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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
Must not have
Diagnosis of Type 1 diabetes mellitus
Diagnosis of diabetic neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
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.
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.
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with Type 1 diabetes.
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I have been diagnosed with diabetic neuropathy.
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I have been diagnosed with diabetic kidney disease.
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I have been diagnosed with retinopathy.
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I am currently taking insulin or have stopped it for at least 90 days.
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I have had pancreatitis before.
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I have had surgery on my pancreas.
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I have been diagnosed with hemochromatosis.
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I have had a heart attack or acute coronary syndrome in the last year.
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I have had a stroke in the past.
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I have a history of epilepsy.
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I have had my spleen removed.
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I have not had a blood transfusion in the last 90 days.
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I am not taking supplements or herbal remedies that affect blood sugar levels.
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I have been diagnosed with failure of the kidney, heart, or liver.
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I have a history of severe headaches with visual disturbances.
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I have had a severe head injury that needed intensive care or surgery.
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I am currently taking medication for stomach acid, like famotidine.
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I haven't had any cancer except for skin cancer or in-situ carcinomas in the last year.
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I have been diagnosed with myelofibrosis or a myelodysplastic syndrome.
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I have had issues with my inner ear or balance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in glycated hemoglobin (HbA1c)
Frequency of all device related Serious Adverse Events
Secondary study objectives
Change in 7 point Self Measured Blood Glucose (SMBG)
Change in BMI
Change in Body weight
+14 moreTrial 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
2019
Completed Phase 4
~3390
Find a Location
Who is running the clinical trial?
Clinical Trial MentorsIndustry Sponsor
3 Previous Clinical Trials
474 Total Patients Enrolled
CS LifescienceUNKNOWN
University College DublinOTHER
151 Previous Clinical Trials
127,351 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Vestal DM active device
- Group 2: Vestal DM sham device
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT04595968 — N/A
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