PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorAventusoft, LLC.

About this trial

To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.

Eligibility criteria

Qualifiers

Adult patients older than 40 years of age.

Diagnosis of Type 2 Diabetes Mellitus (insulin dependent or non-insulin dependent) for at least 5 years.

Diagnosis of Cardiovascular Disease (Coronary Artery Disease, Cerebrovascular Disease, Peripheral Artery Disease, etc…) --OR--

Diabetic Retinopathy (proliferative or non-proliferative)

Disqualifiers

Terminal condition with life expectancy less than 12 months as determined by investigator.

Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment.

Illness/ Condition which may be aggravated or cause significant discomfort to the patient by the application of the HEMOTAG (skin issues, e.g. Intolerance to use of skin electrodes).

Participant enrolled in another interventional study (observational or registries are not excluded).

Trial design

Treatments tested in this trial

  • Hemotag

Treatment groups

189 Participants
are divided into 1 treatment group

Sponsors and collaborators

Aventusoft, LLC.

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator