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My Diabetes Care: A Scalability and Usability Study

My Diabetes Care: A Scalability and Usability Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05448105
Enrollment
67
Registered
2022-07-07
Start date
2022-12-22
Completion date
2024-02-22
Last updated
2025-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Self-efficacy, Patient Web Portals

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.

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.

Interventions

OTHERMy Diabetes Care (MDC)

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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
UsabilityOne 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 UsageOne 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 - AcceptanceOne 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.

Secondary

MeasureTime frameDescription
Change in Diabetes Self-Care - Glucose Self-monitoring AdherenceBaseline (t0) to one month follow-up (t1)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).
Change in Diabetes Self-EfficacyBaseline (t0) to one month follow-up (t1)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.
Change in Medication AdherenceBaseline (t0) to one month follow-up (t1)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.
Change in Diabetes KnowledgeBaseline (t0) to one month follow-up (t1)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.
Change in Knowledge of Diabetes MeasuresBaseline (t0) to one month follow-up (t1)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.
Change in Diabetes Readiness for ChangeBaseline (t0) to one month follow-up (t1)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.
Change in Diabetes DistressBaseline (t0) to one month follow-up (t1)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.
Change in Diabetes Self-Care - Diet AdherenceBaseline (t0) to one month follow-up (t1)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).
Change in Diabetes Self-Care - Exercise AdherenceBaseline (t0) to one month follow-up (t1)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).

Countries

United States

Participant flow

Pre-assignment details

Of the enrolled participants, 63 completed the baseline questionnaire and were then assigned to the intervention.

Participants by arm

ArmCount
My Diabetes Care (MDC)
Patients have access to a patient web portal embedded with the My Diabetes Care (MDC) intervention. 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.
63
Total63

Baseline characteristics

CharacteristicMy Diabetes Care (MDC)
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
21 Participants
Age, Categorical
Between 18 and 65 years
42 Participants
Age, Continuous57.2 years
STANDARD_DEVIATION 12.6
Language
English
57 Participants
Language
Spanish
6 Participants
Race/Ethnicity, Customized
Black or African American
18 Participants
Race/Ethnicity, Customized
More than one race
2 Participants
Race/Ethnicity, Customized
Other
2 Participants
Race/Ethnicity, Customized
White or Caucasian
41 Participants
Region of Enrollment
United States
63 participants
Sex/Gender, Customized
Female
36 Participants
Sex/Gender, Customized
Male
26 Participants
Sex/Gender, Customized
Other
1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 63
other
Total, other adverse events
0 / 63
serious
Total, serious adverse events
0 / 63

Outcome results

Primary

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.

Time frame: One month follow-up (t1)

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
My Diabetes Care (MDC)System UsageYes49 Participants
My Diabetes Care (MDC)System UsageNo14 Participants
Primary

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.

Time frame: One month follow-up (t1)

Population: 47 participants used to the study intervention during the study period and completed the SUS scale.

ArmMeasureValue (MEDIAN)
My Diabetes Care (MDC)Usability75.0 score on a scale
p-value: 0.02Wilcoxon signed rank test
Primary

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.

Time frame: One month follow-up (t1)

Population: Analysis was limited to participants that used MDC during the study period and participants who responded to the items below on the one month follow-up questionnaire (t1).

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
My Diabetes Care (MDC)User Experience - AcceptanceWould recommend the intervention to other patientsStrongly agree/ agree42 Participants
My Diabetes Care (MDC)User Experience - AcceptanceWould recommend the intervention to other patientsNeutral/ disagree/ strongly disagree7 Participants
My Diabetes Care (MDC)User Experience - AcceptanceWould continue to use the intervention in future if it remained availableStrongly agree/ agree37 Participants
My Diabetes Care (MDC)User Experience - AcceptanceWould continue to use the intervention in future if it remained availableNeutral/ disagree/ strongly disagree10 Participants
Secondary

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.

Time frame: Baseline (t0) to one month follow-up (t1)

Population: Analysis was limited to participants that used MDC during the study period and completed the Problem Areas in Diabetes Scale (PAID-5) on the baseline (t0) and one-month follow-up (t1) questionnaires.

ArmMeasureGroupValue (MEDIAN)
My Diabetes Care (MDC)Change in Diabetes Distressbaseline questionnaire (t0)6.0 score on a scale
My Diabetes Care (MDC)Change in Diabetes Distressone-month questionnaire follow-up (t1)5.0 score on a scale
p-value: 0.22paired Wilcoxon signed-rank sum test
Secondary

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.

Time frame: Baseline (t0) to one month follow-up (t1)

Population: Analysis was limited to participants that used MDC during the study period and completed the Short Diabetes Knowledge Instrument (SDKI) on the baseline (t0) and one-month follow-up (t1) questionnaires.

ArmMeasureGroupValue (MEDIAN)
My Diabetes Care (MDC)Change in Diabetes Knowledgebaseline questionnaire (t0)12.0 score on a scale
My Diabetes Care (MDC)Change in Diabetes Knowledgeone-month follow-up questionnaire (t1)12.0 score on a scale
p-value: 0.04paired Wilcoxon signed-rank sum test
Secondary

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.

Time frame: Baseline (t0) to one month follow-up (t1)

Population: Analysis is limited to participants that (1) used MDC during the study period AND (2) completed the survey items at the corresponding timepoints pre-intervention (t0) and post-intervention (T1).

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week.Precontemplation2 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week.Contemplation7 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week.Preparation19 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week.Action5 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week.Maintenance11 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week.Precontemplation1 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week.Contemplation6 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week.Preparation19 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week.Action11 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week.Maintenance7 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): check your blood sugar levels as often as your doctor recommendsPrecontemplation1 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): check your blood sugar levels as often as your doctor recommendsContemplation7 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): check your blood sugar levels as often as your doctor recommendsPreparation6 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): check your blood sugar levels as often as your doctor recommendsAction10 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): check your blood sugar levels as often as your doctor recommendsMaintenance19 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): check your blood sugar levels as often as your doctor recommendsPrecontemplation3 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): check your blood sugar levels as often as your doctor recommendsContemplation1 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): check your blood sugar levels as often as your doctor recommendsPreparation6 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): check your blood sugar levels as often as your doctor recommendsAction12 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): check your blood sugar levels as often as your doctor recommendsMaintenance22 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): follow a healthy diet for people with diabetesPrecontemplation2 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): follow a healthy diet for people with diabetesContemplation5 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): follow a healthy diet for people with diabetesPreparation12 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): follow a healthy diet for people with diabetesAction9 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): follow a healthy diet for people with diabetesMaintenance16 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): follow a healthy diet for people with diabetesPrecontemplation0 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): follow a healthy diet for people with diabetesContemplation3 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): follow a healthy diet for people with diabetesPreparation11 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): follow a healthy diet for people with diabetesAction9 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): follow a healthy diet for people with diabetesMaintenance21 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): take your medicines every day as prescribedPrecontemplation0 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): take your medicines every day as prescribedContemplation0 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): take your medicines every day as prescribedPreparation0 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): take your medicines every day as prescribedAction3 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePre-Intervention (t0): take your medicines every day as prescribedMaintenance41 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): take your medicines every day as prescribedPrecontemplation1 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): take your medicines every day as prescribedContemplation0 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): take your medicines every day as prescribedPreparation2 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): take your medicines every day as prescribedAction2 Participants
My Diabetes Care (MDC)Change in Diabetes Readiness for ChangePost-Intervention (t1): take your medicines every day as prescribedMaintenance39 Participants
Secondary

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).

Time frame: Baseline (t0) to one month follow-up (t1)

Population: Analysis was limited to participants that used MDC during the study period and completed the Summary of Diabetes Self-Care Activity (SDSCA) scale diet subdomain on the baseline (t0) and one-month follow-up (t1) questionnaires.

ArmMeasureGroupValue (MEDIAN)
My Diabetes Care (MDC)Change in Diabetes Self-Care - Diet Adherencebaseline (t0) questionnaire4.0 score on a scale
My Diabetes Care (MDC)Change in Diabetes Self-Care - Diet Adherenceone-month follow-up (T1) questionnaire4.8 score on a scale
p-value: <0.01paired Wilcoxon signed-rank sum test
Secondary

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).

Time frame: Baseline (t0) to one month follow-up (t1)

Population: Analysis was limited to participants that used MDC during the study period and completed the Summary of Diabetes Self-Care Activity (SDSCA) scale exercise subdomain on the baseline (t0) and one-month follow-up (t1) questionnaires.

ArmMeasureGroupValue (MEDIAN)
My Diabetes Care (MDC)Change in Diabetes Self-Care - Exercise Adherencebaseline (t0) questionnaire2.0 score on a scale
My Diabetes Care (MDC)Change in Diabetes Self-Care - Exercise Adherenceone-month follow-up (T1) questionnaire2.0 score on a scale
p-value: 0.16paired Wilcoxon signed-rank sum test
Secondary

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).

Time frame: Baseline (t0) to one month follow-up (t1)

Population: Analysis was limited to participants that used MDC during the study period and completed the Summary of Diabetes Self-Care Activity (SDSCA) scale exercise subdomain on the baseline (t0) and one-month follow-up (t1) questionnaires.

ArmMeasureGroupValue (MEDIAN)
My Diabetes Care (MDC)Change in Diabetes Self-Care - Glucose Self-monitoring Adherencebaseline (t0) questionnaire4.0 score on a scale
My Diabetes Care (MDC)Change in Diabetes Self-Care - Glucose Self-monitoring Adherenceone-month follow-up (T1) questionnaire4.0 score on a scale
p-value: 0.69paired Wilcoxon signed-rank sum test
Secondary

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.

Time frame: Baseline (t0) to one month follow-up (t1)

Population: Analysis was limited to participants that used MDC during the study period and completed the Perceived Diabetes Self-Management Scale (PDSMS) on the baseline (t0) and one-month follow-up (t1) questionnaires.

ArmMeasureGroupValue (MEDIAN)
My Diabetes Care (MDC)Change in Diabetes Self-Efficacybaseline questionnaire (t0)25.0 score on a scale
My Diabetes Care (MDC)Change in Diabetes Self-Efficacyone-month follow-up questionnaire (t1)25.0 score on a scale
p-value: 0.9paired Wilcoxon signed-rank sum test
Secondary

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.

Time frame: Baseline (t0) to one month follow-up (t1)

Population: Analysis was limited to participants that used MDC during the study period.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Definition of BMI?Incorrect4 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Definition of A1c?Correct47 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Definition of A1c?Incorrect2 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Goal range for A1c?Correct27 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Goal range for A1c?Incorrect22 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Definition of systolic blood pressure?Correct24 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Definition of systolic blood pressure?Incorrect24 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Goal range for systolic blood pressure?Correct16 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Goal range for systolic blood pressure?Incorrect33 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Definition of LDL cholesterol?Correct30 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Definition of LDL cholesterol?Incorrect19 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Goal range for LDL cholesterol?Correct18 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Goal range for LDL cholesterol?Incorrect31 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Definition of urine microalbumin?Correct28 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Definition of urine microalbumin?Incorrect21 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Goal range for urine microalbumin?Correct13 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Goal range for urine microalbumin?Incorrect36 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Definition of BMI?Correct46 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Definition of BMI?Incorrect3 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Goal range for BMI?Correct18 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPre-Intervention (t0): Goal range for BMI?Incorrect31 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Definition of A1c?Correct46 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Definition of A1c?Incorrect3 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Goal range for A1c?Correct30 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Goal range for A1c?Incorrect19 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Definition of systolic blood pressure?Correct31 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Definition of systolic blood pressure?Incorrect18 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Goal range for systolic blood pressure?Correct19 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Goal range for systolic blood pressure?Incorrect30 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Definition of LDL cholesterol?Correct37 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Definition of LDL cholesterol?Incorrect12 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Goal range for LDL cholesterol?Correct23 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Goal range for LDL cholesterol?Incorrect26 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Definition of urine microalbumin?Correct33 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Definition of urine microalbumin?Incorrect16 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Goal range for urine microalbumin?Correct16 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Goal range for urine microalbumin?Incorrect33 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Definition of BMI?Correct45 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Goal range for BMI?Correct23 Participants
My Diabetes Care (MDC)Change in Knowledge of Diabetes MeasuresPost-Intervention (t1): Goal range for BMI?Incorrect26 Participants
Comparison: Analysis for pre-post change in knowledge of definition of A1Cp-value: 1McNemar
Comparison: Analysis for pre-post change in knowledge of goal range for hemoglobin A1c.p-value: 0.55McNemar
Comparison: Analysis for pre-post change in knowledge of definition of systolic blood pressurep-value: 0.11McNemar
Comparison: Analysis of pre-post change in knowledge of goal range for systolic blood pressurep-value: 0.63McNemar
Comparison: Analysis of pre-post change in knowledge of definition of LDL cholesterolp-value: 0.12McNemar
Comparison: Analysis for pre-post change in knowledge of goal range for LDL cholesterolp-value: 0.33McNemar
Comparison: Analysis of pre-post change in knowledge of definition of urine microalbuminp-value: 0.23McNemar
Comparison: Analysis for pre-post change in knowledge of goal range for urine microalbuminp-value: 0.58McNemar
Comparison: Analysis of pre-post change in knowledge of definition of body mass index (BMI)p-value: 1McNemar
Comparison: Analysis for pre-post change in knowledge of goal range for body mass index (BMI)p-value: 0.27McNemar
Secondary

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.

Time frame: Baseline (t0) to one month follow-up (t1)

Population: Analysis was limited to participants that used MDC during the study period and completed the Adherence to Refills and Medications Scale on the baseline (t0) and one-month follow-up (t1) questionnaires.

ArmMeasureGroupValue (MEDIAN)
My Diabetes Care (MDC)Change in Medication Adherencebaseline questionnaire (t0)15.0 score on a scale
My Diabetes Care (MDC)Change in Medication Adherenceone-month follow-up questionnaire (t1)15.0 score on a scale
p-value: 0.11paired Wilcoxon signed-rank sum test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026