Cure My Disease

Don't miss your cure!

 Log in / Sign up

Heartbeat test aims to catch hidden nerve damage in diabetes

NCT ID NCT04964921

NEW Diagnosis Sponsor: DyAnsys, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a device called ANSiScope Plus can identify autonomic dysfunction by measuring heart rate variability. Participants include healthy adults and people with prediabetes or type 2 diabetes, some with complications like nerve, kidney, or eye damage. Each person attends one visit where their vital signs and ECG are recorded. The team will compare five methods of analyzing heartbeat intervals to see which one best separates the groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ANSiScope Plus, a device that measures heart rate variability and vital signs
What this could lead to
If it works, this approach could give doctors a simple, non-invasive way to spot autonomic nerve damage in people with diabetes earlier than current methods allow.
What could go wrong
This is a small, single-visit study with no enrollment listed, so the results may not hold up in larger groups. The device only measures nerve signals; it does not treat or reverse any damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Expected to start

Jun 2022

An estimate. Start dates often move.

Expected to finish

Oct 2022

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adults of either sex with various stages of impaired fasting glucose tolerance levels and diabetes (with or without complications) will be considered as study population.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Can provide informed consent. * Age between 18 and 85 years old * Body Mass Index: 25 ≤ BMI ≤ 40 * Hemoglobin A1c level: 7.5 ≤ HbA1c ≤ 9.5 * Individuals with pre-diabetes and diabetes Type II for at least 1 year (diagnosed by ADA criteria) and up to 20 years * Advanced diabetic complications including neuropathy, nephropathy, retinopathy and other related complications * Stable dose of medications for the previous 3 months * Stable diet and lifestyle for the previous 3 months * Stable medical status (Ex: no myocardial infarction, stroke, major surgery, Exclusion Criteria: * Unable to provide informed consent * Chronic disease (e.g. HIV, Cushing syndrome, CKD, acromegaly, active hyperthyroidism etc.) * Cancer and anticancer treatment in the last 5 years * Psychiatric disorders (that in the eyes of the investigator should exclude the participant) * Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol * Organ (kidney, pancreas, liver) transplant recipients * Pregnancy or lactation * Positive drug screen (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol) * Alcoholics or Smokers * Positive screen on HBsAg, anti-HCV or anti-HIV ½ * History of diabetic ketoacidosis or hyperosmolar coma * Subjects with known coronary artery disease or coronary revascularisation * Subjects with previous history of cerebrovascular accident * Subjects with known proliferative retinopathy or previous laser treatment for diabetic retinopathy * Subjects with life-threatening conditions including malignancy * Subjects with known psychiatric conditions including depression * Subjects with significant renal impairment (eGFR\<60ml/min at baseline) or non-diabetic renal disease (e.g. biopsy-proven glomerulonephritis or obstructive uropathy) * Subjects with major physical disability

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diabetes are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

diabetes mellitus prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes

More trials for these conditions

Other studies related to the condition(s) this trial covers.