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Diabetes Education for Type 1 Diabetes (T1DES Trial)

N/A
Recruiting
Led By Teaniese L Davis, PhD, MPH
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6months
Awards & highlights

T1DES Trial Summary

This trial assesses the feasibility of a culturally tailored intervention to help Black young adults with Type 1 Diabetes better manage their condition.

Who is the study for?
This study is for Black young adults aged 18-30 with Type 1 diabetes, who have a Hemoglobin A1c level over 7.5, can read English, and are members of Kaiser Permanente Georgia or Grady Health Systems. They must be able to text and give informed consent. Those with severe diabetes complications or cognitive impairments that prevent informed consent cannot join.Check my eligibility
What is being tested?
The trial is testing T1DES, a culturally tailored educational support program designed to address diabetes distress among Black patients with Type 1 diabetes. It aims to see if this intervention improves their management of the condition compared to usual care.See study design
What are the potential side effects?
Since T1DES involves education and support rather than medication, there aren't typical drug side effects; however, participants may experience emotional discomfort discussing personal health issues during sessions.

T1DES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 30 years old.
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I have been diagnosed with Type 1 diabetes.

T1DES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A1C
Diabetes Distress

T1DES 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
55 Previous Clinical Trials
63,996 Total Patients Enrolled
Kaiser PermanenteLead Sponsor
537 Previous Clinical Trials
24,113,296 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,346 Previous Clinical Trials
4,314,368 Total Patients Enrolled

Media Library

Diabetes Education Clinical Trial Eligibility Overview. Trial Name: NCT05735340 — N/A
Type 1 Diabetes Research Study Groups: Diabetes Education, T1DES
Type 1 Diabetes Clinical Trial 2023: Diabetes Education Highlights & Side Effects. Trial Name: NCT05735340 — N/A
Diabetes Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT05735340 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participating in this research higher than twenty?

"The permissible age range for participation in this clinical trial is 18 to 30 years old as stated in the eligibility criteria."

Answered by AI

Is there currently a call for participants in this research endeavor?

"This study, which was first posted on March 1st 2023 and last edited on February 9th 2023, is no longer actively recruiting. Nevertheless, 1255 alternative medical studies are currently enrolling patients."

Answered by AI

How can I enlist in this exploration?

"This research is enrolling 40 individuals, aged 18 to 30 years old and having type 1 diabetes. Qualifying applicants must meet the following standards: Kaiser Permanente Georgia Member at time of enrollment, Hemoglobin A1c > 7.5 during sign up, own a cell phone that can transmit/receive text messages, identify as Black or African American ethnicity-wise, possess English literacy and be willing to give informed consent."

Answered by AI
~6 spots leftby Jun 2024