Diabetes Mellitus Type 2PRIZETAGNCT06567795
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
An observational study of Diabetes Mellitus Type 2 and Cardiovascular Diseases, run by Aventusoft, LLC. at 1 site in United States.
Trial summary
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2, Cardiovascular Diseases, Coronary Artery Disease
- What is being tested?
- Hemotag
- Type of treatment
- Medical device
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2024to 18 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patients that meet inclusion exclusion criteria
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Metabolic Research Institute, Inc
West Palm Beach, Florida, 33401'
Alayzah Garcia, BA, 561-802-3060 ext. 8032, agarcia@metabolic-institute.com
Barry Horowitz, MD
About this study
Official title: Prospective, Multi-center, Longitudinal, Study for PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
To evaluate the proportion of diabetic mellitus patients with CV events as measured by HEMOTAG.
Read the 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.
- Conditions
- Diabetes Mellitus Type 2, Cardiovascular Diseases, Coronary Artery Disease, Cerebrovascular Disease, Peripheral Artery Disease
- Being tested
- Hemotag
- Keywords
- Diabetes Mellitus, Cardiovascular Diseases, Coronary Artery Disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Coronary Artery Disease, Cerebrovascular Disorders, Peripheral Arterial Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemotagDevice
Hemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days
| Study group | Role | What they receive |
|---|---|---|
| HEMOTAG with Standard of Care in DM patients | 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. Receives: Device: Hemotag |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration.
The primary endpoint will be to evaluate CV events measured by a composite endpoint defined by unplanned hospitalizations, emergency room visits/urgent care visits (that do not result in hospitalization), for cardiovascular events or death within the observation period of 12 months.
Measured: 12 months
Secondary outcomes (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.
Composite endpoint consisting of unplanned hospitalizations, emergency room visits/urgent care visits (that do not result in hospitalization), for cardiovascular events or death within the observation period of 6 months.
Measured: 6 months
Correlation of AO and CE at 6 and 12 months
Correlation of AO and CE at 6 and 12 months
Measured: 12 months
Correlation of CTI and CE at 6 and 12 months
Correlation of CTI and CE at 6 and 12 months
Measured: 12 months
All Deaths for 12 months
All Deaths for 12 months
Measured: 12 months
Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months
Median time to composite of worsening left ventricular dysfunction or heart failure among diabetic patients at 6 months and 12 months
Measured: 12 months
Six Minute Walk Test (Borg Dyspnea/Borg Fatigue Scale)
Six Minute Walk Test (Borg Dyspnea/Borg Fatigue Scale) Excellent: Distance is typically above 700 meters. Good: Distances within the average range between 400 and 700 meters Poor: Distances below the average range, indicating potential limitations in aerobic capacity and functional status is below 400 meters.
Measured: 12 months
Median time to heart failure at 6 and 12 months
Median time to heart failure at 6 and 12 months
Measured: 12 months
Median time to Left Ventricular Dysfunction at 6 and 12 months
Median time to Left Ventricular Dysfunction at 6 and 12 months
Measured: 12 months
Health State as measured by the EQ5D5L ( EuroQol 5 Dimensions 5 Levels)
Health State as measured by the EQ5D5L: 1 is the best possible value (indicating no problems), and 5 is the worst (indicating extreme problems).
- indicates no problems
- indicates slight problems
- indicates moderate problems
- indicates severe problems
- indicates extreme problems
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start14 Mar 2024
- Primary completion18 Mar 2026 (estimated)
- Study completion18 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aventusoft, LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567795
- Sponsor's protocol ID
- HT-101-VV-032
- Other IDs
- R44HL149561-03
- Acronym
- PRIZETAG
- Status last verified
- Aug 2024
- First submitted
- 21 May 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Longitudinal, Study for PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
- ClinicalTrials.gov ID
- NCT06567795
- Acronym / sponsor ID
- PRIZETAG / HT-101-VV-032
- Conditions
- Diabetes Mellitus Type 2, Cardiovascular Diseases, Coronary Artery Disease, Cerebrovascular Disease, Peripheral Artery Disease
- Keywords
- Diabetes Mellitus, Cardiovascular Diseases, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 189 participants (estimated)
- Lead sponsor
- Aventusoft, LLC.Industry (pharma, biotech, devices)
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 18 Mar 2026 (estimated)
- Study completion
- 18 Mar 2027 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HEMOTAG with Standard of Care in DM patients | – | Device: HemotagHEMOTAG 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 may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patients that meet inclusion exclusion criteria
Key inclusion criteria (18 listed)
- 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--
- Willingness to undergo HEMOTAG evaluation.
- Willingness to undergo Standard of Care visits/assessments and NT-pro BNP lab evaluations.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemotagHemotag non-invasive medical device is used to see cardiac function for DM2 patients at-home for 30 days | Device | HEMOTAG with Standard of Care in DM patients |
Primary outcome
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
The primary endpoint will be to evaluate CV events measured by a composite endpoint defined by unplanned hospitalizations, emergency room visits/urgent care visits (that do not result in hospitalization), for cardiovascular events or death within the observation period of 12 months.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2 and Cardiovascular Diseases, run by Aventusoft, LLC. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CINDY KOBER, BS (954-399-3335, cindy@aventusoft.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.