Expansion of the T1DES Pilot to a Public Hospital
Diabetes distress has been identified as one of the largest contributors to the racial disparity in glycemic control that disproportionately burdens Black patients ages 18-30 years with type 1 diabetes (T1D). In order to combat this issue, this study assesses the feasibility of the culturally tailored intervention T1DES and evaluates the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among Black young adults with T1D.
Conditions:
🦠 Type 1 Diabetes
🗓️ Study Start (Actual) 25 March 2024
🗓️ Primary Completion (Estimated) 1 February 2025
✅ Study Completion (Estimated) 30 April 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Grady Health System Patient
    • * Aged 18 - 30 years
    • * Confirmed diagnosis of Type 1 diabetes
    • * Hemoglobin A1c \> 7.5 at time of enrollment
    • * a cell phone able to send/receive text messages
    • * Self-reported race of Black or African American
    • * Ability to read in English and provide informed consent

    Exclusion Criteria:

    • * Developmental delay or other cognitive impairment that would render the participant unable to provide informed consent
    • * Subjects with visual impairment or have severe hearing or other physical disabilities that would be a barrier for participating in-group or web sessions
    • * Diabetes complications that would preclude participation in the study
Ages Eligible for Study: 18 Years to 30 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ 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 3 July 2024
  • First Submitted that Met QC Criteria 3 July 2024
  • First Posted 10 July 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 3 July 2024
  • Last Update Posted 10 July 2024
  • Last Verified July 2024