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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT05448105
Study groupRoleWhat they receive
My Diabetes Care (MDC)ExperimentalPatients 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.

  1. 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)

  2. 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)

  3. 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)
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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.

  1. First posted7 Jul 2022
  2. Study start22 Dec 2022
  3. Primary completion9 Jan 2024
  4. Study completion22 Feb 2024

Resources

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)
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
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.

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.

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My Diabetes Care: A Scalability and Usability Study | AzTrials