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Behavioral Intervention
Diabetes Education for Type 1 Diabetes
N/A
Recruiting
Led By Teaniese L Davis, PhD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 18 - 30 years
Confirmed diagnosis of Type 1 diabetes
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help Black young adults with type 1 diabetes by testing a specialized program called T1DES. The program is designed to address the emotional stress related to diabetes and how it impacts blood
Who is the study for?
This trial is for Black patients aged 18-30 with Type 1 Diabetes, who are Grady Health System patients, have a Hemoglobin A1c > 7.5, and can text on a cell phone. They must be able to read English and consent to the study. It excludes those with cognitive impairments or severe physical disabilities that hinder participation.
What is being tested?
The study tests T1DES, a culturally tailored intervention designed to reduce diabetes distress among young Black adults with Type 1 Diabetes. The goal is to see if it improves their diabetes management compared to standard diabetes education.
What are the potential side effects?
Since this trial focuses on educational interventions rather than medications, there may not be direct side effects like those seen in drug trials; however, participants might experience emotional or psychological responses related to the content of the education sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 30 years old.
Select...
I have been diagnosed with Type 1 diabetes.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a visual, hearing, or physical disability that makes it hard for me to join group or web sessions.
Select...
I do not have severe diabetes complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
A1C
Diabetes Distress
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: T1DESExperimental Treatment1 Intervention
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.
Group II: Diabetes EducationActive Control1 Intervention
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.
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Who is running the clinical trial?
The Leona M. and Harry B. Helmsley Charitable TrustOTHER
65 Previous Clinical Trials
99,525 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
552 Previous Clinical Trials
27,731,582 Total Patients Enrolled
Emory UniversityOTHER
1,700 Previous Clinical Trials
2,604,558 Total Patients Enrolled
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