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VeNS for Type 2 Diabetes
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.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have had a heart attack or acute coronary syndrome in the last year.I have not had a blood transfusion in the last 90 days.I have been diagnosed with failure of the kidney, heart, or liver.I regularly use antihistamines but can switch to Fexofenadine for the trial.I was diagnosed with Type 2 diabetes more than 90 days ago.I've been on a stable dose of up to 3 diabetes medications for the last 3 months.I have been diagnosed with myelofibrosis or a myelodysplastic syndrome.You have used the Modius device before.I have had issues with my inner ear or balance.I had anemia but it's been treated and resolved for over 90 days.I have had a severe head injury that needed intensive care or surgery.I have a history of severe headaches with visual disturbances.I haven't changed my diabetes medication in the last 3 months.I am regularly seeing a doctor for my type 2 diabetes management.I am currently taking medication for stomach acid, like famotidine.I have a history of epilepsy.I am currently taking insulin or have stopped it for at least 90 days.I have had surgery on my pancreas.I do not have skin conditions like eczema or psoriasis behind my ears that could affect my participation.I have had my spleen removed.I have had pancreatitis before.I have a blood disorder like sickle cell disease or thalassemia.I haven't had any cancer except for skin cancer or in-situ carcinomas in the last year.You did not pass the ATMAS Flex hearing test.You are not willing to make changes to your diet and exercise, if your BMI is 25 or higher.I have been diagnosed with hemochromatosis.I have had a stroke in the past.I am not pregnant, breastfeeding, planning to become pregnant, or if of child-bearing potential, I am using effective contraception.I have been diagnosed with diabetic kidney disease.If you are not in the US, your body mass index (BMI) is 25 or higher.I am not currently on beta-blockers or have been off them for at least 30 days.I am not on any medication that could cause diabetes, except for topical steroids.I have been diagnosed with Type 1 diabetes.I have been diagnosed with diabetic neuropathy.I have been diagnosed with retinopathy.I am between 22 and 70 years old and live in the US, or I am between 18 and 70 years old and live outside the US.Your HbA1c (glycated hemoglobin) level is between 6.5% and 9.5%.I am not taking supplements or herbal remedies that affect blood sugar levels.
- Group 1: Vestal DM active device
- Group 2: Vestal DM sham device
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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"
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
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How responsive is this trial?
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Most responsive sites:
- University of Alabama: < 48 hours
Average response time
- < 2 Days
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