Mil Familias Cohort Establishment: a Study to Understand Determinants of Diabetes and Its Complic… (NCT03830840) | Clinical Trial Compass
CompletedNot Applicable
Mil Familias Cohort Establishment: a Study to Understand Determinants of Diabetes and Its Complications Among US Latinos
United States405 participantsStarted 2019-02-01
Plain-language summary
The Mil Familias Cohort Establishment involves enrolling 1000 Latino families with at least one member in the family having type 2 diabetes, including children and youth, and measuring the 5 determinants of human health: genetics, biology, behavior, psychology, and society/environment.
Who can participate
Age range
7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or females ≥ 7 years of age at enrollment.
. Self-reported Latino heritage.
. Co-resides with immediate family member (as defined above) OR self with established diagnosis of Type 2 Diabetes for at least one year prior to enrollment date.
. Signed and dated written informed consent by the date of enrollment.
. Based on the research staff's judgment, subject or subject's representative must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the wearable device portion.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Success (evaluated by Yes/No format) recruiting and establishing an observational cohort of 1,000 Latino families with at least one family member living with type 2 diabetes by deploying the methods proven feasible by Mil Familias Operational Pilot.
. Any active clinically significant physical or mental disease or disorder, which in the investigator's opinion could interfere with the participation of the trial.
. Language barriers precluding comprehension of study activities and informed consent.
. Participation in other trials involving medication or device within 1 month prior to enrollment.
. Known or suspected abuse of alcohol, narcotics, or illicit drugs. -