NCT05735340

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 15, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2026

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2.8 years

First QC Date

January 30, 2023

Last Update Submit

May 5, 2026

Conditions

Type1diabetes

Keywords

diabetestype 1

Outcome Measures

Primary Outcomes (6)

  • 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

    6months

Study Arms (2)

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.

Behavioral: Diabetes Education

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.

Behavioral: T1DES

Interventions

Diabetes EducationBEHAVIORAL

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.

Diabetes Education
T1DESBEHAVIORAL

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.

T1DES

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Georgia

Atlanta, Georgia, 30309, United States

Location

Related Publications (1)

  • 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. doi: 10.1186/s40814-026-01776-z. Online ahead of print.

    PMID: 41918050BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Teaniese L Davis, PhD, MPH

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 21, 2023

Study Start

April 15, 2023

Primary Completion

February 6, 2026

Study Completion

February 6, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)