Expansion of the T1DES Pilot to a Public Hospital

Last updated: March 7, 2025
Sponsor: Kaiser Permanente
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Diabetes Mellitus, Type 1

Treatment

T1DES

Diabetes Education

Clinical Study ID

NCT06494722
RNG212536
R-2310-06383
  • Ages 18-30
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Developmental delay or other cognitive impairment that would render the participantunable to provide informed consent

  • Subjects with visual impairment or have severe hearing or other physicaldisabilities that would be a barrier for participating in-group or web sessions

  • Diabetes complications that would preclude participation in the study

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: T1DES
Phase:
Study Start date:
March 25, 2024
Estimated Completion Date:
November 30, 2025

Study 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 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.

Connect with a study center

  • Grady Health System

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

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