Hemotag for Diabetes and Cardiovascular Disease

(PRIZETAG Trial)

Overseen By Ali Hamadeh, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aventusoft, LLC.

Disqualifiers: Terminal condition, Physical deformity, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

189 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a tool called HEMOTAG tracks heart-related issues in individuals with diabetes. The focus is on those who have had Type 2 Diabetes for at least five years and also have cardiovascular disease or related conditions, such as diabetic eye, kidney, or nerve problems. Participants should also have high blood pressure, high cholesterol, obesity, or a history of smoking. The trial will assess the effectiveness of combining HEMOTAG with regular diabetes care over a year. Participants must be comfortable using HEMOTAG at home and attending regular medical check-ups. As a Phase 2 trial, this research measures HEMOTAG's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in diabetes care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that HEMOTAG is safe for diabetic mellitus patients?

Research has shown that HEMOTAG, a device for monitoring heart health in people with diabetes, has undergone testing on diabetic patients. In one study involving 56 diabetic patients, daily recordings from the HEMOTAG device demonstrated its safety, with no serious side effects reported. This indicates the device is generally well-tolerated. However, it is important to consult a healthcare provider before joining a trial to understand any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using HEMOTAG for diabetic patients with cardiovascular risks because it offers a personalized approach to monitoring heart health. Unlike existing treatments that primarily focus on managing blood sugar levels or using medications like statins to manage cholesterol, HEMOTAG provides real-time insights into cardiovascular events. This allows for more tailored interventions. By identifying potential issues early, it could potentially prevent serious heart complications in people with diabetes, which is a significant advancement over the current standard of care.

What evidence suggests that HEMOTAG is effective for evaluating cardiovascular events in diabetic patients?

Research shows that people with diabetes face a high risk of heart disease, a leading cause of health issues and death in this group. Studies have found that controlling blood pressure can significantly reduce this risk. In this trial, researchers are testing HEMOTAG alongside standard care to track heart-related events in people with diabetes. Early results suggest that using HEMOTAG, in conjunction with regular care, might help monitor and potentially improve heart health by providing detailed information about their heart condition. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes for at least 5 years.

I have been diagnosed with a heart or blood vessel disease.

I have diabetic retinopathy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants undergo a baseline HEMOTAG evaluation, cardiovascular event assessment, and baseline questionnaire assessments

1 day

1 visit (in-person)

Home Monitoring

Participants conduct HEMOTAG measurements at least three days a week for a 30-day period at-home

4 weeks

Standard of Care Follow-up

Participants undergo standard of care follow-up visits at 6 and 12 months, including HEMOTAG evaluation and cardiovascular event assessment

12 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including review of medical records for cardiac events

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Hemotag

How Is the Trial Designed?

Group I: HEMOTAG with Standard of Care in DM patients Experimental Treatment 1 Intervention

HEMOTAG with Standard of Care: To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration.

Who Is Running the Clinical Trial?

Aventusoft, LLC.

Lead Sponsor

Trials

2

Recruited

610+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1.

trialx.com

trialx.com/clinical-trials/listings/318004/primary-individualized-evaluation-of-cardiovascular-events-in-patients-with-diabetes-mellitus-using-hemotag/?&radius=10&place=Minatoga&user_country=Japan

PRimary IndividualiZed Evaluation of Cardiovascular ...

This is a prospective, multi-center, longitudinal study to evaluate the proportion of cardiovascular events in diabetic mellitus patients identified by HEMOTAG ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11683709/

Diabetes Mellitus and Cardiovascular Disease

Extensive data collected from various studies have shown that strictly controlled BP potentially decreases the risk of CVD in diabetic patients compared to the ...

3.

policylab.us

policylab.us/clinical-trials/l/florida/west-palm-beach/diabetes

Diabetes Clinical Trials in West Palm Beach, FL - Policy Lab

PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG. NCT06567795. Recruiting. To evaluate the ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04874116

Decreasing Cardiovascular Risk for Patients With Diabetes

Cardiovascular disease (CVD) complications are the leading cause of diabetes mellitus (DM)-related morbidity and mortality, creating a significant burden on ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8668905/

Cardiovascular outcomes of type 2 diabetic patients treated ...

Cardiovascular events account for 70% of deaths in patients with type 2 diabetes mellitus ... data with regards to their longer-term effectiveness in this ...

6.

ahajournals.org

ahajournals.org/doi/10.1161/circ.152.suppl_3.4370321

Abstract 4370321: Non-invasive Hemodynamics for ...

Methods: Daily multi-channel recordings from the HEMOTAG device and electronic health records were analyzed for 56 diabetic patients.

7.

trialstoday.org

trialstoday.org/trial/NCT06567795

PRimary IndividualiZed Evaluation of Cardiovascular ...

Purpose. To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG. Conditions. Diabetes Mellitus Type 2 ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6460446/

Hemostatic Abnormality and Associated Factors in Diabetic ...

An overall hemostatic abnormality in diabetic patients was found to be high. The APTT and platelet count were lower in diabetic patients whilst the fibrinogen ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11264856/

A high-volume study on the impact of diabetes mellitus ...

This study provides an update on the impact of DM on clinical outcomes, including mortality, complications and reinterventions, using data on percutaneous and ...

10.

cardiab.biomedcentral.com

cardiab.biomedcentral.com/articles/10.1186/s12933-024-02424-7

Exploring the mortality and cardiovascular outcomes with ...

Our findings indicated a lower incidence of all-cause mortality and MACE after long-term follow-up, along with a higher likelihood of achieving dialysis-free ...