Diabetes Mellitus, Type 2NCT05448105
My Diabetes Care: A Scalability and Usability Study
A study testing My Diabetes Care (MDC) 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 prospective, longitudinal study on the My Diabetes Care (MDC) mobile intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial. 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 (MDC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Dec 2022to 22 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient at a participating clinic within Vanderbilt Medical Center or Brigham and Women's Hospital
- Able to speak and read in English or Spanish
- Reliable access to a smartphone or tablet with internet access
- Active patient web portal account (for example, My Health at Vanderbilt or Patient Gateway)
Who cannot join
- Have a medical condition that affects your memory or ability to think
- Have severe difficulty seeing or hearing
- Have a medical condition that makes it hard for people to understand what you are saying
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
The purpose of this study is to conduct a prospective, longitudinal study on the My Diabetes Care (MDC) mobile intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.
Read the detailed description
Up to 90 adult patients with type 2 diabetes mellitus will be enrolled and given access to My Diabetes Care (MDC). 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 selfcare information. Patients will be invited by mail 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) version 5.0.8. Study participants will complete questionnaires electronically via email using REDCap at two time points: baseline (T0) and one-month follow-up (T1). Participants will complete a baseline questionnaire (T0) including basic demographic questions, items about computer usage and internet access, and validated measures of health literacy and eHealth literacy. Each participant will have access to MDC for 1 month.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- My Diabetes Care (MDC)
- Keywords
- Diabetes Mellitus, Self-efficacy, Patient Web Portals
- 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 Care (MDC)Other
Also called Patient-facing Diabetes Dashboard
My Diabetes Care (MDC) is a multi-faceted patient portal intervention 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 diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency.
| Study group | Role | What they receive |
|---|---|---|
| My Diabetes Care (MDC) | Experimental | Patients have access to a patient web portal embedded with the My Diabetes Care (MDC) intervention. Receives: Other: My Diabetes Care (MDC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
The System Usability Scale (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 71 or above suggests 'good' usability.
Measured: One month follow-up (t1)
System Usage
System usage will be assessed by user analytics data capturing participant use to MDC during the study period. MDC use is defined as one or more visits to the MDC site during the study period.
Measured: One month follow-up (t1)
User Experience - Acceptance
User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). Survey items will assess agreement on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Participants will be asked whether they would continue to use My Diabetes Care (MDC) going forward were it to remain available and whether they would recommend MDC to other patients with diabetes.
Measured: One month follow-up (t1)
Secondary outcomes (9)
Change in Diabetes Knowledge
The Revised Brief Diabetes Knowledge Test (DKT2) is a valid measure of diabetes knowledge. The 14-item questionnaire was designed to assess a patient's understanding of diabetes management. The DKT2 is a uni-dimensional, 14-item scale with scores ranging from 0 to 14 (number of items answered correctly). Higher scores indicate greater knowledge.
Measured: Baseline (t0) to one month follow-up (t1)
Change in Diabetes Self-Care - 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: diet (4 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The general diet subscale is used to assess 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) to one month follow-up (t1)
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: diet (4 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. 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) to one month follow-up (t1)
Change in Diabetes Self-Care - Glucose Self-monitoring 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: diet (4 items), exercise (2 items), foot care (2 items), and blood-glucose testing (2 items). The blood-glucose testing subscale is used to assess glucose self-monitoring adherence. The instrument is based on the self-reported days completing recommended activities during the past 7 days. The blood-glucose testing 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) to one month follow-up (t1)
Change in Diabetes Self-Efficacy
The Perceived Diabetes Self-Management Scale (PDSMS) is a valid measure of diabetes self-efficacy (i.e., how confident they feel about their ability to carry out multiple self management tasks). The uni-dimensional, 8-item scale is scored on a five-point Likert scale. The total PDSMS score can range from 8 to 40, with higher scores indicating more confidence in self-managing one's diabetes.
Measured: Baseline (t0) to one month follow-up (t1)
Change in Medication Adherence
The Adherence to Refills and Medications Scale is a reliable and valid measure of medication adherence. The 12-item scale has item responses range that from 1="none of the time" to 4="all of the time." Responses are summed to produce an overall adherence score ranging from 12-48, with higher scores representing more problems with medication adherence.
Measured: Baseline (t0) to one month follow-up (t1)
Change in Diabetes Distress
The Problem Areas in Diabetes Scale (PAID-5) is a valid measure of diabetes distress. The five-item, uni-dimensional scale has scores that range from 0 to 20, with higher scores suggesting greater diabetes-related emotional distress. The PAID-5 is associated with measures of depression and hemoglobin A1c.
Measured: Baseline (t0) to one month follow-up (t1)
Change in Knowledge of Diabetes Measures
Unique study specific items to assess participants' knowledge of measures of diabetes health status (i.e., hemoglobin A1C, blood pressure, low-density lipoprotein, urine microalbumin, and body mass index). Each item has 1 correct answer and several incorrect answers.
Measured: Baseline (t0) to one month follow-up (t1)
Change in Diabetes Readiness for Change
Four-item assess the participants' stage of change based on the Transtheoretical Model (TTM) of behavior change including one item each for: (1) physical activity, (2) medication management, (3) glucose self-monitoring, and (4) diet. There are five response options per item that categorize the participants' current TTM stage of change across a continuum: (a) Precontemplation [worst], (b) Contemplation, (c) Preparation, (d) Action, and (e) Maintenance [best]. For each item, precontemplation is represented by the response "No, and I do not intend to in the next 6 months"; contemplation is represented by the response "No, but I am thinking about starting in the next 6 months"; Preparation is represented by the response "No, but I am planning to start in the next 30 days"; action is represented by the response "Yes, I have been for less than 6 months"; and maintenance is represented by the response "Yes, I have been for 6 months or more."
Measured: Baseline (t0) to one month follow-up (t1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start22 Dec 2022
- Primary completion9 Jan 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 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
- NCT05448105
- Sponsor's protocol ID
- 220629
- Other IDs
- R01DK131129
- Status last verified
- Mar 2025
- First submitted
- 23 Jun 2022
- Last updated
- 20 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Diabetes Care: A Scalability and Usability Study
- ClinicalTrials.gov ID
- NCT05448105
- Acronym / sponsor ID
- 220629
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Self-efficacy, Patient Web Portals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 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
- 22 Dec 2022 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 7 Jul 2022 (actual)
- Results
- Posted 20 Mar 2025
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 prospective, longitudinal study on the My Diabetes Care (MDC) mobile intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.
Detailed description
Up to 90 adult patients with type 2 diabetes mellitus will be enrolled and given access to My Diabetes Care (MDC). 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 selfcare information. Patients will be invited by mail 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) version 5.0.8. Study participants will complete questionnaires electronically via email using REDCap at two time points: baseline (T0) and one-month follow-up (T1). Participants will complete a baseline questionnaire (T0) including basic demographic questions, items about computer usage and internet access, and validated measures of health literacy and eHealth literacy. Each participant will have access to MDC for 1 month.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| My Diabetes Care (MDC) | Experimental | Other: My Diabetes Care (MDC)Patients have access to a patient web portal embedded with the My Diabetes Care (MDC) intervention. |
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
- Patient at a participating clinic within Vanderbilt Medical Center or Brigham and Women's Hospital
- Able to speak and read in English or Spanish
Key exclusion criteria (3 listed)
- Have a medical condition that affects your memory or ability to think
- Have severe difficulty seeing or hearing
- Have a medical condition that makes it hard for people to understand what you are saying
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 Care (MDC)Also: Patient-facing Diabetes DashboardMy Diabetes Care (MDC) is a multi-faceted patient portal intervention 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 diabetes self-care information. In this study, the MDC user-interface was expanded to display additional diabetes health-data, including urine microalbumin and weight/body mass index (BMI) and a Spanish-language version of MDC was available to Spanish-speaking patients with limited English proficiency. | Other | My Diabetes Care (MDC) |
Primary outcome
Usability
Time frame: One month follow-up (t1)
The System Usability Scale (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 71 or above suggests 'good' usability.
System Usage
Time frame: One month follow-up (t1)
System usage will be assessed by user analytics data capturing participant use to MDC during the study period. MDC use is defined as one or more visits to the MDC site during the study period.
User Experience - Acceptance
Time frame: One month follow-up (t1)
User experience will be assessed by study-specific survey items administered to all study participants at the end of the study period (T1). Survey items will assess agreement on a 5-point Likert scale from Strongly Agree to Strongly Disagree. Participants will be asked whether they would continue to use My Diabetes Care (MDC) going forward were it to remain available and whether they would recommend MDC to other patients with diabetes.
9 secondary outcomes
Change in Diabetes Knowledge
Time frame: Baseline (t0) to one month follow-up (t1)
Change in Diabetes Self-Care - Diet Adherence
Time frame: Baseline (t0) to one month follow-up (t1)
Change in Diabetes Self-Care - Exercise Adherence
Time frame: Baseline (t0) to one month follow-up (t1)
Change in Diabetes Self-Care - Glucose Self-monitoring Adherence
Time frame: Baseline (t0) to one month follow-up (t1)
Change in Diabetes Self-Efficacy
Time frame: Baseline (t0) to one month follow-up (t1)
Change in Medication Adherence
Time frame: Baseline (t0) to one month follow-up (t1)
Change in Diabetes Distress
Time frame: Baseline (t0) to one month follow-up (t1)
Change in Knowledge of Diabetes Measures
Time frame: Baseline (t0) to one month follow-up (t1)
Change in Diabetes Readiness for Change
Time frame: Baseline (t0) to one month follow-up (t1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 (MDC) 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 20 Mar 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?
Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Usability (time frame: One month follow-up (t1)). The study lists 3 primary outcomes in all. 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 20 Mar 2025.