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

Prospective, Multi-center, Longitudinal, Study for PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 12 visits
  • Time periods mentioned: 12 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "During the enrollment visit, patients will undergo a baseline HEMOTAG evaluation, cardiovascular event assessment as well as baseline questionnaire assessments."
  • "All patients will undergo standard of care follow-up visits at their normal 6 month and 12 month visits and will repeat the HEMOTAG evaluation (in clinic), cardiovascular event assessment, NT-pro BNP, as well as questionnaire assessments."
  • "Throughout the course of this study, all study participant's medical records will reviewed and assessed for the occurrence of cardiac events (including hospitalizations, emergency room visits/urgent care visits, other cardiac assessments, and death) for up to 12 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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-reactive protein (hs-CRP) --AND-- Have a history of two (2) or more of the following: 5. Diagnosis of Hypertension for at least 6 months or more (treated or untreated) 6. Hypercholesterolemia (LDL-C \>100 mg/dL) 7. Obesity (Body Mass Index (BMI) ≥ 27 for men or ≥ 22 for women) 8. History of Smoking 4. Willingness to undergo HEMOTAG evaluation. 5. Willingness to undergo Standard of Care visits/assessments and NT-pro BNP lab evaluations. 6. 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. 7. Willingness to receive and return shipping of the HEMOTAG KIT at each time point as required by the protocol 8. Able to give informed consent. Exclusion Criteria: 1. Terminal condition with life expectancy less than 12 months as determined by investigator. 2. Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment. 3. 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). 4. Participant enrolled in another interventional study (observational or registries are not excluded). 5. Prisoners and wards of the state. 6. Impaired cognitive ability or any other state that may prevent full compliance with the study protocol, according to investigator\'s assessment. 7. 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.) 8. Inability to provide informed consent (Must speak English). 9. Women who are pregnant or are planning to become pregnant during the study. 10. Women of childbearing potential who are unwilling or unable to comply with contraception measures.

Study sites (1)

FL