Type 1 Diabetes Education and Support Study

Type1diabetes Clinical Trial

— T1DES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05735340
• Other study ID #: RNG211852
• Secondary ID: 1R01DK128236-01A
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Kaiser Permanente
• Contact: Teaniese L Davis, PhD
• Phone: 404-337-3646
• Email: teaniese.l.davis[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 post-baseline 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

Inclusion Criteria:

• Kaiser Permanente Georgia Member

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Behavioral:
• Diabetes Education
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
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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Georgia	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	Emory University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Diabetes Distress	Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.	3 months
Primary	Diabetes Distress	Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.	6 months
Primary	A1C	Point of Care A1C	3 months
Primary	A1C	Point of Care A1C	6months