Observational Study of HEMOTAG for Cardiovascular Events in Type 2 Diabetes
This study is looking at how a non-invasive medical device called HEMOTAG can help identify heart-related problems (cardiovascular events) in people with Type 2 Diabetes. If you are over 40, have had Type 2 Diabetes for at least 5 years, and also have existing cardiovascular disease or certain other medical conditions, you might be able to join. The study aims to see what percentage of diabetic patients experience cardiovascular events as detected by HEMOTAG over a 12-month period. The current status of the study is unclear, and it plans to enroll 189 participants.
- Study design
- This is an observational study that will follow 189 participants over time to see how many experience cardiovascular events as measured by the HEMOTAG device.
- What's involved
- You would use the HEMOTAG device at home for 30 days after your initial visit, and again after 6 months, and after any hospitalizations for heart events. You will also have standard clinic visits at 6 and 12 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months to evaluate the proportion of cardiovascular events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
PRimary IndividualiZed Evaluation of Cardiovascular Events in Patients With Diabetes Mellitus Using hemoTAG
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- To evaluate the proportion of diabetic mellitus patients with cardiovascular events as identified by HEMOTAG measurements over a 12 month duration.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.