Mil Familias Cohort Establishment: a Study to Understand Determinants of Diabetes and Its Complications Among US Latinos

The vision of Mil Familias is to reduce the burden of cardio-metabolic disease among Latino
families in Santa Barbara County and beyond. The aim is to establish an observational cohort
of 1,000 Latino families, with at least one family member currently living with diabetes, in
order to understand better the impact of the 5 determinants of human health (genetics,
biology, behavior, psychology, and society/environment) in this population. Once the
1,000-family cohort is established, evidence-based intervention studies will be developed and
implemented based on new knowledge, with collaborators from the healthcare, public policy,
academic, pharmaceutical, medical device and technology industries. The strategy involves 4
coordinated and iterative components to achieve its mission:

1. Especialistas: Trusted, bilingual community health workers specially-trained in diabetes
education, clinical research methodologies, and care referral. The Especialistas will
engage directly with participants to conduct research activities, answer questions, and
when necessary, refer participants to appropriate, local community resources.

2. Data: Facilitated by Especialistas, each individual participant will contribute
information on up to 100 different variables relating to their genetics, biology,
psychology, behavior and society/environment, thus creating a one-of-a-kind database and
associated specimen biobank on Latino health and lifestyle ("Living Information Bank").

3. Interventions: Based on the data, evidence-based, collaborative, culturally-relevant
prevention and treatment strategies are planned to develop once the cohort of 1,000
families has been established.

4. Allies: This community-based participatory research study requires engagement from key
stakeholders from the Latino community, healthcare sectors, hospitals, payers,
businesses, people with diabetes and philanthropists. Organizations and individuals
support Mil Familias by contributing their resources, experiences, and skill-sets.

Inclusion Criteria:

1. Males or females ≥ 7 years of age at enrollment.

2. Self-reported Latino heritage.

3. 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.

4. Signed and dated written informed consent by the date of enrollment.

5. 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:

1. Life expectancy < 6 months.

2. Any active clinically significant physical or mental disease or disorder, which in the
investigator's opinion could interfere with the participation of the trial.

3. Language barriers precluding comprehension of study activities and informed consent.

4. Participation in other trials involving medication or device within 1 month prior to
enrollment.

5. Known or suspected abuse of alcohol, narcotics, or illicit drugs. -