Diabetes Mellitus, Type 2NCT05451914
Effects of My Diabetes Care on Patient Outcomes
A study testing My Diabetes Care in people with Diabetes Mellitus, Type 2, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- My Diabetes Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jul 2023to 14 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Receiving dialysis,
- Pregnant or planning to become pregnant within the next year,
- Living in a long-term care facility.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: My Diabetes Care: A Pragmatic, Parallel-design, Randomized Controlled Trial
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.
Read the 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
- Being tested
- My Diabetes Care
- Keywords
- Diabetes, Patient Web Portals, Health Information Technology
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Diabetes CareOther
Also called Patient-facing Diabetes Dashboard
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.
| Study group | Role | What they receive |
|---|---|---|
| My Diabetes Care | Experimental | Patients have access to an existing patient web portal (i.e., Epic's MyChart) embedded with My Diabetes Care. Receives: Other: My Diabetes Care |
| Usual Care | No intervention | Patients will have access to an existing patient web portal (i.e., Epic's MyChart) NOT embedded with My Diabetes Care (i.e., usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Participants' most recent body mass index (BMI) measurement will be abstracted from participants' electronic medical record.
Measured: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Low Density Lipoprotein (LDL)
Participants' most recent low density lipoprotein (LDL) measurement will be abstracted from participants' electronic medical record.
Measured: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Urine Albumin-to-Creatinine Ratio
Participants' most albumin-to-creatinine ratio will be abstracted from participants' electronic medical record.
Measured: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Blood Pressure Control
Participants' most recent blood pressure measurement will be abstracted from participants' electronic medical record and will be used to calculate the participants' mean arterial pressure (MAP) using the following formula: MAP = diastolic pressure + 1/3(systolic pressure - diastolic pressure).
Measured: 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)
The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess general diet adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. An example item includes "How many of the last SEVEN DAYS have you followed a healthful eating plan?" The general diet subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).
Measured: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Diabetes Self-Care (Exercise Adherence)
The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The exercise subscale is used to assess exercise adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. An example item includes "On how many of the last SEVEN DAYS did you participate in at least 30 minutes of physical activity?" The exercise subscale score is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).
Measured: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Diabetes Self-Care (Diabetes Medication Adherence)
The Adherence to Refills and Medications Scale-Diabetes (ARMS-D) is a reliable and valid measure of diabetes medication adherence. The 11-item ARMS-D has good internal consistency reliability (α=0.86). Responses range from 1="none of the time" to 4="all of the time," and are summed to produce an overall adherence score ranging from 12-48, with higher scores representing more problems with medication adherence.
Measured: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)
The Summary of Diabetes Self-Care Activity (SDSCA) is a 10-item multidimensional instrument to assess levels of diabetes self-care across five domains: general diet (2 items), specific diet (2 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess self-monitoring of blood glucose adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. An example item includes "On how many of the last SEVEN DAYS did you test your blood sugar?" The blood-glucose testing subscale is the mean number of days for the 2 items in the subscale. The score range is from 0 days (worst) to 7 days (best).
Measured: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Usability of MyChart (for Control Group)
The usability of the patient portal (Epic's MyChart) will be assessed using the System Usability Scale (SUS). The SUS is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability.
Measured: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Satisfaction/Usability of My Diabetes Care (for Intervention Group)
The usability of the My Diabetes Care will be assessed using the System Usability Scale (SUS). The SUS is a valid measure of usability and assesses users' perceptions of ease of use, likability of the interface, and overall satisfaction using a 5- point Likert scale (strongly disagree to strongly agree). The ten items are scored on a five-point Likert scale. The item scores are summed and then converted to a score ranging from 0 (worst) to 100 (best). Based on prior research, a score above 68 would be above average and a score of 85 or above suggests excellent usability.
Measured: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start6 Jul 2023
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, William Martinez, MD, MS, Vanderbilt University Medical Center
- Investigators
- William Martinez, MD, MS, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451914
- Sponsor's protocol ID
- 230106
- Other IDs
- R01DK131129
- Status last verified
- Nov 2025
- First submitted
- 1 Jul 2022
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Diabetes Care: A Pragmatic, Parallel-design, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05451914
- Acronym / sponsor ID
- 230106
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Patient Web Portals, Health Information Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| My Diabetes Care | Experimental | Other: My Diabetes CarePatients have access to an existing patient web portal (i.e., Epic's MyChart) embedded with My Diabetes Care. |
| Usual Care | No intervention | –Patients will have access to an existing patient web portal (i.e., Epic's MyChart) NOT embedded with My Diabetes Care (i.e., usual care) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Receiving dialysis,
- Pregnant or planning to become pregnant within the next year,
- Living in a long-term care facility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Diabetes CareAlso: Patient-facing Diabetes DashboardMy 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. | Other | My Diabetes Care |
Primary outcome
Change in Blood Glucose Control
Time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
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.
10 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Low Density Lipoprotein (LDL)
Time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Urine Albumin-to-Creatinine Ratio
Time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Blood Pressure Control
Time frame: 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)
Time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Diabetes Self-Care (Exercise Adherence)
Time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Diabetes Self-Care (Diabetes Medication Adherence)
Time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Change in Diabetes Self-Care (Self-Monitoring of Blood Glucose Adherence)
Time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Usability of MyChart (for Control Group)
Time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Satisfaction/Usability of My Diabetes Care (for Intervention Group)
Time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Martinez, MD, MS principal investigator
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Diabetes Care in people with Diabetes Mellitus, Type 2, run by Vanderbilt University Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Blood Glucose Control (time frame: Baseline (T0), Three-month Follow-up (T1), Six-month Follow-Up (T2), Twelve-month Follow-up (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.