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Completed

NCT Number: NCT06494722

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grady Health System

Atlanta, Georgia, 30303, United States

About this study

This research focuses on the unique needs of Black young adults aged 18-30 years to address a critical gap in the research and clinical care. The goal is to test the feasibility and preliminary efficacy of a culturally adapted and tailored intervention to enhance diabetes management strategies among Black young adults with T1D, addressing the pervasive racial disparity in health outcomes for this population.

The specific aims for this study are to:

Aim 1: Assess feasibility of the culturally tailored intervention T1DES by measuring intervention acceptability, demand (retention, completed > 80% of sessions), practicality, and implementation fidelity through participant surveys and key informant interviews with participants and the health care delivery team.

Aim 2: Evaluate the effect of the T1DES intervention on diabetes outcomes in a pilot randomized clinical trial among N=40 Black young adults age 18-30 years with T1D and elevated HbA1c (>7.5%) by comparing changes in HbA1c, diabetes distress, and self-management from baseline to 6-months postbaseline among participants randomized to T1DES compared to the diabetes education-only control condition.

The goal of this study is to provide diabetes education and emotion regulation support tailored for Black young adults' experiences that will result in sustained glycemic control and can be incorporated into adult endocrinology practices.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes education

Behavioral

Participants in this arm will receive traditional diabetes education over 5 sessions in the first 3 months of participation and be followed for 6 months.

T1DES

Behavioral

Participants in this arm will receive the T1DES behavioral interventions over 5 sessions in the first 3 months of participation and be followed for 6 months.

Primary outcomes

  1. Diabetes Distress

    Time frame: 3 months

    Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.

  2. Diabetes Distress

    Time frame: 6 months

    Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100.

  3. Diabetes Distress

    Time frame: 3 months

    Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.

  4. Diabetes Distress

    Time frame: 6 months

    Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.

  5. A1C

    Time frame: 3 months

    Point of Care A1C

  6. A1C

    Time frame: 6 months

    Point of Care A1C

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Emory University
  • Grady Memorial Hospital
  • The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Official study title

Evaluating the Feasibility of Type 1 Diabetes Education and Support (T1DES) Intervention to Improve Diabetes Distress Among Black Young Adults

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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