locations are offering this trial, such as South Florida Research Organization in Medley, Nevada, Palm Research Center in Las Vegas, Virginia and Oviedo Medical Research in Oviedo, California."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Northern California Research
UC San Diego, Exercise and Physical Activity Resource Center
Palm Research Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

How long do screening visits take? Am I reimbursed for travel to C'Ville, etc.?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

Help people with their Diabetes. I received an email with details about this trial. I have Type 2 diabetes and although I've lowered my A1C through diet I'd like more options.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. University of Alabama: < 48 hours
Average response time
  • < 2 Days
~8 spots leftby Jun 2024