Diabetes Education for Diabetes

(MCPILOTDSMES Trial)

DB
Overseen ByDashauna Ballard, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS Consulting, a local independent pharmacy and wellness center, at a local faith-based organization. DSMES sessions meet twice a month and typically address topics including physical activity, nutrition, coping, and reducing risk and complications. Prior to beginning the program, participants will complete a questionnaire that assesses diabetes self-management behaviors (such as diet, physical activity, and medication adherence) and diabetes knowledge. Additionally, they will participate in a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected. This data will also be collected again after the completion of the program. In this program, participants will be assigned a community health worker who will contact them outside of scheduled DSMES sessions to provide support. Participants will also be randomly assigned to one of two cohorts, the Traditional cohort and the Remote Patient Monitoring (RPM) cohort. The traditional cohort will use paper trackers to track blood pressure and blood sugar outside of DSMES sessions while the RPM cohort will utilize an RPM platform to track this data.

Who Is on the Research Team?

BH

Bertha Hidalgo, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with diabetes or prediabetes.
I am 18 years old or older.
* Live in Jefferson County, Alabama
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Biometric Screening

Participants complete a biometric screening where clinical data such as blood A1C, blood pressure, blood cholesterol, and BMI are collected

1 week
1 visit (in-person)

Treatment

Participants engage in a 3-month DSMES program with sessions twice a month, addressing topics like physical activity, nutrition, coping, and reducing risk and complications

12 weeks
6 visits (in-person)

Follow-up

Participants are monitored for changes in clinical data and diabetes self-management behaviors after the program

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Remote Patient Monitoring in a Faith-Based Program
  • Traditional Cohort Faith-based DSMES program

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Remote Patient Monitoring (RPM) CohortExperimental Treatment1 Intervention
Group II: Traditional CohortActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials
473
Recruited
1,374,000+