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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

Must not have

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 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My diabetes complications won't stop me from joining the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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.

0 / 3Eligibility criteria met