30 Participants NeededMy employer runs this trial

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?

This trial aims to help people with diabetes better manage their condition through education and support. Participants will join a 3-month program focusing on exercise, healthy eating, and stress management. The trial will compare two groups: one using paper logs for tracking health data and another using a digital platform for remote patient monitoring in a faith-based program. Individuals with diabetes or prediabetes living in Jefferson County, Alabama, might be a good fit, especially if they have never joined a similar education program before. As an unphased trial, this study offers a unique opportunity to gain valuable support and education to improve diabetes management.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on education and monitoring rather than changing your medication regimen.

What prior data suggests that this diabetes education program is safe?

Research has shown that remote patient monitoring (RPM) for diabetes is safe and generally easy for patients to use. Studies have found that RPM helps people manage their diabetes better without causing major safety problems. For instance, one study showed that RPM made it easier for 2,000 patients to track their blood sugar levels and other important health signs. Another review found that RPM helped patients stay safe and take their medications as prescribed.

Overall, evidence suggests that using technology to monitor health from home safely aids in managing diabetes.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage diabetes through education and monitoring. The Remote Patient Monitoring (RPM) approach is unique because it uses technology to track blood pressure and glucose levels remotely, offering real-time data and potentially faster intervention. This is different from traditional methods, which rely on paper trackers and less immediate feedback. By integrating these techniques into a faith-based setting, the trial aims to enhance patient engagement and accessibility, which could lead to better overall management of diabetes.

What evidence suggests that this trial's treatments could be effective for diabetes?

Research has shown that Diabetes Self-Management Education and Support (DSMES) programs can help people with diabetes improve their health. One study found that DSMES can lower HbA1c levels, which measure blood sugar control, by an average of 0.37% in 3-6 months. Another study found similar improvements, with these benefits lasting up to a year. DSMES is also linked to better diabetes outcomes, such as a lower risk of complications and improved overall health. This trial will compare two approaches: the Traditional Cohort, which uses paper trackers, and the Remote Patient Monitoring (RPM) Cohort, which uses a remote monitoring platform. This evidence suggests that joining a DSMES program could be helpful for managing diabetes effectively.678910

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?

This trial is for adults (18+) living in Jefferson County, Alabama, who have been diagnosed with diabetes or prediabetes and have never taken part in a diabetes self-management education program before.

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

Trial Overview

The study compares two ways of supporting people with diabetes: one group uses paper trackers to monitor their health, while the other uses remote patient monitoring technology. Both groups attend educational sessions at local faith-based organizations over three months.

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+

Citations

Effectiveness-Implementation Trial Comparing a Family Model ...

A comparative effectiveness trial comparing Standard-DSMES with Family-DSMES on outcomes for PWDs and family members, and detail our mixed-methods ...

Comparative effectiveness of telehealth-delivered family ...

DSMES provides guidance on several aspects of diabetes care, including healthy eating, being active, glucose monitoring, understanding blood glucose, taking ...

Empowering Faith-based Communities to Provide ...

In this study, individuals living with diabetes in the Birmingham area will participate in a free, 3-month DSMES program hosted by MedsPLUS ...

Diabetes Self-Management Education and Support Models ...

(2024), which showed that online DSMES interventions reduced HbA1c by an average of −0.37% (95% CI: −0.52 to −0.21) over 3–6 months, as well as ...

Comparative effectiveness of diabetes self-management ...

A DSMES program in Texas reported statistically significant reductions in A1c levels at 3 months that were sustained at 6-, 9- and 12-month follow-up ...

Diabetes Management Through Remote Patient Monitoring

Remote patient monitoring (RPM), defined as “the recording and transmission of patient biometrics, vital signs and/or disease-related data to a ...

Examining a Remote Patient Monitoring Program with ... - PMC

Remote patient monitoring (RPM) allows patients with specific chronic conditions to monitor and report their healthcare data through a digital ...

A systematic review of the impacts of remote patient ...

RPM interventions demonstrated positive outcomes in patient safety and adherence. RPM interventions also improved patients' mobility and ...

Remote patient monitoring (RPM) for diabetes management

Clinical quality and safety outcomes ... Research: “Livongo studies leverage proprietary data and remote monitoring to reveal unique diabetes management insights”.

Remote Patient Monitoring With Continuous Glucose ...

Integrating RPM with CGM has emerged as a promising strategy to improve diabetes management by facilitating frequent glucose monitoring and timely clinical ...