Effects of My Diabetes Care on Patient Outcomes
My Diabetes Care: A Pragmatic, Parallel-design, Randomized Controlled Trial
2 other identifiers
interventional
458
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jul 2023
Typical duration for not_applicable diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2022
CompletedStudy Start
First participant enrolled
July 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2025
CompletedNovember 13, 2025
November 1, 2025
2 years
July 1, 2022
November 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Blood Glucose Control
Hemoglobin A1c will assessed using mail-in home HbA1c test kits and participants' most recent hemoglobin A1C will be abstracted from participants' electronic medical record.
Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Secondary Outcomes (10)
Change in Body Mass Index (BMI)
Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Low Density Lipoprotein (LDL)
Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Urine Albumin-to-Creatinine Ratio
Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Blood Pressure Control
Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Diabetes Self-Care (General Diet Adherence)
Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
- +5 more secondary outcomes
Study Arms (2)
My Diabetes Care
EXPERIMENTALPatients have access to an existing patient web portal (i.e., Epic's MyChart) embedded with My Diabetes Care.
Usual Care
NO INTERVENTIONPatients will have access to an existing patient web portal (i.e., Epic's MyChart) NOT embedded with My Diabetes Care (i.e., usual care)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Type 2 Diabetes Mellitus
- Age 18-75 years old
- Currently taking at least one medication for diabetes
- Be a patient at Vanderbilt University Medical Center (VUMC) or Brigham and Women's Hospital (BWH)
- Able to speak and read in English or Spanish
- Have reliable access to a smartphone, tablet, or computer with internet access
- Active patient web portal account (My Health at Vanderbilt at VUMC or Patient Gateway at BWH)
You may not qualify if:
- Receiving dialysis,
- Pregnant or planning to become pregnant within the next year,
- Living in a long-term care facility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William Martinez, MD, MS
Vanderbilt University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
July 1, 2022
First Posted
July 11, 2022
Study Start
July 6, 2023
Primary Completion
July 14, 2025
Study Completion
July 14, 2025
Last Updated
November 13, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Deidentified individual participant data that underlie the results reported will be available after publication in a peer-reviewed journal and posted on clinical trials and ending after 36 months of publication.
- Access Criteria
- Researchers should provide a methodologically sound proposal to achieve their proposed aims. Proposals may be submitted to the principal investigator up to 36 months following publication. To gain access, data requestors will need to sign a data access agreement.
After study results are posted on clinical trials and published in a peer-reviewed journal, de-identified individual participant data that underlie the results reported will be available upon requests made to the principal investigator and ending after 36 months after publication.