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

Official title

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

Overview

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

Detailed description

This is a prospective, multi-center, longitudinal study to evaluate the proportion of cardiovascular events in diabetic mellitus patients identified by HEMOTAG evaluations, utilizing cardiac time interval measurements being treated in outpatient clinics. An enriched diabetic patient population, currently undergoing standard medical care for their diabetes management (per the American Diabetes Association) will be invited to participate within this study. All patients will complete their standard of care assessments including, vital signs, creatinine, eGFR, fasting Cholesterol (including HDL and LDL), HbA1c,and NT-pro BNP, at their regularly scheduled diabetic clinic visits. During the enrollment visit, patients will undergo a baseline HEMOTAG evaluation, cardiovascular event assessment as well as baseline questionnaire assessments. Patients will be shipped a HEMOTAG device with electrodes, and HEMOTAG measurements will be conducted at least three days a week for a 30-day period at-home. This will occur after the Baseline Visit, after the 6-month Visit, and following any hospitalizations due to cardiac events during the 12-month study.

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. Results of standard of care assessments including, vital signs, creatinine, eGFR, fasting Cholesterol (including HDL/LDL),and HbA1c, will be collected if performed during their regularly scheduled diabetic clinic visits. 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. Results from cardiac testing (examples: Echo, Cardiac Catheterization, Stress Tests, etc) that may occur during the 12-month monitoring period will be collected as part of this study.

Interventions

• Device Hemotag
  Hemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days

Primary outcome measures

• To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration. [Time frame: 12 months]

Secondary outcome measures (9)

• Secondary objective will evaluate various cardiac events occurring over time throughout the observational period as well as quality of life measurements for 6 months. [Time frame: 6 months]
• Correlation of AO and CE at 6 and 12 months [Time frame: 12 months]
• Correlation of CTI and CE at 6 and 12 months [Time frame: 12 months]
• All Deaths for 12 months [Time frame: 12 months]
• Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months [Time frame: 12 months]
• Six Minute Walk Test (Borg Dyspnea/Borg Fatigue Scale) [Time frame: 12 months]
• Median time to heart failure at 6 and 12 months [Time frame: 12 months]
• Median time to Left Ventricular Dysfunction at 6 and 12 months [Time frame: 12 months]
• Health State as measured by the EQ5D5L ( EuroQol 5 Dimensions 5 Levels) [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Terminal condition with life expectancy less than 12 months as determined by investigator.
• Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment.
• 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).
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Metabolic Research Institute, Inc — West Palm Beach

Identifiers

NCT: NCT06567795 · HT-101-VV-032 · R44HL149561-03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗