Technology Delivered Diabetes-Modified Behavioral Activation Treatment

Diabetes Mellitus is highly prevalent in the United States (CDC 2014) and African Americans
(AA) are disproportionately affected and have higher prevalence, poorer metabolic control and
greater risk for complications and death compared to White Americans. Evidence from the
literature show that effective interventions for AAs with Type 2 Diabetes Mellitus (T2DM)
have multiple components including: education and skills training, nurse case management, and
maintain high intensity. However, few large Randomized Clinical Trials (RCT) have tested
multi-component interventions that include these key components in AAs with T2DM.

Behavioral Activation is a psychotherapeutic process whereby patients are encouraged to
identify and schedule structured and enjoyable activities for behavior change that are likely
to improve outcomes such as mood, behaviors and quality of life. A brief manualized
behavioral activation treatment for depression (BATD), has been modified for diabetes.

This study tests a multi-component, high intensity intervention that incorporates several
strategies that have been shown to be effective in improving diabetes outcomes in AAs. Nurse
case managers will use videoconferencing technology to deliver education, skills training and
problem solving for diabetes via smartphones, an approach that has not been used previously
in vulnerable and underserved ethnic minority populations.

Inclusion Criteria:

- Age ≥21 years

- Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit;

- Self-identified as AA

- Subject must be willing to use the FORA monitoring system for 6 months

- Subject must be willing to use the study assigned smartphone including
videoconferencing, lifestyle monitoring and medication monitoring apps for 6 months

- Subjects must be able to communicate in English

- Subjects must have access to a landline or Ethernet for FORA data uploads for the
study period.

Exclusion Criteria:

- Mental confusion on interview suggesting significant dementia

- Participation in other diabetes clinical trials

- Alcohol or drug abuse/dependency

- Active psychosis or acute mental disorder

- Life expectancy <6 months.