Evaluating cardiovascular events in diabetic patients using HEMOTAG

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the proportion of cardiovascular events in patients with Type 2 Diabetes Mellitus through evaluations using the HEMOTAG device. It is a prospective, multi-center, longitudinal study where participants will undergo standard medical care assessments and HEMOTAG evaluations at home over a 30-day period. Patients will be monitored for cardiovascular events and will complete follow-up assessments at 6 and 12 months. The study focuses on an enriched population of diabetic patients with additional cardiovascular risk factors.

Why it matters

Who can join: the full rules

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.

Where it's running

• Metabolic Research Institute, Inc
  West Palm Beach, Florida, United States Recruiting

Study contacts

• Study coordinator: Cindy Kober, Bs
• Email: cindy@aventusoft.com
• Phone: 954-399-3335

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.