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Diabetes Self-Management for Type 2 Diabetes

N/A

Recruiting

Led By Cherlie Magny-Normilus, PhD

Research Sponsored by Boston College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-described Haitian immigrant aged 21 and older

Known diagnosis of type 2 diabetes for at least one year

Must not have

Unable to comprehend, consent and or fully participate in the study

Having a diagnosis of type 1 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up (t0) baseline through (t3) 90 days post-intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a diabetes self-management program for Haitian immigrants to see if it is effective.

Who is the study for?

This trial is for adult Haitian immigrants, aged 21 or older, who have been living in the US for at least a year and have had type 2 diabetes diagnosed for over a year with an HbA1c level of 7.5% or higher. Participants must be willing to engage in an interview. Those with type 1 diabetes or unable to fully participate are excluded.

What is being tested?

The study is testing the effectiveness of a new education program designed to help participants manage their type 2 diabetes better on their own. It's a pilot randomized study which means some people will receive the program while others may not, by chance.

What are the potential side effects?

Since this trial focuses on education and self-management behaviors rather than medication, there are no direct medical side effects expected from participating in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a Haitian immigrant and I am 21 years old or older.

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I have been diagnosed with type 2 diabetes for over a year.

Exclusion Criteria

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

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I am able to understand and agree to participate in the study.

Select...

I have been diagnosed with type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ (t0) baseline through (t3) 90 days post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~(t0) baseline through (t3) 90 days post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and (t0) baseline through (t3) 90 days post-intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro

Stanford Diabetes Self-Efficacy Scale (8- item)

Summary of Diabetes of Self-Care Activities Scale (11- item)

+1 more

Secondary study objectives

Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6

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: Diabetes Self-Management BehaviorsExperimental Treatment1 Intervention

Self-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks.

Group II: Usual Type 2 Diabetes CareActive Control1 Intervention

The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study.

0 / 4Eligibility criteria met