Trial Outcomes & Findings for Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes (NCT NCT03130699)
NCT ID: NCT03130699
Last Updated: 2025-06-25
Results Overview
Glycosylated Hemoglobin (HbA1c) six months after enrollment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
310 participants
Primary outcome timeframe
6 months from baseline
Results posted on
2025-06-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
107
|
106
|
97
|
|
Overall Study
COMPLETED
|
67
|
66
|
65
|
|
Overall Study
NOT COMPLETED
|
40
|
40
|
32
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
34
|
37
|
26
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
0
|
|
Overall Study
Withdrawal by PI
|
1
|
2
|
5
|
|
Overall Study
Death
|
0
|
0
|
1
|
Baseline Characteristics
Sample sizes differ due to missing values.
Baseline characteristics by cohort
| Measure |
Dulce Digital
n=107 Participants
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.
|
Dulce Digital-Me (Automated Delivery)
n=106 Participants
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.
|
Dulce Digital-Me (Medical Assistant)
n=97 Participants
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.
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.22 years
STANDARD_DEVIATION 10.7 • n=107 Participants
|
53.21 years
STANDARD_DEVIATION 10.26 • n=106 Participants
|
51.90 years
STANDARD_DEVIATION 9.49 • n=97 Participants
|
52.11 years
STANDARD_DEVIATION 10.18 • n=310 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=107 Participants
|
73 Participants
n=106 Participants
|
67 Participants
n=97 Participants
|
216 Participants
n=310 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=107 Participants
|
33 Participants
n=106 Participants
|
30 Participants
n=97 Participants
|
94 Participants
n=310 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
107 Participants
n=107 Participants
|
106 Participants
n=106 Participants
|
97 Participants
n=97 Participants
|
310 Participants
n=310 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=107 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=310 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=107 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=97 Participants
|
0 Participants
n=310 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=107 Participants
|
1 Participants
n=106 Participants
|
0 Participants
n=97 Participants
|
4 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=107 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=97 Participants
|
1 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=107 Participants
|
1 Participants
n=106 Participants
|
1 Participants
n=97 Participants
|
3 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=107 Participants
|
1 Participants
n=106 Participants
|
0 Participants
n=97 Participants
|
3 Participants
n=310 Participants
|
|
Race (NIH/OMB)
White
|
42 Participants
n=107 Participants
|
37 Participants
n=106 Participants
|
27 Participants
n=97 Participants
|
106 Participants
n=310 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=107 Participants
|
2 Participants
n=106 Participants
|
1 Participants
n=97 Participants
|
5 Participants
n=310 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
56 Participants
n=107 Participants
|
64 Participants
n=106 Participants
|
68 Participants
n=97 Participants
|
188 Participants
n=310 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=107 Participants
|
106 participants
n=106 Participants
|
97 participants
n=97 Participants
|
310 participants
n=310 Participants
|
|
Less than High School Education/GED
|
81 Participants
n=107 Participants
|
73 Participants
n=106 Participants
|
76 Participants
n=97 Participants
|
230 Participants
n=310 Participants
|
|
Yearly household income
Less than $20,000
|
64 Participants
n=107 Participants
|
62 Participants
n=106 Participants
|
63 Participants
n=97 Participants
|
189 Participants
n=310 Participants
|
|
Yearly household income
$20,000 to $30,000
|
14 Participants
n=107 Participants
|
19 Participants
n=106 Participants
|
16 Participants
n=97 Participants
|
49 Participants
n=310 Participants
|
|
Yearly household income
Greater than $30,000
|
23 Participants
n=107 Participants
|
13 Participants
n=106 Participants
|
10 Participants
n=97 Participants
|
46 Participants
n=310 Participants
|
|
Yearly household income
Unknown or Not Reported
|
6 Participants
n=107 Participants
|
12 Participants
n=106 Participants
|
8 Participants
n=97 Participants
|
26 Participants
n=310 Participants
|
|
Employment
Not Employed
|
55 Participants
n=107 Participants
|
68 Participants
n=106 Participants
|
45 Participants
n=97 Participants
|
168 Participants
n=310 Participants
|
|
Employment
Employed Part Time
|
21 Participants
n=107 Participants
|
19 Participants
n=106 Participants
|
32 Participants
n=97 Participants
|
72 Participants
n=310 Participants
|
|
Employment
Employed Full Time
|
30 Participants
n=107 Participants
|
19 Participants
n=106 Participants
|
20 Participants
n=97 Participants
|
69 Participants
n=310 Participants
|
|
Employment
Unknown or Not Reported
|
1 Participants
n=107 Participants
|
0 Participants
n=106 Participants
|
0 Participants
n=97 Participants
|
1 Participants
n=310 Participants
|
|
Married or Living with Partner
|
74 Participants
n=107 Participants
|
65 Participants
n=106 Participants
|
64 Participants
n=97 Participants
|
203 Participants
n=310 Participants
|
|
Place of Birth
US 50 States/District of Columbia
|
5 Participants
n=107 Participants
|
9 Participants
n=106 Participants
|
6 Participants
n=97 Participants
|
20 Participants
n=310 Participants
|
|
Place of Birth
Mexico
|
97 Participants
n=107 Participants
|
95 Participants
n=106 Participants
|
89 Participants
n=97 Participants
|
281 Participants
n=310 Participants
|
|
Place of Birth
Other
|
5 Participants
n=107 Participants
|
2 Participants
n=106 Participants
|
2 Participants
n=97 Participants
|
9 Participants
n=310 Participants
|
|
Primary Language is Spanish
|
101 Participants
n=107 Participants
|
98 Participants
n=106 Participants
|
90 Participants
n=97 Participants
|
289 Participants
n=310 Participants
|
|
Has Some Type of Health Insurance
|
53 Participants
n=107 Participants
|
57 Participants
n=106 Participants
|
42 Participants
n=97 Participants
|
152 Participants
n=310 Participants
|
|
Health Literacy
Adequate
|
56 Participants
n=107 Participants
|
56 Participants
n=106 Participants
|
55 Participants
n=97 Participants
|
167 Participants
n=310 Participants
|
|
Health Literacy
Limited
|
51 Participants
n=107 Participants
|
50 Participants
n=106 Participants
|
42 Participants
n=97 Participants
|
143 Participants
n=310 Participants
|
|
Duration of Diabetes Diagnosis
|
10.22 years
STANDARD_DEVIATION 8.22 • n=107 Participants
|
10.31 years
STANDARD_DEVIATION 8.25 • n=106 Participants
|
10.59 years
STANDARD_DEVIATION 8.26 • n=97 Participants
|
10.37 years
STANDARD_DEVIATION 8.22 • n=310 Participants
|
|
BMI
|
31.84 units kg/m^2
STANDARD_DEVIATION 5.82 • n=107 Participants
|
33.51 units kg/m^2
STANDARD_DEVIATION 7.35 • n=106 Participants
|
31.37 units kg/m^2
STANDARD_DEVIATION 6.34 • n=97 Participants
|
32.22 units kg/m^2
STANDARD_DEVIATION 6.54 • n=310 Participants
|
|
Glycosylated Hemoglobin (HbA1c)
|
9.25 percentage of Glycosylated Hemoglobin
STANDARD_DEVIATION 1.64 • n=107 Participants
|
9.31 percentage of Glycosylated Hemoglobin
STANDARD_DEVIATION 1.58 • n=106 Participants
|
9.37 percentage of Glycosylated Hemoglobin
STANDARD_DEVIATION 1.56 • n=97 Participants
|
9.31 percentage of Glycosylated Hemoglobin
STANDARD_DEVIATION 1.59 • n=310 Participants
|
|
Low-density Lipoprotein-cholesterol (LDL-C);
|
93.07 mg/dL
STANDARD_DEVIATION 38.75 • n=102 Participants • Sample sizes differ due to missing values.
|
91.17 mg/dL
STANDARD_DEVIATION 33.88 • n=102 Participants • Sample sizes differ due to missing values.
|
100.32 mg/dL
STANDARD_DEVIATION 41.03 • n=95 Participants • Sample sizes differ due to missing values.
|
94.72 mg/dL
STANDARD_DEVIATION 38.00 • n=299 Participants • Sample sizes differ due to missing values.
|
|
Systolic Blood Pressure (SBP)
|
121.36 mm/Hg
STANDARD_DEVIATION 17.11 • n=106 Participants • Sample sizes differ due to missing values.
|
122.69 mm/Hg
STANDARD_DEVIATION 17.96 • n=104 Participants • Sample sizes differ due to missing values.
|
123.08 mm/Hg
STANDARD_DEVIATION 20.10 • n=95 Participants • Sample sizes differ due to missing values.
|
122.35 mm/Hg
STANDARD_DEVIATION 18.33 • n=305 Participants • Sample sizes differ due to missing values.
|
|
Patient-Provider Communication
|
4.06 units on a scale
STANDARD_DEVIATION 1.03 • n=104 Participants • Sample sizes differ due to missing values.
|
3.97 units on a scale
STANDARD_DEVIATION 1.05 • n=102 Participants • Sample sizes differ due to missing values.
|
4.12 units on a scale
STANDARD_DEVIATION 1.02 • n=95 Participants • Sample sizes differ due to missing values.
|
4.05 units on a scale
STANDARD_DEVIATION 1.03 • n=301 Participants • Sample sizes differ due to missing values.
|
|
Patient Blood Glucose Monitoring
|
4.11 days per week
STANDARD_DEVIATION 1.26 • n=102 Participants • Sample sizes differ due to missing values.
|
4.46 days per week
STANDARD_DEVIATION 2.50 • n=95 Participants • Sample sizes differ due to missing values.
|
4.38 days per week
STANDARD_DEVIATION 2.83 • n=84 Participants • Sample sizes differ due to missing values.
|
4.31 days per week
STANDARD_DEVIATION 2.62 • n=281 Participants • Sample sizes differ due to missing values.
|
|
Participated in Aerobic Exercise
|
5.01 units on a scale
STANDARD_DEVIATION 1.64 • n=104 Participants • Sample sizes differ due to missing values.
|
5.14 units on a scale
STANDARD_DEVIATION 1.78 • n=98 Participants • Sample sizes differ due to missing values.
|
4.73 units on a scale
STANDARD_DEVIATION 1.67 • n=88 Participants • Sample sizes differ due to missing values.
|
4.97 units on a scale
STANDARD_DEVIATION 1.70 • n=290 Participants • Sample sizes differ due to missing values.
|
|
Participated in Strength Exercise
|
25 Participants
n=107 Participants
|
27 Participants
n=106 Participants
|
17 Participants
n=97 Participants
|
69 Participants
n=310 Participants
|
|
Participated in Flexibility Exercise
|
40 Participants
n=107 Participants
|
54 Participants
n=106 Participants
|
46 Participants
n=97 Participants
|
140 Participants
n=310 Participants
|
|
Healthy Eating Behaviors
|
49.63 units on a scale
STANDARD_DEVIATION 6.87 • n=107 Participants
|
50.29 units on a scale
STANDARD_DEVIATION 7.23 • n=106 Participants
|
49.33 units on a scale
STANDARD_DEVIATION 6.88 • n=97 Participants
|
49.76 units on a scale
STANDARD_DEVIATION 6.99 • n=310 Participants
|
|
Diabetes Distress
|
2.39 units on a scale
STANDARD_DEVIATION 1.01 • n=105 Participants • Sample sizes differ due to missing values.
|
2.43 units on a scale
STANDARD_DEVIATION 0.99 • n=101 Participants • Sample sizes differ due to missing values.
|
2.40 units on a scale
STANDARD_DEVIATION 0.97 • n=95 Participants • Sample sizes differ due to missing values.
|
2.41 units on a scale
STANDARD_DEVIATION 0.99 • n=301 Participants • Sample sizes differ due to missing values.
|
|
Adherence to Refills and Medications Scale (ARMS)
|
17.87 units on a scale
STANDARD_DEVIATION 3.99 • n=104 Participants • Sample sizes differ due to missing values.
|
18.28 units on a scale
STANDARD_DEVIATION 5.60 • n=99 Participants • Sample sizes differ due to missing values.
|
18.40 units on a scale
STANDARD_DEVIATION 4.40 • n=94 Participants • Sample sizes differ due to missing values.
|
18.18 units on a scale
STANDARD_DEVIATION 4.70 • n=297 Participants • Sample sizes differ due to missing values.
|
PRIMARY outcome
Timeframe: 6 months from baselinePopulation: Participants that came in for 6-month measures
Glycosylated Hemoglobin (HbA1c) six months after enrollment
Outcome measures
| Measure |
Dulce Digital
n=77 Participants
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-Me (Automated Delivery)
n=76 Participants
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 (Medical Assistants)
n=73 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=149 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment
|
8.17 percentage
Standard Deviation 1.51
|
7.99 percentage
Standard Deviation 1.61
|
8.44 percentage
Standard Deviation 1.48
|
8.21 percentage
Standard Deviation 1.56
|
PRIMARY outcome
Timeframe: 12 months from baselinePopulation: Participants that came in for 12-month measures
Glycosylated Hemoglobin (HbA1c) twelve months after enrollment
Outcome measures
| Measure |
Dulce Digital
n=67 Participants
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-Me (Automated Delivery)
n=66 Participants
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 (Medical Assistants)
n=65 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=131 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment
|
8.29 percentage
Standard Deviation 1.62
|
8.41 percentage
Standard Deviation 1.70
|
8.83 percentage
Standard Deviation 1.83
|
8.62 percentage
Standard Deviation 1.77
|
PRIMARY outcome
Timeframe: 6 months from baselinePopulation: Participants
Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment
Outcome measures
| Measure |
Dulce Digital
n=60 Participants
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-Me (Automated Delivery)
n=56 Participants
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 (Medical Assistants)
n=58 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=174 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment
|
90.27 mg/dL
Standard Deviation 33.66
|
88.20 mg/dL
Standard Deviation 36.38
|
102.93 mg/dL
Standard Deviation 47.96
|
95.69 mg/dL
Standard Deviation 43.12
|
PRIMARY outcome
Timeframe: 12 months from baselinePopulation: Participants
Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment
Outcome measures
| Measure |
Dulce Digital
n=41 Participants
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-Me (Automated Delivery)
n=49 Participants
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 (Medical Assistants)
n=48 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=138 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment
|
97.85 mg/dL
Standard Deviation 27.74
|
94.10 mg/dL
Standard Deviation 35.18
|
92.04 mg/dL
Standard Deviation 43.23
|
93.08 mg/dL
Standard Deviation 39.18
|
PRIMARY outcome
Timeframe: 6 months from baselinePopulation: Participants
Systolic blood pressure (SBP); six months from enrollment
Outcome measures
| Measure |
Dulce Digital
n=79 Participants
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-Me (Automated Delivery)
n=73 Participants
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 (Medical Assistants)
n=72 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=154 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Systolic Blood Pressure (SBP); 6 Months From Enrollment
|
126.70 mm/Hg
Standard Deviation 19.52
|
124.84 mm/Hg
Standard Deviation 18.66
|
124.78 mm/Hg
Standard Deviation 19.13
|
124.81 mm/Hg
Standard Deviation 18.83
|
PRIMARY outcome
Timeframe: 12 months from baselinePopulation: Participants
Systolic blood pressure (SBP); twelve months from enrollment
Outcome measures
| Measure |
Dulce Digital
n=64 Participants
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-Me (Automated Delivery)
n=67 Participants
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 (Medical Assistants)
n=67 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=134 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Systolic Blood Pressure (SBP); 12 Months From Enrollment
|
125.10 mm/Hg
Standard Deviation 17.38
|
122.82 mm/Hg
Standard Deviation 15.29
|
124.13 mm/Hg
Standard Deviation 19.54
|
123.47 mm/Hg
Standard Deviation 17.49
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=70 Participants
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-Me (Automated Delivery)
n=64 Participants
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 (Medical Assistants)
n=62 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=126 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Patient-Provider Communication; 6 Months From Enrollment
|
4.18 score on a scale
Standard Deviation 1.05
|
4.04 score on a scale
Standard Deviation 1.02
|
4.28 score on a scale
Standard Deviation 0.80
|
4.16 score on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=54 Participants
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-Me (Automated Delivery)
n=60 Participants
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 (Medical Assistants)
n=48 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=108 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Patient-Provider Communication; 12 Months From Enrollment
|
4.09 score on a scale
Standard Deviation 1.03
|
3.99 score on a scale
Standard Deviation 1.04
|
4.16 score on a scale
Standard Deviation 0.96
|
4.06 score on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=69 Participants
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-Me (Automated Delivery)
n=63 Participants
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 (Medical Assistants)
n=61 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=124 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Patient Blood Glucose Monitoring; 6 Months From Enrollment
|
5.07 days per week
Standard Deviation 2.29
|
5.62 days per week
Standard Deviation 1.99
|
5.11 days per week
Standard Deviation 2.41
|
5.37 days per week
Standard Deviation 2.21
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=52 Participants
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-Me (Automated Delivery)
n=60 Participants
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 (Medical Assistants)
n=48 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=108 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Patient Blood Glucose Monitoring; 12 Months From Enrollment
|
5.08 days per week
Standard Deviation 2.19
|
4.77 days per week
Standard Deviation 2.65
|
5.15 days per week
Standard Deviation 2.41
|
4.94 days per week
Standard Deviation 2.54
|
SECONDARY outcome
Timeframe: 6 months from baselineParticipated 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.
Outcome measures
| Measure |
Dulce Digital
n=68 Participants
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-Me (Automated Delivery)
n=63 Participants
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 (Medical Assistants)
n=61 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=124 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Participated in Aerobic Exercise; 6 Months From Enrollment
|
5.46 score on a scale
Standard Deviation 1.48
|
5.29 score on a scale
Standard Deviation 1.50
|
5.49 score on a scale
Standard Deviation 1.45
|
5.41 score on a scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=54 Participants
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-Me (Automated Delivery)
n=57 Participants
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 (Medical Assistants)
n=47 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=104 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Participated in Aerobic Exercise; 12 Months From Enrollment
|
5.11 score on a scale
Standard Deviation 1.48
|
5.12 score on a scale
Standard Deviation 1.77
|
4.72 score on a scale
Standard Deviation 1.94
|
4.94 score on a scale
Standard Deviation 1.85
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: Participants
Participated in Strength Exercise as reported by patient; six months from enrollment
Outcome measures
| Measure |
Dulce Digital
n=89 Participants
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-Me (Automated Delivery)
n=85 Participants
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 (Medical Assistants)
n=74 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=159 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Participated in Strength Exercise; 6 Months From Enrollment
|
20 Participants
|
11 Participants
|
10 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: Participants
Participated in Strength Exercise as reported by patient; twelve months from enrollment
Outcome measures
| Measure |
Dulce Digital
n=56 Participants
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-Me (Automated Delivery)
n=63 Participants
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 (Medical Assistants)
n=51 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=114 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Participated in Strength Exercise; 12 Months From Enrollment
|
12 Participants
|
9 Participants
|
8 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: Participants
Participated in Flexibility Exercise as reported by patient; six months from enrollment
Outcome measures
| Measure |
Dulce Digital
n=89 Participants
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-Me (Automated Delivery)
n=85 Participants
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 (Medical Assistants)
n=74 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=159 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Participated in Flexibility Exercise; 6 Months From Enrollment
|
44 Participants
|
39 Participants
|
31 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: Participants
Participated in Flexibility Exercise as reported by patient; twelve months from enrollment
Outcome measures
| Measure |
Dulce Digital
n=56 Participants
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-Me (Automated Delivery)
n=63 Participants
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 (Medical Assistants)
n=51 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=114 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Participated in Flexibility Exercise; 12 Months From Enrollment
|
29 Participants
|
34 Participants
|
15 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=89 Participants
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-Me (Automated Delivery)
n=85 Participants
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 (Medical Assistants)
n=74 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=159 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Healthy Eating Behaviors; 6 Months From Enrollment
|
50.12 score on a scale
Standard Deviation 6.38
|
50.48 score on a scale
Standard Deviation 6.96
|
49.41 score on a scale
Standard Deviation 6.66
|
49.98 score on a scale
Standard Deviation 6.82
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=56 Participants
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-Me (Automated Delivery)
n=63 Participants
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 (Medical Assistants)
n=51 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=114 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Healthy Eating Behaviors; 12 Months From Enrollment
|
51.04 score on a scale
Standard Deviation 6.0
|
50.24 score on a scale
Standard Deviation 5.81
|
50.67 score on a scale
Standard Deviation 6.19
|
50.43 score on a scale
Standard Deviation 5.96
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=70 Participants
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-Me (Automated Delivery)
n=65 Participants
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 (Medical Assistants)
n=62 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=127 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Diabetes Distress; 6 Months From Enrollment
|
2.16 score on a scale
Standard Deviation 0.83
|
2.12 score on a scale
Standard Deviation 0.93
|
2.16 score on a scale
Standard Deviation 0.89
|
2.14 score on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=53 Participants
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-Me (Automated Delivery)
n=60 Participants
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 (Medical Assistants)
n=48 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=108 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Diabetes Distress; 12 Months From Enrollment
|
1.96 score on a scale
Standard Deviation 0.75
|
2.23 score on a scale
Standard Deviation 0.96
|
2.07 score on a scale
Standard Deviation 0.94
|
2.16 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: 6 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=70 Participants
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-Me (Automated Delivery)
n=64 Participants
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 (Medical Assistants)
n=62 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=126 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment
|
17.23 score on a scale
Standard Deviation 4.38
|
16.31 score on a scale
Standard Deviation 4.04
|
16.12 score on a scale
Standard Deviation 3.94
|
16.22 score on a scale
Standard Deviation 3.97
|
SECONDARY outcome
Timeframe: 12 months from baselinePopulation: Participants
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.
Outcome measures
| Measure |
Dulce Digital
n=53 Participants
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-Me (Automated Delivery)
n=59 Participants
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 (Medical Assistants)
n=48 Participants
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 (Combined: Automated Delivery and Medical Assistants)
n=107 Participants
Dulce Digital-Me (Combination of two intervention groups: Automated Delivery and Medical Assistants)
|
|---|---|---|---|---|
|
Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment
|
16.68 score on a scale
Standard Deviation 4.23
|
16.25 score on a scale
Standard Deviation 4.26
|
15.85 score on a scale
Standard Deviation 3.88
|
16.08 score on a scale
Standard Deviation 4.08
|
Adverse Events
Dulce Digital
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dulce Digital-Me (Automated Delivery)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dulce Digital-Me (Medical Assistant)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Athena Philis-Tsimikas, MD, Co-Principal Investigator
Scripps Health
Phone: 858-678-7045
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place