Trial Outcomes & Findings for My Diabetes Care: A Scalability and Usability Study (NCT NCT05448105)

NCT ID: NCT05448105

Last Updated: 2025-03-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

67 participants

Primary outcome timeframe

One month follow-up (t1)

Results posted on

2025-03-20

Participant Flow

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

Participant milestones

Participant milestones
Measure
My Diabetes Care (MDC)
Patients have access to a patient 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.
Overall Study
STARTED
63
Overall Study
COMPLETED
63
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

My Diabetes Care: A Scalability and Usability Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
My Diabetes Care (MDC)
n=63 Participants
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.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
42 Participants
n=5 Participants
Age, Categorical
>=65 years
21 Participants
n=5 Participants
Age, Continuous
57.2 years
STANDARD_DEVIATION 12.6 • n=5 Participants
Sex/Gender, Customized
Female
36 Participants
n=5 Participants
Sex/Gender, Customized
Male
26 Participants
n=5 Participants
Sex/Gender, Customized
Other
1 Participants
n=5 Participants
Race/Ethnicity, Customized
White or Caucasian
41 Participants
n=5 Participants
Race/Ethnicity, Customized
Black or African American
18 Participants
n=5 Participants
Race/Ethnicity, Customized
More than one race
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Other
2 Participants
n=5 Participants
Region of Enrollment
United States
63 participants
n=5 Participants
Language
English
57 Participants
n=5 Participants
Language
Spanish
6 Participants
n=5 Participants

PRIMARY outcome

Timeframe: One month follow-up (t1)

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

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.

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=47 Participants
Patients have access to a patient 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.
Usability
75.0 score on a scale
Interval 67.5 to 85.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=63 Participants
Patients have access to a patient 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.
System Usage
Yes
49 Participants
System Usage
No
14 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=49 Participants
Patients have access to a patient 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.
User Experience - Acceptance
Would recommend the intervention to other patients · Strongly agree/ agree
42 Participants
User Experience - Acceptance
Would recommend the intervention to other patients · Neutral/ disagree/ strongly disagree
7 Participants
User Experience - Acceptance
Would continue to use the intervention in future if it remained available · Strongly agree/ agree
37 Participants
User Experience - Acceptance
Would continue to use the intervention in future if it remained available · Neutral/ disagree/ strongly disagree
10 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=49 Participants
Patients have access to a patient 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.
Change in Diabetes Knowledge
baseline questionnaire (t0)
12.0 score on a scale
Interval 10.0 to 13.0
Change in Diabetes Knowledge
one-month follow-up questionnaire (t1)
12.0 score on a scale
Interval 11.0 to 14.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=49 Participants
Patients have access to a patient 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.
Change in Diabetes Self-Care - Diet Adherence
baseline (t0) questionnaire
4.0 score on a scale
Interval 2.8 to 5.0
Change in Diabetes Self-Care - Diet Adherence
one-month follow-up (T1) questionnaire
4.8 score on a scale
Interval 3.5 to 5.5

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=49 Participants
Patients have access to a patient 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.
Change in Diabetes Self-Care - Exercise Adherence
baseline (t0) questionnaire
2.0 score on a scale
Interval 0.5 to 3.5
Change in Diabetes Self-Care - Exercise Adherence
one-month follow-up (T1) questionnaire
2.0 score on a scale
Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=49 Participants
Patients have access to a patient 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.
Change in Diabetes Self-Care - Glucose Self-monitoring Adherence
baseline (t0) questionnaire
4.0 score on a scale
Interval 2.5 to 6.0
Change in Diabetes Self-Care - Glucose Self-monitoring Adherence
one-month follow-up (T1) questionnaire
4.0 score on a scale
Interval 2.0 to 6.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=49 Participants
Patients have access to a patient 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.
Change in Diabetes Self-Efficacy
baseline questionnaire (t0)
25.0 score on a scale
Interval 23.0 to 26.0
Change in Diabetes Self-Efficacy
one-month follow-up questionnaire (t1)
25.0 score on a scale
Interval 23.0 to 27.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=49 Participants
Patients have access to a patient 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.
Change in Medication Adherence
baseline questionnaire (t0)
15.0 score on a scale
Interval 12.0 to 18.0
Change in Medication Adherence
one-month follow-up questionnaire (t1)
15.0 score on a scale
Interval 13.0 to 16.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=49 Participants
Patients have access to a patient 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.
Change in Diabetes Distress
baseline questionnaire (t0)
6.0 score on a scale
Interval 3.0 to 10.0
Change in Diabetes Distress
one-month questionnaire follow-up (t1)
5.0 score on a scale
Interval 2.0 to 8.0

SECONDARY outcome

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

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

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.

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=49 Participants
Patients have access to a patient 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.
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Definition of BMI? · Incorrect
4 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Definition of A1c? · Correct
47 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Definition of A1c? · Incorrect
2 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Goal range for A1c? · Correct
27 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Goal range for A1c? · Incorrect
22 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Definition of systolic blood pressure? · Correct
24 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Definition of systolic blood pressure? · Incorrect
24 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Goal range for systolic blood pressure? · Correct
16 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Goal range for systolic blood pressure? · Incorrect
33 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Definition of LDL cholesterol? · Correct
30 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Definition of LDL cholesterol? · Incorrect
19 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Goal range for LDL cholesterol? · Correct
18 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Goal range for LDL cholesterol? · Incorrect
31 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Definition of urine microalbumin? · Correct
28 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Definition of urine microalbumin? · Incorrect
21 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Goal range for urine microalbumin? · Correct
13 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Goal range for urine microalbumin? · Incorrect
36 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Definition of BMI? · Correct
46 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Definition of BMI? · Incorrect
3 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Goal range for BMI? · Correct
18 Participants
Change in Knowledge of Diabetes Measures
Pre-Intervention (t0): Goal range for BMI? · Incorrect
31 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Definition of A1c? · Correct
46 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Definition of A1c? · Incorrect
3 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Goal range for A1c? · Correct
30 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Goal range for A1c? · Incorrect
19 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Definition of systolic blood pressure? · Correct
31 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Definition of systolic blood pressure? · Incorrect
18 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Goal range for systolic blood pressure? · Correct
19 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Goal range for systolic blood pressure? · Incorrect
30 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Definition of LDL cholesterol? · Correct
37 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Definition of LDL cholesterol? · Incorrect
12 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Goal range for LDL cholesterol? · Correct
23 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Goal range for LDL cholesterol? · Incorrect
26 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Definition of urine microalbumin? · Correct
33 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Definition of urine microalbumin? · Incorrect
16 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Goal range for urine microalbumin? · Correct
16 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Goal range for urine microalbumin? · Incorrect
33 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Definition of BMI? · Correct
45 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Goal range for BMI? · Correct
23 Participants
Change in Knowledge of Diabetes Measures
Post-Intervention (t1): Goal range for BMI? · Incorrect
26 Participants

SECONDARY outcome

Timeframe: 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).

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."

Outcome measures

Outcome measures
Measure
My Diabetes Care (MDC)
n=49 Participants
Patients have access to a patient 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.
Change in Diabetes Readiness for Change
Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends · Contemplation
1 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): follow a healthy diet for people with diabetes · Preparation
11 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week. · Precontemplation
2 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week. · Contemplation
7 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week. · Preparation
19 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week. · Action
5 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): Get least 150 minutes of moderate-intensity physical activity per week. · Maintenance
11 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week. · Precontemplation
1 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week. · Contemplation
6 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week. · Preparation
19 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week. · Action
11 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): Get least 150 minutes of moderate-intensity physical activity per week. · Maintenance
7 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends · Precontemplation
1 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends · Contemplation
7 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends · Preparation
6 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends · Action
10 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): check your blood sugar levels as often as your doctor recommends · Maintenance
19 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends · Precontemplation
3 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends · Preparation
6 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends · Action
12 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): check your blood sugar levels as often as your doctor recommends · Maintenance
22 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): follow a healthy diet for people with diabetes · Precontemplation
2 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): follow a healthy diet for people with diabetes · Contemplation
5 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): follow a healthy diet for people with diabetes · Preparation
12 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): follow a healthy diet for people with diabetes · Action
9 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): follow a healthy diet for people with diabetes · Maintenance
16 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): follow a healthy diet for people with diabetes · Precontemplation
0 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): follow a healthy diet for people with diabetes · Contemplation
3 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): follow a healthy diet for people with diabetes · Action
9 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): follow a healthy diet for people with diabetes · Maintenance
21 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): take your medicines every day as prescribed · Precontemplation
0 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): take your medicines every day as prescribed · Contemplation
0 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): take your medicines every day as prescribed · Preparation
0 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): take your medicines every day as prescribed · Action
3 Participants
Change in Diabetes Readiness for Change
Pre-Intervention (t0): take your medicines every day as prescribed · Maintenance
41 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): take your medicines every day as prescribed · Precontemplation
1 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): take your medicines every day as prescribed · Contemplation
0 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): take your medicines every day as prescribed · Preparation
2 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): take your medicines every day as prescribed · Action
2 Participants
Change in Diabetes Readiness for Change
Post-Intervention (t1): take your medicines every day as prescribed · Maintenance
39 Participants

Adverse Events

My Diabetes Care (MDC)

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

William Martinez, MD, MS

Vanderbilt University Medical Center

Phone: 615-936-1010

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place