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Uses the Hemotag device to track heart and vessel events in type 2 diabetes

Observes adults with type 2 diabetes using the Hemotag device for heart and vessel events.

Key facts

Who runs it
Aventusoft, LLC.
Where
West Palm Beach, United StatesSee the site
Trial code
Registry title
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
Status
Recruiting
People taking part
189 people, planned
Started
14 Mar 2024
Expected to end
18 Mar 2027
Type of study
Observational
Treatments tested
  • Hemotag
Record updated
23 August 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults over 40 with type 2 diabetes for at least 5 years who have heart or blood vessel disease, or diabetes complications plus other risk factors.

Age
Older than 40 years (minimum age 40 Years)
Sex
All sexes can join.
Disease stage
Type 2 diabetes for at least 5 years. Either cardiovascular disease (coronary artery, cerebrovascular or peripheral artery disease), or one diabetes complication (retinopathy, nephropathy, neuropathy or elevated hs-CRP) plus a history of two or more of: hypertension for at least 6 months, LDL-C >100 mg/dL (2.6 mmol/L), obesity (BMI ≥ 27 for men or ≥ 22 for women), smoking.
Biomarker or test result
Diabetic nephropathy means eGFR <60 mL/min/1.73m2 and/or urine albumin/creatinine ratio ≥30 mg/g. Elevated hs-CRP is one qualifying diagnosis.

Main reasons for not taking part

  • Terminal condition with life expectancy less than 12 months
  • Chest deformity or lesion, or skin problems, that prevent using the HEMOTAG
  • Taking part in another interventional study
  • Pregnant or planning pregnancy; women of childbearing potential unwilling to use contraception
  • Cannot give informed consent (must speak English), or impaired cognitive ability

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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 \&lt;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 \&gt;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 take part

  • Terminal condition with life expectancy less than 12 months as determined by investigator
  • 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)
  • Physical deformity in the chest area or lesion that may prevent proper HEMOTAG application or adjustment
  • 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\&#39;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

Where in United States

  • Metabolic Research Institute, IncWest Palm Beach, United StatesContact: Alayzah Garcia, BATaking people

About the trial

What the trial wants to find out

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

The group in the trial

  • 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.

    Treatment: Hemotag

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prospective, Multi-center, Longitudinal, Study for PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
Plain-language title
Uses the Hemotag device to track heart and vessel events in type 2 diabetesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 August 2024