NCT05451914

Effects of My Diabetes Care on Patient Outcomes

My Diabetes Care: A Pragmatic, Parallel-design, Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 458 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to conduct a two-arm, parallel-design, pragmatic randomized controlled trial of a patient portal intervention for diabetes, My Diabetes Care (MDC), to evaluate its effect on clinical outcomes.

Detailed description

484 adult patients with type 2 diabetes mellitus will be randomized to one of two arms. 242 will be assigned to the intervention (My Diabetes Care) embedded within an existing patient web portal, My Health at Vanderbilt at Vanderbilt University Medical Center or Patient Gateway at Brigham and Women's Hospital. 242 will be assigned to a usual care comparison arm with access currently available version of My Health at Vanderbilt or Patient Gateway without the My Diabetes Care (MDC) application. Potentially eligible patients will be invited to be screened for enrollment in the study. Interested patients will be able to complete an electronic consent form and enroll online via Research Electronic Data Capture (REDCap). Outcomes data will be collected from patients at four time points: baseline (T0), three-month follow-up (T1), three-month follow-up (T2), six-month follow-up (T3), and twelve-month follow-up (T4). At each time point, study participants will complete questionnaires electronically via email using REDCap, participants' hemoglobin A1C level will be assess via home A1C test kits, and participants' diabetes health data will be abstracted from their electronic health record. Participants will be randomized to the intervention or control arm after their baseline data is collected.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
OTHER	My Diabetes Care	My Diabetes Care (MDC) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL) and provides literacy level-appropriate and tailored diabetes self-care information.

Timeline

• Start date: 2023-07-06
• Primary completion: 2025-07-14
• Completion: 2025-07-14
• First posted: 2022-07-11
• Last updated: 2025-11-13

Locations

2 sites across 1 country: United States