My Diabetes Care: A Scalability and Usability Study

NCT05448105 | Completed Results

• 2 other identifiers: 220629R01DK131129
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus; Self-efficacy; Patient Web Portals

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  One month follow-up (t1)

Secondary Outcomes (9)

• Change in Diabetes Knowledge

  Baseline (t0) to one month follow-up (t1)

• Change in Diabetes Self-Care - Diet Adherence

  Baseline (t0) to one month follow-up (t1)

• Change in Diabetes Self-Care - Exercise Adherence

  Baseline (t0) to one month follow-up (t1)

• Change in Diabetes Self-Care - Glucose Self-monitoring Adherence

  Baseline (t0) to one month follow-up (t1)

• Change in Diabetes Self-Efficacy

  Baseline (t0) to one month follow-up (t1)

Study Arms (1)

My Diabetes Care (MDC)

EXPERIMENTAL

Patients have access to a patient web portal embedded with the My Diabetes Care (MDC) intervention.

Other: My Diabetes Care (MDC)

Interventions

My Diabetes Care (MDC) OTHER

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.

Also known as: Patient-facing Diabetes Dashboard

My Diabetes Care (MDC)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: William Martinez, MD, MS
• Organization: Vanderbilt University Medical Center

william.martinez@vumc.org

615-936-1010

Study Officials

• William Martinez, MD, MS

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: July 7, 2022
• Study Start: December 22, 2022
• Primary Completion: January 9, 2024
• Study Completion: February 22, 2024
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

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.

Locations

US (2)