To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.
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)
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).
Any patients that meet inclusion exclusion criteria
Cohort
Prospective
Hemotag
DeviceHemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days
To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration.
The primary endpoint will be to evaluate CV events measured by a composite endpoint defined by unplanned hospitalizations, emergency room visits/urgent care visits (that do not result in hospitalization), for cardiovascular events or death within the observation period of 12 months.
Secondary objective will evaluate various cardiac events occurring over time throughout the observational period as well as quality of life measurements for 6 months.
Composite endpoint consisting of unplanned hospitalizations, emergency room visits/urgent care visits (that do not result in hospitalization), for cardiovascular events or death within the observation period of 6 months.
Correlation of AO and CE at 6 and 12 months
Correlation of AO and CE at 6 and 12 months
Correlation of CTI and CE at 6 and 12 months
Correlation of CTI and CE at 6 and 12 months
All Deaths for 12 months
All Deaths for 12 months
All cause hospitalizations
All cause hospitalizations
Health Status as measured by the LVD-36
Health Status as measured by the LVD-36 Low Scores: Indicate fewer symptoms and better quality of life. High Scores: Indicate more severe symptoms and poorer quality of life.
Productivity questionnaire
Productivity questions deal with how health issues or their treatment have affected the subject's ability to remain in the workforce and perform daily activities in the home.
Health care resource utilization
Health care resource utilization Frequency of visits to the emergency department within 30 days Rates of patients being readmitted to the hospital within a 30 day time period. Reporting of outpatient visits within 30 days
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Aventusoft, LLC.
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
