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

Launched by AVENTUSOFT, LLC. · Aug 21, 2024

Keywords

ClinConnect Summary

This clinical trial, called "PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG," is looking into how common heart-related issues are in people with Type 2 Diabetes. The study will use a device called HEMOTAG to help monitor these events. It is currently recruiting participants who are at least 40 years old and have had Type 2 Diabetes for at least five years. Eligible participants should also have some form of heart disease or other related health issues, such as diabetic eye problems or kidney issues, along with a history of conditions like high blood pressure or high cholesterol.

If you decide to join this study, you will be asked to use the HEMOTAG device at home several times a week for up to a year, after completing some initial visits and tests. You will also have regular check-ups with your healthcare team. It’s important to know that you need to be able to give your consent to participate and be comfortable with using the HEMOTAG device. This trial aims to better understand how diabetes affects heart health, which could help improve care for future patients.

Gender

ALL

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.