Diabetes Mellitus, Type 2DD-MeNCT03130699

Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes

A study testing Dulce Digital, Dulce Digital-Me (Automated Delivery) and Dulce Digital-Me (Medical Assistant) in people with Diabetes Mellitus, Type 2, run by Scripps Whittier Diabetes Institute at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Dulce Digital, Dulce Digital-Me (Automated Delivery) and Dulce Digital-Me (Medical Assistant)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 310 participants
Where: 2 sitesUnited States
Study dates: 31 Oct 2017to 14 Aug 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Self-identified Hispanic/Latino
18 years or older
Registered patient of a Neighborhood Healthcare Clinic
Diagnosed with T2DM (Type 2 Diabetes Mellitus)
HbA1c ≥ 8.0% and/or SBP ≥ 160 mmHg, and/or LDL-C ≥ 100 mg/dL in the last 30 days

Who cannot join

Severe illness precluding regular clinic visits
Pregnant or lactating
Type 1 or gestational diabetes
Lack of minimal literacy
Plans to relocate
Severe auditory or visual problems
Primary language other than Spanish or English
Unwilling to carry a mobile phone

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Scripps Mercy Chula Vista
Chula Vista, California, 91910
Scripps Whittier Diabetes Institute
La Jolla, California, 92037

Other trials in United States

About this study

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.

Read the 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.

Conditions: Diabetes Mellitus, Type 2
Being tested: Dulce Digital, Dulce Digital-Me (Automated Delivery), Dulce Digital-Me (Medical Assistant)
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
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dulce DigitalBehavioural
One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.
Dulce Digital-Me (Automated Delivery)Behavioural
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)Behavioural
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.

Study groups in NCT03130699
Study group	Role	What they receive
Dulce Digital	Experimental	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. Receives: Behavioral: Dulce Digital
Dulce Digital-Me (Automated Delivery)	Experimental	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. Receives: Behavioral: Dulce Digital-Me (Automated Delivery)
Dulce Digital-Me (Medical Assistant)	Experimental	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. Receives: Behavioral: Dulce Digital-Me (Medical Assistant)

What is being measured

The primary outcome is the main question the study is designed to answer.

Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment
Glycosylated Hemoglobin (HbA1c) six months after enrollment
Measured: 6 months from baseline
Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment
Glycosylated Hemoglobin (HbA1c) twelve months after enrollment
Measured: 12 months from baseline
Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment
Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment
Measured: 6 months from baseline
Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment
Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment
Measured: 12 months from baseline
Systolic Blood Pressure (SBP); 6 Months From Enrollment
Systolic blood pressure (SBP); six months from enrollment
Measured: 6 months from baseline
Systolic Blood Pressure (SBP); 12 Months From Enrollment
Systolic blood pressure (SBP); twelve months from enrollment
Measured: 12 months from baseline

Secondary outcomes (16)

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.
Measured: 6 months from baseline
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.
Measured: 12 months from baseline
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.
Measured: 6 months from baseline
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.
Measured: 12 months from baseline
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.
Measured: 6 months from baseline
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.
Measured: 12 months from baseline
Participated in Strength Exercise; 6 Months From Enrollment
Participated in Strength Exercise as reported by patient; six months from enrollment
Measured: 6 months from baseline
Participated in Strength Exercise; 12 Months From Enrollment
Participated in Strength Exercise as reported by patient; twelve months from enrollment
Measured: 12 months from baseline
Participated in Flexibility Exercise; 6 Months From Enrollment
Participated in Flexibility Exercise as reported by patient; six months from enrollment
Measured: 6 months from baseline
Participated in Flexibility Exercise; 12 Months From Enrollment
Participated in Flexibility Exercise as reported by patient; twelve months from enrollment
Measured: 12 months from baseline
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.
Measured: 6 months from baseline
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.
Measured: 12 months from baseline
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.
Measured: 6 months from baseline
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.
Measured: 12 months from baseline
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.
Measured: 6 months from baseline
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.
Measured: 12 months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Oct 201714 Aug 2021

First posted26 Apr 2017
Study start31 Oct 2017
Primary completion14 Aug 2021
Study completion14 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 310 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03130699
Sponsor's protocol ID: R01DK112322-01A1
Acronym: DD-Me
Status last verified: Jun 2025
First submitted: 24 Apr 2017
Last updated: 25 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Philis-Tsimikas A, Fortmann AL, Clark T, Spierling Bagsic SR, Farcas E, Roesch SC, Schultz J, Gilmer TP, Godino JG, Savin KL, Chichmarenko M, Jones JA, Sandoval H, Gallo LC. Dulce Digital-Me: results of a randomized comparative trial of static versus adaptive digital interventions for Latine adults with diabetes. Ann Behav Med. 2025 Jan 4;59(1):kaae077. doi: 10.1093/abm/kaae077.
PubMed 39707158
Philis-Tsimikas A, Fortmann AL, Godino JG, Schultz J, Roesch SC, Gilmer TP, Farcas E, Sandoval H, Savin KL, Clark T, Chichmarenko M, Jones JA, Gallo LC. Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes. Trials. 2022 Jan 28;23(1):80. doi: 10.1186/s13063-021-05899-x.
PubMed 35090520

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dulce Digital-Me: An Adaptive mHealth Intervention for Underserved Hispanics With Diabetes
ClinicalTrials.gov ID: NCT03130699
Acronym / sponsor ID: DD-Me / R01DK112322-01A1
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes, mHealth, Medical Assistant, Automated, Adaptive Feedback, Self-Management Support, Hispanics, HbA1c
Study type: Interventional
Recruitment status: Completed
Enrolment: 310 participants (actual)
Lead sponsor: Scripps Whittier Diabetes InstituteUniversity, hospital or other
Collaborators: University of California, San Diego, San Diego State University
Study start: 31 Oct 2017 (actual)
Primary completion: 14 Aug 2021 (actual)
Study completion: 14 Aug 2021 (actual)
First posted: 26 Apr 2017 (actual)
Results: Posted 25 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Dulce Digital	Experimental	Behavioral: Dulce DigitalThe 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)	Experimental	Behavioral: 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 (Medical Assistant)	Experimental	Behavioral: 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Self-identified Hispanic/Latino
18 years or older
Registered patient of a Neighborhood Healthcare Clinic
Diagnosed with T2DM (Type 2 Diabetes Mellitus)
HbA1c ≥ 8.0% and/or SBP ≥ 160 mmHg, and/or LDL-C ≥ 100 mg/dL in the last 30 days

Key exclusion criteria (8 listed)

Severe illness precluding regular clinic visits
Pregnant or lactating
Type 1 or gestational diabetes
Lack of minimal literacy
Plans to relocate

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dulce DigitalOne-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.	Behavioural	Dulce Digital
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.	Behavioural	Dulce Digital-Me (Automated Delivery)
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.	Behavioural	Dulce Digital-Me (Medical Assistant)

Primary outcome

Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment
Time frame: 6 months from baseline
Glycosylated Hemoglobin (HbA1c) six months after enrollment
Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment
Time frame: 12 months from baseline
Glycosylated Hemoglobin (HbA1c) twelve months after enrollment
Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment
Time frame: 6 months from baseline
Low-density lipoprotein-cholesterol (LDL-C); six months after enrollment
Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment
Time frame: 12 months from baseline
Low-density lipoprotein-cholesterol (LDL-C); twelve months after enrollment
Systolic Blood Pressure (SBP); 6 Months From Enrollment
Time frame: 6 months from baseline
Systolic blood pressure (SBP); six months from enrollment
Systolic Blood Pressure (SBP); 12 Months From Enrollment
Time frame: 12 months from baseline
Systolic blood pressure (SBP); twelve months from enrollment

16 secondary outcomes

Patient-Provider Communication; 6 Months From Enrollment
Time frame: 6 months from baseline
Patient-Provider Communication; 12 Months From Enrollment
Time frame: 12 months from baseline
Patient Blood Glucose Monitoring; 6 Months From Enrollment
Time frame: 6 months from baseline
Patient Blood Glucose Monitoring; 12 Months From Enrollment
Time frame: 12 months from baseline
Participated in Aerobic Exercise; 6 Months From Enrollment
Time frame: 6 months from baseline
Participated in Aerobic Exercise; 12 Months From Enrollment
Time frame: 12 months from baseline
Participated in Strength Exercise; 6 Months From Enrollment
Time frame: 6 months from baseline
Participated in Strength Exercise; 12 Months From Enrollment
Time frame: 12 months from baseline
Participated in Flexibility Exercise; 6 Months From Enrollment
Time frame: 6 months from baseline
Participated in Flexibility Exercise; 12 Months From Enrollment
Time frame: 12 months from baseline
Healthy Eating Behaviors; 6 Months From Enrollment
Time frame: 6 months from baseline
Healthy Eating Behaviors; 12 Months From Enrollment
Time frame: 12 months from baseline
Diabetes Distress; 6 Months From Enrollment
Time frame: 6 months from baseline
Diabetes Distress; 12 Months From Enrollment
Time frame: 12 months from baseline
Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 6 Months From Enrollment
Time frame: 6 months from baseline
Adherence to Refills and Medications Scale (ARMS) - Patient-reported Outcome; 12 Months From Enrollment
Time frame: 12 months from baseline

Results and safety

Results posted to the registry on 25 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dulce Digital	107	67
Dulce Digital-Me (Automated Delivery)	106	66
Dulce Digital-Me (Medical Assistant)	97	65

Primary outcome: Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment

Time frame: 6 months from baseline. Mean (Standard Deviation). Unit: percentage

Measure	Dulce Digital n = 77	Dulce Digital-Me (Automated Delivery) n = 76	Dulce Digital-Me (Medical Assistants) n = 73	Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) n = 149
Value	8.17 (1.51)	7.99 (1.61)	8.44 (1.48)	8.21 (1.56)

Dulce Digital vs Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants): p = 0.95, Regression, Logistic

Population analysed: Participants that came in for 6-month measures

Primary outcome: Glycosylated Hemoglobin (HbA1c) 12 Months After Enrollment

Time frame: 12 months from baseline. Mean (Standard Deviation). Unit: percentage

Measure	Dulce Digital n = 67	Dulce Digital-Me (Automated Delivery) n = 66	Dulce Digital-Me (Medical Assistants) n = 65	Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) n = 131
Value	8.29 (1.62)	8.41 (1.70)	8.83 (1.83)	8.62 (1.77)

Dulce Digital vs Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants): p = 0.37, Regression, Logistic

Population analysed: Participants that came in for 12-month measures

Primary outcome: Low-density Lipoprotein-cholesterol (LDL-C); 6 Months After Enrollment

Time frame: 6 months from baseline. Mean (Standard Deviation). Unit: mg/dL

Measure	Dulce Digital n = 60	Dulce Digital-Me (Automated Delivery) n = 56	Dulce Digital-Me (Medical Assistants) n = 58	Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) n = 174
Value	90.27 (33.66)	88.20 (36.38)	102.93 (47.96)	95.69 (43.12)

Dulce Digital vs Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants): p = 0.26, Regression, Logistic

Population analysed: Participants

Primary outcome: Low-density Lipoprotein-cholesterol (LDL-C); 12 Months After Enrollment

Time frame: 12 months from baseline. Mean (Standard Deviation). Unit: mg/dL

Measure	Dulce Digital n = 41	Dulce Digital-Me (Automated Delivery) n = 49	Dulce Digital-Me (Medical Assistants) n = 48	Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants) n = 138
Value	97.85 (27.74)	94.10 (35.18)	92.04 (43.23)	93.08 (39.18)

Dulce Digital vs Dulce Digital-Me (Combined: Automated Delivery and Medical Assistants): p = 0.90, Regression, Logistic

Population analysed: Participants

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of individual patient recruitment at baseline through the end of month 12.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dulce Digital	0 of 107 (0%)	0 of 107 (0%)	0 of 107
Dulce Digital-Me (Automated Delivery)	0 of 106 (0%)	0 of 106 (0%)	0 of 106
Dulce Digital-Me (Medical Assistant)	0 of 97 (0%)	0 of 97 (0%)	1 of 97

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39707158Philis-Tsimikas A, Fortmann AL, Clark T, Spierling Bagsic SR, Farcas E, Roesch SC, Schultz J, Gilmer TP, Godino JG, Savin KL, Chichmarenko M, Jones JA, Sandoval H, Gallo LC. Dulce Digital-Me: results of a randomized comparative trial of static versus adaptive digital interventions for Latine adults with diabetes. Ann Behav Med. 2025 Jan 4;59(1):kaae077. doi: 10.1093/abm/kaae077.
Derived from this study: PubMed 35090520Philis-Tsimikas A, Fortmann AL, Godino JG, Schultz J, Roesch SC, Gilmer TP, Farcas E, Sandoval H, Savin KL, Clark T, Chichmarenko M, Jones JA, Gallo LC. Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes. Trials. 2022 Jan 28;23(1):80. doi: 10.1186/s13063-021-05899-x.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Athena Philis-Tsimikas, MD principal investigator

Scripps Whittier Diabetes Institute

Linda Gallo, PhD principal investigator

San Diego State University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycosylated Hemoglobin (HbA1c) 6 Months After Enrollment (time frame: 6 months from baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03130699, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.