Recruiting

Latinos Understanding the Need for Adherence in Diabetes Using E-Health

Latinos Understanding the Need for Adherence in Diabetes using Care Coordination, Integrated Medical and Behavioral Care and E-Health (LUNA-E) is a randomized controlled trial (RCT) that will test the effectiveness a patient-centered, team-based, primary care intervention with E-Health enhancements in improving glycemic control (primary outcome, hemoglobin A1C level) and psychological distress (secondary outcome; depression, anxiety symptoms).

ClinicalTrials.gov IDNCT05570734

PhaseNA

Enrollment400

SponsorSan Diego State University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes, Glycemic Control, Psychological Distress

About this study

Interventions

Behavioral: LUNA Care Coordination — Participants in this group will have 6 or more 30-minute care coordination sessions with the LUNA Care Coordinator. The LUNA Care Coordinator will assist with appointments and referrals, medications, and assist with accessing the health education videos. They will work closely with the participant's primary care provider and the LUNA Behavioral Health Provider.
Behavioral: LUNA Behavioral Health — Participants in this group will have 6 or more 30-minute behavioral health sessions with the LUNA Behavioral Health Provider. The LUNA Behavioral Health Provider will screen and address life stressors, social support, and health care use. The purpose of these sessions is to check on participant's progress with their care plan. The behavioral health sessions will involve discussion of issues that may interfere with optimal diabetes self-management. The LUNA Behavioral Health Provider will help participants overcome any potential barriers to managing their diabetes by setting goals and helping to address life stress or other issues that may be interfering with their diabetes self-management.
Behavioral: Health Education Videos — Participants in this group will have access to eight 20 to 30-minute health education video sessions with corresponding print material and activities to reinforce what they learn. The health education videos focus on medication adherence, self-monitoring, stress and coping, nutrition, physical activity and culturally driven beliefs and values.
Behavioral: Virtual Integrated Visits — Participants in this group will have two virtual integrated visits with the LUNA care team. Through video conferencing, they will meet at the same time with the LUNA Care Coordinator, the LUNA Behavioral Health Provider, and their primary care provider to ensure an integrated care plan.

Primary outcomes

Hemoglobin A1C (HbA1c) Blood Value (6-months post randomization)
Psychological Distress - Depression (6-months post randomization)
Psychological Distress - Anxiety (6-months post randomization)

Eligibility information

Inclusion Criteria: 1. Self identify as Hispanic/Latino ethnicity of any race 2. Registered patient of federally qualified health center 3. 18 years of age or older 4. Type 2 diabetes with hemoglobin A1C (HbA1c) \>7.5% in past 90 days 5. Approval from primary care provider 6. Not currently enrolled/participating in any other diabetes intervention program(s) Exclusion Criteria: 1. Actively being treated for cancer or Parkinson's Disease 2. Pregnant or nursing (temporary exclusion, may qualify 6-months postpartum) 3. Have plans to move out of the area in the next 12 months 4. Have other existing mental or physical health problems so severe as to prohibit informed consent and participation 5. Have severe diabetes complications (e.g., renal disease, or on dialysis)

Study locations

South Bay Latino Research Center, Chula Vista, California 91910 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.