Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, mHealth, Medical Assistant, Automated, Adaptive Feedback, Self-Management Support, Hispanics, HbA1c, Cyberinfrastructure, Federally-Qualified Health Centers, Cost-Effectiveness, T2DM, Pay-for-Performance, Medication Adherence, LDL-C, Systolic Blood Pressure, Text Messaging
Brief summary
This study will compare Dulce Digital (i.e., the investigators' proven-effective combination of one-size-fits-all educational text messages and nurse monitoring of patient-transmitted blood glucose values) and Dulce Digital-Me (DD-Me), an adaptive/dynamic mHealth (mobile health) intervention that is tailored to individuals' needs and behavioral progress, in improving diabetes clinical control, adherence, and patient-provider communication in Hispanics - an at-risk, understudied population that experiences disparities in diabetes prevalence and outcomes. These striking disparities in the growing and aging US Hispanic population have taxed the US healthcare system, while significantly reducing quantity and quality of life for millions of individuals. By offering an innovative, scalable, and sustainable approach that seamlessly integrates several mHealth technologies into existing primary care team processes to improve the health of Hispanics (and eventually, other at-risk, underserved groups), DD-Me has strong potential to significantly impact public health.
Detailed description
Individuals of low socioeconomic (SES) and ethnic minority status, including Hispanics, the largest U.S. ethnic minority group, are disproportionately affected by diabetes. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, thus placing Hispanics at high risk for costly diabetes complications. The investigators' established academic-healthcare-community partnership has unique experience in developing and testing innovative, cost-effective, and sustainable chronic care interventions to reduce disparities and improve health in underserved communities. The investigators recently developed Dulce Digital (i.e., one-size-fits-all educational text messages, with nurse monitoring of patient-transmitted blood glucose values), which improved glycemic control across 6 months, relative to usual care in a recent randomized controlled trial (RCT) of N=126 Hispanic patients with poorly controlled type 2 diabetes (T2DM). The process evaluation for this trial indicated that Dulce Digital was both feasible and acceptable from patient and provider perspectives; however, patients expressed a preference for a more individualized intervention, and providers requested an even greater focus on health behavior change. Thus, the proposed RCT will examine the comparative effectiveness of Dulce Digital versus Dulce Digital-Me (DD-Me) in N=414 Hispanic adults of low SES with poorly controlled T2DM from Neighborhood Healthcare, a San Diego Federally-Qualified Health Center. Guided by patient and provider feedback, DD-Me includes Dulce Digital components plus personalized goal-setting and feedback that is responsive to the individual's needs and preferences. The DD-Me adaptive feedback component will be informed by the Resources and Support for Self-Management Model and Operant Conditioning Theory, and based on the individual's progress on intermediate behavioral targets (i.e., medication adherence assessed by wireless sensor; brief mobile phone-based assessments of diet, physical activity, stress). Feedback will be delivered via algorithm-driven automated messaging in 50% of DD-Me participants and by the care team medical assistant in the remaining half to determine the feasibility and acceptability (given the purported cultural relevance of interpersonal relationships in the Hispanic culture), and the comparative effectiveness and cost of each delivery method. Changes in indicators of diabetes clinical control \[i.e., glycosylated hemoglobin (HbA1c) low density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP)\], patient-provider communication, and patient adherence (i.e., to medication and other diabetes self-management behaviors) will be evaluated across twelve months. Thorough process and cost-effectiveness analyses will evaluate the scalability and sustainability potential of DD-Me. This comparative evaluation of two mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within existing nurse-led chronic care approaches to meet the complex needs of underserved individuals with poorly controlled T2DM.
Interventions
BEHAVIORALDulce Digital
One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.
BEHAVIORALDulce Digital-Me (Automated Delivery)
Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes.
BEHAVIORALDulce Digital-Me (Medical Assistant)
Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes.
Sponsors
University of California, San Diego
San Diego State University
Scripps Whittier Diabetes Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Self-identified Hispanic/Latino 2. 18 years or older 3. Registered patient of a Neighborhood Healthcare Clinic 4. Diagnosed with T2DM (Type 2 Diabetes Mellitus) 5. HbA1c ≥ 8.0% and/or SBP ≥ 160 mmHg, and/or LDL-C ≥ 100 mg/dL in the last 30 days
Exclusion criteria
1. Severe illness precluding regular clinic visits 2. Pregnant or lactating 3. Type 1 or gestational diabetes 4. Lack of minimal literacy 5. Plans to relocate 6. Severe auditory or visual problems 7. Primary language other than Spanish or English 8. Unwilling to carry a mobile phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment | 6 months from baseline | Glycosylated Hemoglobin (HbA1c) six months after enrollment |
| Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment | 12 months from baseline | Glycosylated Hemoglobin (HbA1c) twelve months after enrollment |
| Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment | 6 months from baseline | Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment |
| Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment | 12 months from baseline | Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment |
| Systolic Blood Pressure (SBP); 6 Months From Enrollment | 6 months from baseline | Systolic blood pressure (SBP); six months from enrollment |
| Systolic Blood Pressure (SBP); 12 Months From Enrollment | 12 months from baseline | Systolic blood pressure (SBP); twelve months from enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participated in Strength Exercise; 6 Months From Enrollment | 6 months from baseline | Participated in Strength Exercise as reported by patient; six months from enrollment |
| Participated in Strength Exercise; 12 Months From Enrollment | 12 months from baseline | Participated in Strength Exercise as reported by patient; twelve months from enrollment |
| Participated in Flexibility Exercise; 6 Months From Enrollment | 6 months from baseline | Participated in Flexibility Exercise as reported by patient; six months from enrollment |
| Participated in Flexibility Exercise; 12 Months From Enrollment | 12 months from baseline | Participated in Flexibility Exercise as reported by patient; twelve months from enrollment |
| Healthy Eating Behaviors; 6 Months From Enrollment | 6 months from baseline | Healthy Eating Behaviors as reported by patient; six months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome. |
| Patient-Provider Communication; 6 Months From Enrollment | 6 months from baseline | Patient-Provider Communication as reported by patient; six months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome. |
| Diabetes Distress; 6 Months From Enrollment | 6 months from baseline | Diabetes Distress as reported by patient; six months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome. |
| Diabetes Distress; 12 Months From Enrollment | 12 months from baseline | Diabetes Distress as reported by patient; twelve months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome. |
| Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment | 6 months from baseline | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; six months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome. |
| Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment | 12 months from baseline | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; twelve months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome. |
| Healthy Eating Behaviors; 12 Months From Enrollment | 12 months from baseline | Healthy Eating Behaviors as reported by patient; twelve months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome. |
| Patient-Provider Communication; 12 Months From Enrollment | 12 months from baseline | Patient-Provider Communication as reported by patient; twelve months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome. |
| Patient Blood Glucose Monitoring; 6 Months From Enrollment | 6 months from baseline | Patient Blood Glucose Monitoring as reported by patient; six months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week. A higher value on this scale is a better outcome. |
| Patient Blood Glucose Monitoring; 12 Months From Enrollment | 12 months from baseline | Patient Blood Glucose Monitoring as reported by patient; twelve months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week. A higher value on this scale is a better outcome. |
| Participated in Aerobic Exercise; 6 Months From Enrollment | 6 months from baseline | Participated in Aerobic Exercise as reported by patient, six months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome. |
| Participated in Aerobic Exercise; 12 Months From Enrollment | 12 months from baseline | Participated in Aerobic Exercise as reported by patient, twelve months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome. |
Countries
United States
Participant flow
Recruitment details
Between October 2017 and March 2020, the study enrolled 310 Hispanic adults with low income and poorly managed type 2 diabetes from a San Diego County Federally Qualified Health Center.
Pre-assignment details
The target sample size based on power analysis was N=414. Enrollment started October 31, 2017 was paused on March 13, 2020, and then concluded early due to the COVID-19 pandemic. Because the design accommodated at 30% attrition rate, sample size was adequate for analysis of outcomes.
Participants by arm
| Arm | Count |
|---|---|
| Dulce Digital The first of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives one-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.
Dulce Digital: One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values. | 107 |
| Dulce Digital-Me (Automated Delivery) The second of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes.
Dulce Digital-Me (Automated Delivery): Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes. | 106 |
| Dulce Digital-Me (Medical Assistant) The third of the three arms of the parallel design: The group of participants randomly assigned to this arm of the study receives educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes.
Dulce Digital-Me (Medical Assistant): Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes. | 97 |
| Total | 310 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 34 | 37 | 26 |
| Overall Study | Withdrawal by PI | 1 | 2 | 5 |
| Overall Study | Withdrawal by Subject | 5 | 1 | 0 |
Baseline characteristics
| Characteristic | Dulce Digital-Me (Medical Assistant) | Total | Dulce Digital | Dulce Digital-Me (Automated Delivery) |
|---|---|---|---|---|
| Adherence to Refills and Medications Scale (ARMS) | 18.40 units on a scale STANDARD_DEVIATION 4.4 | 18.18 units on a scale STANDARD_DEVIATION 4.7 | 17.87 units on a scale STANDARD_DEVIATION 3.99 | 18.28 units on a scale STANDARD_DEVIATION 5.6 |
| Age, Continuous | 51.90 years STANDARD_DEVIATION 9.49 | 52.11 years STANDARD_DEVIATION 10.18 | 51.22 years STANDARD_DEVIATION 10.7 | 53.21 years STANDARD_DEVIATION 10.26 |
| BMI | 31.37 units kg/m^2 STANDARD_DEVIATION 6.34 | 32.22 units kg/m^2 STANDARD_DEVIATION 6.54 | 31.84 units kg/m^2 STANDARD_DEVIATION 5.82 | 33.51 units kg/m^2 STANDARD_DEVIATION 7.35 |
| Diabetes Distress | 2.40 units on a scale STANDARD_DEVIATION 0.97 | 2.41 units on a scale STANDARD_DEVIATION 0.99 | 2.39 units on a scale STANDARD_DEVIATION 1.01 | 2.43 units on a scale STANDARD_DEVIATION 0.99 |
| Duration of Diabetes Diagnosis | 10.59 years STANDARD_DEVIATION 8.26 | 10.37 years STANDARD_DEVIATION 8.22 | 10.22 years STANDARD_DEVIATION 8.22 | 10.31 years STANDARD_DEVIATION 8.25 |
| Employment Employed Full Time | 20 Participants | 69 Participants | 30 Participants | 19 Participants |
| Employment Employed Part Time | 32 Participants | 72 Participants | 21 Participants | 19 Participants |
| Employment Not Employed | 45 Participants | 168 Participants | 55 Participants | 68 Participants |
| Employment Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 97 Participants | 310 Participants | 107 Participants | 106 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Glycosylated Hemoglobin (HbA1c) | 9.37 percentage of Glycosylated Hemoglobin STANDARD_DEVIATION 1.56 | 9.31 percentage of Glycosylated Hemoglobin STANDARD_DEVIATION 1.59 | 9.25 percentage of Glycosylated Hemoglobin STANDARD_DEVIATION 1.64 | 9.31 percentage of Glycosylated Hemoglobin STANDARD_DEVIATION 1.58 |
| Has Some Type of Health Insurance | 42 Participants | 152 Participants | 53 Participants | 57 Participants |
| Health Literacy Adequate | 55 Participants | 167 Participants | 56 Participants | 56 Participants |
| Health Literacy Limited | 42 Participants | 143 Participants | 51 Participants | 50 Participants |
| Healthy Eating Behaviors | 49.33 units on a scale STANDARD_DEVIATION 6.88 | 49.76 units on a scale STANDARD_DEVIATION 6.99 | 49.63 units on a scale STANDARD_DEVIATION 6.87 | 50.29 units on a scale STANDARD_DEVIATION 7.23 |
| Less than High School Education/GED | 76 Participants | 230 Participants | 81 Participants | 73 Participants |
| Low-density Lipoprotein-cholesterol (LDL-C); | 100.32 mg/dL STANDARD_DEVIATION 41.03 | 94.72 mg/dL STANDARD_DEVIATION 38 | 93.07 mg/dL STANDARD_DEVIATION 38.75 | 91.17 mg/dL STANDARD_DEVIATION 33.88 |
| Married or Living with Partner | 64 Participants | 203 Participants | 74 Participants | 65 Participants |
| Participated in Aerobic Exercise | 4.73 units on a scale STANDARD_DEVIATION 1.67 | 4.97 units on a scale STANDARD_DEVIATION 1.7 | 5.01 units on a scale STANDARD_DEVIATION 1.64 | 5.14 units on a scale STANDARD_DEVIATION 1.78 |
| Participated in Flexibility Exercise | 46 Participants | 140 Participants | 40 Participants | 54 Participants |
| Participated in Strength Exercise | 17 Participants | 69 Participants | 25 Participants | 27 Participants |
| Patient Blood Glucose Monitoring | 4.38 days per week STANDARD_DEVIATION 2.83 | 4.31 days per week STANDARD_DEVIATION 2.62 | 4.11 days per week STANDARD_DEVIATION 1.26 | 4.46 days per week STANDARD_DEVIATION 2.5 |
| Patient-Provider Communication | 4.12 units on a scale STANDARD_DEVIATION 1.02 | 4.05 units on a scale STANDARD_DEVIATION 1.03 | 4.06 units on a scale STANDARD_DEVIATION 1.03 | 3.97 units on a scale STANDARD_DEVIATION 1.05 |
| Place of Birth Mexico | 89 Participants | 281 Participants | 97 Participants | 95 Participants |
| Place of Birth Other | 2 Participants | 9 Participants | 5 Participants | 2 Participants |
| Place of Birth US 50 States/District of Columbia | 6 Participants | 20 Participants | 5 Participants | 9 Participants |
| Primary Language is Spanish | 90 Participants | 289 Participants | 101 Participants | 98 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 4 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 5 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 68 Participants | 188 Participants | 56 Participants | 64 Participants |
| Race (NIH/OMB) White | 27 Participants | 106 Participants | 42 Participants | 37 Participants |
| Region of Enrollment United States | 97 participants | 310 participants | 107 participants | 106 participants |
| Sex: Female, Male Female | 67 Participants | 216 Participants | 76 Participants | 73 Participants |
| Sex: Female, Male Male | 30 Participants | 94 Participants | 31 Participants | 33 Participants |
| Systolic Blood Pressure (SBP) | 123.08 mm/Hg STANDARD_DEVIATION 20.1 | 122.35 mm/Hg STANDARD_DEVIATION 18.33 | 121.36 mm/Hg STANDARD_DEVIATION 17.11 | 122.69 mm/Hg STANDARD_DEVIATION 17.96 |
| Yearly household income $20,000 to $30,000 | 16 Participants | 49 Participants | 14 Participants | 19 Participants |
| Yearly household income Greater than $30,000 | 10 Participants | 46 Participants | 23 Participants | 13 Participants |
| Yearly household income Less than $20,000 | 63 Participants | 189 Participants | 64 Participants | 62 Participants |
| Yearly household income Unknown or Not Reported | 8 Participants | 26 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 107 | 0 / 106 | 1 / 97 |
| other Total, other adverse events | 0 / 107 | 0 / 106 | 0 / 97 |
| serious Total, serious adverse events | 0 / 107 | 0 / 106 | 0 / 97 |
Outcome results
Primary
Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment
Glycosylated Hemoglobin (HbA1c) twelve months after enrollment
Time frame: 12 months from baseline
Population: Participants that came in for 12-month measures
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment | 8.29 percentage | Standard Deviation 1.62 |
| Dulce Digital-Me (Automated Delivery) | Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment | 8.41 percentage | Standard Deviation 1.7 |
| Dulce Digital-Me (Medical Assistants) | Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment | 8.83 percentage | Standard Deviation 1.83 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment | 8.62 percentage | Standard Deviation 1.77 |
Comparison: Analyses controlled for age, gender, employment, and language.p-value: 0.37Regression, Logistic
Primary
Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment
Glycosylated Hemoglobin (HbA1c) six months after enrollment
Time frame: 6 months from baseline
Population: Participants that came in for 6-month measures
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment | 8.17 percentage | Standard Deviation 1.51 |
| Dulce Digital-Me (Automated Delivery) | Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment | 7.99 percentage | Standard Deviation 1.61 |
| Dulce Digital-Me (Medical Assistants) | Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment | 8.44 percentage | Standard Deviation 1.48 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment | 8.21 percentage | Standard Deviation 1.56 |
Comparison: Analyses controlled for age, gender, employment and language.p-value: 0.95Regression, Logistic
Primary
Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment
Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment
Time frame: 12 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment | 97.85 mg/dL | Standard Deviation 27.74 |
| Dulce Digital-Me (Automated Delivery) | Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment | 94.10 mg/dL | Standard Deviation 35.18 |
| Dulce Digital-Me (Medical Assistants) | Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment | 92.04 mg/dL | Standard Deviation 43.23 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment | 93.08 mg/dL | Standard Deviation 39.18 |
Comparison: Analyses controlled for age, gender, employment, and language.p-value: 0.9Regression, Logistic
Primary
Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment
Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment
Time frame: 6 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment | 90.27 mg/dL | Standard Deviation 33.66 |
| Dulce Digital-Me (Automated Delivery) | Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment | 88.20 mg/dL | Standard Deviation 36.38 |
| Dulce Digital-Me (Medical Assistants) | Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment | 102.93 mg/dL | Standard Deviation 47.96 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment | 95.69 mg/dL | Standard Deviation 43.12 |
Comparison: Analyses controlled for age, gender, employment, and language.p-value: 0.26Regression, Logistic
Primary
Systolic Blood Pressure (SBP); 12 Months From Enrollment
Systolic blood pressure (SBP); twelve months from enrollment
Time frame: 12 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Systolic Blood Pressure (SBP); 12 Months From Enrollment | 125.10 mm/Hg | Standard Deviation 17.38 |
| Dulce Digital-Me (Automated Delivery) | Systolic Blood Pressure (SBP); 12 Months From Enrollment | 122.82 mm/Hg | Standard Deviation 15.29 |
| Dulce Digital-Me (Medical Assistants) | Systolic Blood Pressure (SBP); 12 Months From Enrollment | 124.13 mm/Hg | Standard Deviation 19.54 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Systolic Blood Pressure (SBP); 12 Months From Enrollment | 123.47 mm/Hg | Standard Deviation 17.49 |
Comparison: Analyses controlled for age, gender, employment, and language.p-value: 0.3Regression, Logistic
Primary
Systolic Blood Pressure (SBP); 6 Months From Enrollment
Systolic blood pressure (SBP); six months from enrollment
Time frame: 6 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Systolic Blood Pressure (SBP); 6 Months From Enrollment | 126.70 mm/Hg | Standard Deviation 19.52 |
| Dulce Digital-Me (Automated Delivery) | Systolic Blood Pressure (SBP); 6 Months From Enrollment | 124.84 mm/Hg | Standard Deviation 18.66 |
| Dulce Digital-Me (Medical Assistants) | Systolic Blood Pressure (SBP); 6 Months From Enrollment | 124.78 mm/Hg | Standard Deviation 19.13 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Systolic Blood Pressure (SBP); 6 Months From Enrollment | 124.81 mm/Hg | Standard Deviation 18.83 |
Comparison: Analyses controlled for age, gender, employment, and language.p-value: 0.21Regression, Logistic
Secondary
Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment
Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; twelve months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome.
Time frame: 12 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment | 16.68 score on a scale | Standard Deviation 4.23 |
| Dulce Digital-Me (Automated Delivery) | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment | 16.25 score on a scale | Standard Deviation 4.26 |
| Dulce Digital-Me (Medical Assistants) | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment | 15.85 score on a scale | Standard Deviation 3.88 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment | 16.08 score on a scale | Standard Deviation 4.08 |
Comparison: Analyses controlled for income.p-value: 0.008Regression, Logistic
Secondary
Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment
Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; six months from enrollment The minimum score is 11 and the maximum score is 44. A higher score is a better outcome.
Time frame: 6 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment | 17.23 score on a scale | Standard Deviation 4.38 |
| Dulce Digital-Me (Automated Delivery) | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment | 16.31 score on a scale | Standard Deviation 4.04 |
| Dulce Digital-Me (Medical Assistants) | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment | 16.12 score on a scale | Standard Deviation 3.94 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment | 16.22 score on a scale | Standard Deviation 3.97 |
Comparison: Analyses controlled for income.p-value: 0.002Regression, Logistic
Secondary
Diabetes Distress; 12 Months From Enrollment
Diabetes Distress as reported by patient; twelve months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome.
Time frame: 12 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Diabetes Distress; 12 Months From Enrollment | 1.96 score on a scale | Standard Deviation 0.75 |
| Dulce Digital-Me (Automated Delivery) | Diabetes Distress; 12 Months From Enrollment | 2.23 score on a scale | Standard Deviation 0.96 |
| Dulce Digital-Me (Medical Assistants) | Diabetes Distress; 12 Months From Enrollment | 2.07 score on a scale | Standard Deviation 0.94 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Diabetes Distress; 12 Months From Enrollment | 2.16 score on a scale | Standard Deviation 0.95 |
Comparison: Analyses is controlled for income.p-value: 0.63Regression, Logistic
Secondary
Diabetes Distress; 6 Months From Enrollment
Diabetes Distress as reported by patient; six months from enrollment The minimum score is 1 and the maximum score is 6. A higher score represents a worse outcome.
Time frame: 6 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Diabetes Distress; 6 Months From Enrollment | 2.16 score on a scale | Standard Deviation 0.83 |
| Dulce Digital-Me (Automated Delivery) | Diabetes Distress; 6 Months From Enrollment | 2.12 score on a scale | Standard Deviation 0.93 |
| Dulce Digital-Me (Medical Assistants) | Diabetes Distress; 6 Months From Enrollment | 2.16 score on a scale | Standard Deviation 0.89 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Diabetes Distress; 6 Months From Enrollment | 2.14 score on a scale | Standard Deviation 0.91 |
Comparison: Analyses controlled for income.p-value: 0.63Regression, Logistic
Secondary
Healthy Eating Behaviors; 12 Months From Enrollment
Healthy Eating Behaviors as reported by patient; twelve months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome.
Time frame: 12 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Healthy Eating Behaviors; 12 Months From Enrollment | 51.04 score on a scale | Standard Deviation 6 |
| Dulce Digital-Me (Automated Delivery) | Healthy Eating Behaviors; 12 Months From Enrollment | 50.24 score on a scale | Standard Deviation 5.81 |
| Dulce Digital-Me (Medical Assistants) | Healthy Eating Behaviors; 12 Months From Enrollment | 50.67 score on a scale | Standard Deviation 6.19 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Healthy Eating Behaviors; 12 Months From Enrollment | 50.43 score on a scale | Standard Deviation 5.96 |
Comparison: Analyses controlled for income.p-value: 0.05Regression, Logistic
Secondary
Healthy Eating Behaviors; 6 Months From Enrollment
Healthy Eating Behaviors as reported by patient; six months from enrollment The minimum score is 20 and the maximum score is 76. The higher score represents a better outcome.
Time frame: 6 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Healthy Eating Behaviors; 6 Months From Enrollment | 50.12 score on a scale | Standard Deviation 6.38 |
| Dulce Digital-Me (Automated Delivery) | Healthy Eating Behaviors; 6 Months From Enrollment | 50.48 score on a scale | Standard Deviation 6.96 |
| Dulce Digital-Me (Medical Assistants) | Healthy Eating Behaviors; 6 Months From Enrollment | 49.41 score on a scale | Standard Deviation 6.66 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Healthy Eating Behaviors; 6 Months From Enrollment | 49.98 score on a scale | Standard Deviation 6.82 |
Comparison: Analyses controlled for income.p-value: 0.76Regression, Logistic
Secondary
Participated in Aerobic Exercise; 12 Months From Enrollment
Participated in Aerobic Exercise as reported by patient, twelve months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome.
Time frame: 12 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Participated in Aerobic Exercise; 12 Months From Enrollment | 5.11 score on a scale | Standard Deviation 1.48 |
| Dulce Digital-Me (Automated Delivery) | Participated in Aerobic Exercise; 12 Months From Enrollment | 5.12 score on a scale | Standard Deviation 1.77 |
| Dulce Digital-Me (Medical Assistants) | Participated in Aerobic Exercise; 12 Months From Enrollment | 4.72 score on a scale | Standard Deviation 1.94 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Participated in Aerobic Exercise; 12 Months From Enrollment | 4.94 score on a scale | Standard Deviation 1.85 |
Comparison: Analyses controlled for income.p-value: 0.64Regression, Logistic
Secondary
Participated in Aerobic Exercise; 6 Months From Enrollment
Participated in Aerobic Exercise as reported by patient, six months from enrollment The minimum score is 1 and the maximum score is 7. A higher score is a better outcome.
Time frame: 6 months from baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Participated in Aerobic Exercise; 6 Months From Enrollment | 5.46 score on a scale | Standard Deviation 1.48 |
| Dulce Digital-Me (Automated Delivery) | Participated in Aerobic Exercise; 6 Months From Enrollment | 5.29 score on a scale | Standard Deviation 1.5 |
| Dulce Digital-Me (Medical Assistants) | Participated in Aerobic Exercise; 6 Months From Enrollment | 5.49 score on a scale | Standard Deviation 1.45 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Participated in Aerobic Exercise; 6 Months From Enrollment | 5.41 score on a scale | Standard Deviation 1.47 |
Comparison: Analyses controlled for income.p-value: 0.96Regression, Logistic
Secondary
Participated in Flexibility Exercise; 12 Months From Enrollment
Participated in Flexibility Exercise as reported by patient; twelve months from enrollment
Time frame: 12 months from baseline
Population: Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dulce Digital | Participated in Flexibility Exercise; 12 Months From Enrollment | 29 Participants |
| Dulce Digital-Me (Automated Delivery) | Participated in Flexibility Exercise; 12 Months From Enrollment | 34 Participants |
| Dulce Digital-Me (Medical Assistants) | Participated in Flexibility Exercise; 12 Months From Enrollment | 15 Participants |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Participated in Flexibility Exercise; 12 Months From Enrollment | 49 Participants |
Comparison: Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.p-value: 0.11Regression, Logistic
Secondary
Participated in Flexibility Exercise; 6 Months From Enrollment
Participated in Flexibility Exercise as reported by patient; six months from enrollment
Time frame: 6 months from baseline
Population: Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dulce Digital | Participated in Flexibility Exercise; 6 Months From Enrollment | 44 Participants |
| Dulce Digital-Me (Automated Delivery) | Participated in Flexibility Exercise; 6 Months From Enrollment | 39 Participants |
| Dulce Digital-Me (Medical Assistants) | Participated in Flexibility Exercise; 6 Months From Enrollment | 31 Participants |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Participated in Flexibility Exercise; 6 Months From Enrollment | 70 Participants |
Comparison: Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.p-value: 0.25Regression, Logistic
Secondary
Participated in Strength Exercise; 12 Months From Enrollment
Participated in Strength Exercise as reported by patient; twelve months from enrollment
Time frame: 12 months from baseline
Population: Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dulce Digital | Participated in Strength Exercise; 12 Months From Enrollment | 12 Participants |
| Dulce Digital-Me (Automated Delivery) | Participated in Strength Exercise; 12 Months From Enrollment | 9 Participants |
| Dulce Digital-Me (Medical Assistants) | Participated in Strength Exercise; 12 Months From Enrollment | 8 Participants |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Participated in Strength Exercise; 12 Months From Enrollment | 17 Participants |
Comparison: Binary logistic regression analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.p-value: 0.58Regression, Logistic
Secondary
Participated in Strength Exercise; 6 Months From Enrollment
Participated in Strength Exercise as reported by patient; six months from enrollment
Time frame: 6 months from baseline
Population: Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dulce Digital | Participated in Strength Exercise; 6 Months From Enrollment | 20 Participants |
| Dulce Digital-Me (Automated Delivery) | Participated in Strength Exercise; 6 Months From Enrollment | 11 Participants |
| Dulce Digital-Me (Medical Assistants) | Participated in Strength Exercise; 6 Months From Enrollment | 10 Participants |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Participated in Strength Exercise; 6 Months From Enrollment | 21 Participants |
Comparison: Binary logistic analyses were conducted for this outcome. Unstandardized regression coefficients represent logit coefficients.p-value: 0.87Regression, Logistic
Secondary
Patient Blood Glucose Monitoring; 12 Months From Enrollment
Patient Blood Glucose Monitoring as reported by patient; twelve months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week. A higher value on this scale is a better outcome.
Time frame: 12 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Patient Blood Glucose Monitoring; 12 Months From Enrollment | 5.08 days per week | Standard Deviation 2.19 |
| Dulce Digital-Me (Automated Delivery) | Patient Blood Glucose Monitoring; 12 Months From Enrollment | 4.77 days per week | Standard Deviation 2.65 |
| Dulce Digital-Me (Medical Assistants) | Patient Blood Glucose Monitoring; 12 Months From Enrollment | 5.15 days per week | Standard Deviation 2.41 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Patient Blood Glucose Monitoring; 12 Months From Enrollment | 4.94 days per week | Standard Deviation 2.54 |
Comparison: Analyses controlled for income.p-value: 0.49Regression, Logistic
Secondary
Patient Blood Glucose Monitoring; 6 Months From Enrollment
Patient Blood Glucose Monitoring as reported by patient; six months from enrollment The minimum value on this scale is 1 day per week and the maximum value on this scale is 7 days per week. A higher value on this scale is a better outcome.
Time frame: 6 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Patient Blood Glucose Monitoring; 6 Months From Enrollment | 5.07 days per week | Standard Deviation 2.29 |
| Dulce Digital-Me (Automated Delivery) | Patient Blood Glucose Monitoring; 6 Months From Enrollment | 5.62 days per week | Standard Deviation 1.99 |
| Dulce Digital-Me (Medical Assistants) | Patient Blood Glucose Monitoring; 6 Months From Enrollment | 5.11 days per week | Standard Deviation 2.41 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Patient Blood Glucose Monitoring; 6 Months From Enrollment | 5.37 days per week | Standard Deviation 2.21 |
Comparison: Analyses controlled for income.p-value: 0.61Regression, Logistic
Secondary
Patient-Provider Communication; 12 Months From Enrollment
Patient-Provider Communication as reported by patient; twelve months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome.
Time frame: 12 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Patient-Provider Communication; 12 Months From Enrollment | 4.09 score on a scale | Standard Deviation 1.03 |
| Dulce Digital-Me (Automated Delivery) | Patient-Provider Communication; 12 Months From Enrollment | 3.99 score on a scale | Standard Deviation 1.04 |
| Dulce Digital-Me (Medical Assistants) | Patient-Provider Communication; 12 Months From Enrollment | 4.16 score on a scale | Standard Deviation 0.96 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Patient-Provider Communication; 12 Months From Enrollment | 4.06 score on a scale | Standard Deviation 1 |
Comparison: Analyses controlled for income.p-value: 0.72Regression, Logistic
Secondary
Patient-Provider Communication; 6 Months From Enrollment
Patient-Provider Communication as reported by patient; six months from enrollment The minimum value on the scale is 1 and the maximum value on the scale is 5. A higher score is a better outcome.
Time frame: 6 months from baseline
Population: Participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dulce Digital | Patient-Provider Communication; 6 Months From Enrollment | 4.18 score on a scale | Standard Deviation 1.05 |
| Dulce Digital-Me (Automated Delivery) | Patient-Provider Communication; 6 Months From Enrollment | 4.04 score on a scale | Standard Deviation 1.02 |
| Dulce Digital-Me (Medical Assistants) | Patient-Provider Communication; 6 Months From Enrollment | 4.28 score on a scale | Standard Deviation 0.8 |
| Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) | Patient-Provider Communication; 6 Months From Enrollment | 4.16 score on a scale | Standard Deviation 0.92 |
Comparison: Analyses controlled for income.p-value: 0.9Regression, Logistic