← Back to Search

Diabetes Self-Management for Type 2 Diabetes

N/A

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston CollegeLead Sponsor

37 Previous Clinical Trials

47,279 Total Patients Enrolled

National Institute of Nursing Research (NINR)NIH

579 Previous Clinical Trials

10,376,342 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,539 Total Patients Enrolled

Media Library

Diabetes Self-Management Behaviors Clinical Trial Eligibility Overview. Trial Name: NCT04949568 — N/A

Type 2 Diabetes Research Study Groups: Usual Type 2 Diabetes Care, Diabetes Self-Management Behaviors

Type 2 Diabetes Clinical Trial 2023: Diabetes Self-Management Behaviors Highlights & Side Effects. Trial Name: NCT04949568 — N/A

Diabetes Self-Management Behaviors 2023 Treatment Timeline for Medical Study. Trial Name: NCT04949568 — N/A

Frequently Asked Questions

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

Does this research endeavor seek to enroll adults over the age of 20?

"This clinical trial necessitates that applicants be between 18 to 90 years of age. For those under the legal age, there are 199 other trials available. Additionally, for patients aged 65 and over, 1127 medical studies exist."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes

Cherlie Magny-Normilus 2023. "Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04949568.

All > Diabetes Type 2 > Type 2 Diabetes