Evaluating cardiovascular events in diabetic patients using HEMOTAG

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

This study is testing how well the HEMOTAG device can help track heart problems in people with Type 2 Diabetes who also have other heart risk factors.

Quick facts

• Study type: Observational
• Enrollment: 189 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Aventusoft, LLC. (industry)
• Locations: 1 site (West Palm Beach, Florida)
• Trial ID: NCT06567795 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults over 40 with Type 2 Diabetes Mellitus and existing cardiovascular diseases or related complications.

Not a fit: Patients without a diagnosis of Type 2 Diabetes Mellitus or those under 40 years of age may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the monitoring and management of cardiovascular risks in diabetic patients, potentially leading to better health outcomes.

How similar studies have performed: Other studies have shown promise in using similar monitoring technologies for cardiovascular risk assessment in diabetic populations.

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.

Where this trial is running

West Palm Beach, Florida

• Metabolic Research Institute, Inc — West Palm Beach, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: CINDY KOBER, BS

Conditions: Diabetes Mellitus Type 2, Cardiovascular Diseases, Coronary Artery Disease, Cerebrovascular Disease, Peripheral Artery Disease, Diabetes Mellitus