Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R-2310-06383 | Other Grant/Funding Number | The Leona M. and Harry B. Helmsley Charitable Trust |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
| Emory University | OTHER |
| Grady Memorial Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes Education | Active Comparator | Participants in this arm will receive traditional diabetes education following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow up will be conducted at 3-months and 6-months. |
|
| T1DES | Experimental | Participants in this arm will receive a emotion regulation intervention called T1DES following a baseline assessment. During months 1-3, participants will attend 5 sessions. Follow-up will be conducted at 3-months and 6-months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Distress | 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 months |
| Diabetes Distress | Problem Areas in Diabetes - Emerging Adults 25 Item Measure and Scoring. Higher scores indicate more diabetes distress, with a range from 0 to 100. | 6 months |
| Diabetes Distress | Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6. | 3 months |
| Diabetes Distress | Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6. | 6 months |
| A1C | Point of Care A1C | 3 months |
| A1C | Point of Care A1C | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Teaniese L Davis, PhD | Kaiser Permanente Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health System | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41918050 | Derived | Davis TL, McCracken C, Fisher L, Graetz I, Barzilay J, Vellanki P, Haw JS, Gonzalez Paz L, Wolf R, Crawford M, Wright M, Bock F, Sekar S. Feasibility and signals of efficacy of the Type 1 Diabetes Education and Support (T1DES) intervention to improve diabetes distress and glycemic levels among Black young adults with type 1 diabetes compared to standard diabetes education: study protocol for a randomized pilot trial. Pilot Feasibility Stud. 2026 Apr 1;12(1):65. doi: 10.1186/s40814-026-01776-z. |
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2025 | May 18, 2026 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |