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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).
Conditions:
🦠 Type 2 Diabetes 🦠 Glycemic Control 🦠 Psychological Distress
🗓️ Study Start (Actual) 27 February 2023
🗓️ Primary Completion (Estimated) March 2025
✅ Study Completion (Estimated) September 2025
👥 Enrollment (Estimated) 400
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chula Vista, California, United States

📋 Eligibility Criteria

Description

    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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 15 September 2022
  • First Submitted that Met QC Criteria 4 October 2022
  • First Posted 7 October 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 May 2024
  • Last Update Posted 7 May 2024
  • Last Verified May 2024
I'm interested ...!!