Prospective, Multi-center, Longitudinal, Study for PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
Aventusoft, LLC.
Summary
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.
Description
This is a prospective, multi-center, longitudinal study to evaluate the proportion of cardiovascular events in diabetic mellitus patients identified by HEMOTAG evaluations, utilizing cardiac time interval measurements being treated in outpatient clinics. An enriched diabetic patient population, currently undergoing standard medical care for their diabetes management (per the American Diabetes Association) will be invited to participate within this study. All patients will complete their standard of care assessments including, vital signs, creatinine, eGFR, fasting Cholesterol (including HDL an…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult patients older than 40 years of age. 2. Diagnosis of Type 2 Diabetes Mellitus (insulin dependent or non-insulin dependent) for at least 5 years. 3. Diagnosis of Cardiovascular Disease (Coronary Artery Disease, Cerebrovascular Disease, Peripheral Artery Disease, etc…) --OR-- Have one (1) of the following concomitant medical diagnoses: 1. Diabetic Retinopathy (proliferative or non-proliferative) 2. Diabetic Nephropathy (eGFR \<60 mL/min/1.73m2 and/or urine albumin/creatinine ratio ≥30 mg/g) 3. Diabetic Neuropathy 4. Elevated High-sensitivity C-rea…
Interventions
- DeviceHemotag
Hemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days
Location
- Metabolic Research Institute, IncWest Palm Beach, Florida