Type 1 Diabetes Education and Support Study

Not Applicable

Recruiting

• Conditions: Type1diabetes
• Interventions: Behavioral: Diabetes Education; Behavioral: T1DES

• Registration Number: NCT05735340
• Lead Sponsor: Kaiser Permanente

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Study Start: 2023-04-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-06
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetes Education	Diabetes Education	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	T1DES	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.

Primary Outcome Measures

Name	Time	Method
A1C	6months	Point of Care A1C
Diabetes Distress	6 months	Type 1 Diabetes Distress Scale. Higher scores indicate more diabetes distress, with a range from 1 to 6.

Trial Locations

Locations (1)

Kaiser Permanente Georgia; 🇺🇸 Atlanta, Georgia, United States