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

Other illness

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

Other

• Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment.
• Participant enrolled in another interventional study (observational or registries are not excluded).
• Prisoners and wards of the state.
• Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator\'s assessment.
• Participants unable to provide informed, voluntary decision to participate in research study as determined by the investigator. (Exclude participants who necessitate the involvement of a legally authorized representative.)
• Inability to provide informed consent (Must speak English).
• Women who are pregnant or are planning to become pregnant during the study.
• Women of childbearing potential who are unwilling or unable to comply with contraception measures.

• 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--
  • Have one (1) of the following concomitant medical diagnoses:
  • Diabetic Retinopathy (proliferative or non-proliferative)
  • Diabetic Nephropathy (eGFR \<60 mL/min/1.73m2 and/or urine albumin/creatinine ratio ≥30 mg/g)
  • Diabetic Neuropathy
  • Elevated High-sensitivity C-reactive protein (hs-CRP) --AND--
  • Have a history of two (2) or more of the following:
  • Diagnosis of Hypertension for at least 6 months or more (treated or untreated)
  • Hypercholesterolemia (LDL-C \>100 mg/dL)
  • Obesity (Body Mass Index (BMI) ≥ 27 for men or ≥ 22 for women)
  • History of Smoking
• Willingness to undergo HEMOTAG evaluation.
• Willingness to undergo Standard of Care visits/assessments and NT-pro BNP lab evaluations.
• Willingness to conduct at-home HEMOTAG evaluations at least three days per week within a 30-day time period after the completion of the Baseline Visit, after the 6 month visit and following discharge from any hospitalizations due to a cardiac events during the 12 month study period.
• Willingness to receive and return shipping of the HEMOTAG KIT at each time point as required by the protocol
• Able to give informed consent.