NCT06494722

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

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

March 11, 2025

Status Verified

July 1, 2024

Enrollment Period

1.4 years

First QC Date

July 3, 2024

Last Update Submit

March 7, 2025

Conditions

Type 1 Diabetes

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

    6 months

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 VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

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)

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Teaniese L Davis, PhD

    Kaiser Permanente Georgia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teaniese L Davis, PhD

CONTACT

404-337-3646teaniese.l.davis@kp.org

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

July 3, 2024

First Posted

July 10, 2024

Study Start

March 25, 2024

Primary Completion

August 1, 2025

Study Completion

November 30, 2025

Last Updated

March 11, 2025

Record last verified: 2024-07

Locations

US(1)