Diabetes Type 2Dulce DigitalNCT05416060
Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age
A study testing Dulce Digital Text-Based Education, Project Dulce Telehealth and Project Dulce Live in people with Diabetes Type 2, run by Scripps Whittier Diabetes Institute at 2 sites in United States.
Trial summary
The proposed research, "Dulce Digital 2.0," will evaluate two mHealth adaptions of Project Dulce that are designed to improve digital health literacy, increase underserved individuals' capacity to access and engage with vital digital health information, and in turn, improve clinical and behavioral outcomes in at-risk… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Dulce Digital Text-Based Education, Project Dulce Telehealth and Project Dulce Live
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Mar 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Hispanic/Latino adults who are registered patients of Scripps Health
- Diagnosis of Type 2 Diabetes
- HbA1c greater than or equal to 8% within the last 60 days
Who cannot join
- Severe illness precluding visits to clinic
- Liver function tests (ALT and AST) > 3 times the upper limit of normal
- Body mass index ≤ 23 kg/cm
- History of malignancy, except subjects who have been disease-free for >2 years, or whose only malignancy has been basal or squamous cell skin carcinoma
- Creatinine >3.5
- History of drug or alcohol abuse within 12 months prior to randomization
Show all 15Show fewer
- Current enrollee in DSME/S
- Blood donation of one pint or more within the past 30 days, or plasma donation within 7 days prior to screening
- Anemia
- Lack of minimal literacy needed to participate in the text intervention
- Severe auditory or visual problems
- Primary language other than Spanish or English
- Not willing to carry a mobile phone
- Pregnant
- Plans to relocate
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Scripps Chula Vista Diabetes Center
Chula Vista, California, 91910
Athena Philis-Tsimikas, MD, 858-678-7046
Monica Ruiz, MA, 619-813-6747
- Recruiting
Scripps Whittier Diabetes Institute
San Diego, California, 92121
Athena Philis-Tsimikas, MD, 858-678-7046
Monica Ruiz, MA, 619-813-6747
About this study
The proposed research, "Dulce Digital 2.0," will evaluate two mHealth adaptions of Project Dulce that are designed to improve digital health literacy, increase underserved individuals' capacity to access and engage with vital digital health information, and in turn, improve clinical and behavioral outcomes in at-risk adults with diabetes. Expanding access to care in populations faced with challenges of low socioeconomic status and health literacy is a step toward reducing health disparities and positively affecting care. The literature shows that identifying which groups of participants are most likely to benefit from telehealth interventions is an important factor in improving the evidence base for digital health literacy. Dulce Digital 2.0 is highly scalable once the technical infrastructure is built. More importantly, by helping to reduce existing inequities in access to diabetes care and accurate digital health information the model could help to improve health outcomes on a larger scale. The use of digital technology in the delivery of healthcare interventions is increasingly common. Barriers to engagement in digital technology exist among those in underserved populations due to language, access to equipment and internet, education level, exposure to and comfort with technology, and pre-existing deficits in health literacy. The proposed research will investigate the effectiveness of two digital approaches to improving the self-management and digital health skills of underserved participants with diabetes compared to tradition in-person self-management education: 1) live self-management education, traditional in-person classes; 2) live self-management education using a telehealth distance learning platform; and 3) a series of text-based messages, not requiring a smart phone or internet connection, that encourage healthy self-management behaviors.
Read the detailed description
Diabetes self-management education using digital platforms including, telehealth group visits, text-based messages and live delivery will result in improvements in diabetes health behaviors, patient engagement, health literacy and HbA1c.
Diabetes disproportionately affects racial and ethnic communities. The investigator developed Project Dulce, an American Diabetes Association-recognized and Medicare-approved Diabetes Self-Management Education and Support (DSME/S) program addresses the needs of a racially and ethnically diverse San Diego population and includes a multi-disciplinary team with peer educators delivering DSME/S. Previous trials have shown Project Dulce team-care improves clinical management and reduces costs and that the peer education alone improves clinical outcomes in Hispanics with Type 2 Diabetes across 10 months.
Mobile health (mHealth) technologies represent a viable way to overcome many of these barriers and extend the reach of DSME/S to participants who need it most.
During the coronavirus disease (COVID-19) pandemic, Project Dulce was adapted for group telehealth settings and delivered via the electronic medical record (EMR) scheduling system. Additionally, a previously developed text messaging platform-Dulce Digital was offered to extend the reach of the care team through educational and motivational messaging, medication reminders, and blood glucose monitoring prompts. A previous randomized controlled trial of Dulce Digital demonstrated a significant reduction of HbA1c across 10 months versus usual care in Hispanics with diabetes. While live Project Dulce and Dulce Digital programs have demonstrated improvements in clinical and cost outcomes in Hispanic patients, a comparative analysis of live, group telehealth and text messaging programs has not been done. This study will assess a direct comparison of each of these modalities to explore the feasibility, acceptance, and effectiveness of each delivery modality across Hispanic communities living with type 2 diabetes.
- Conditions
- Diabetes Type 2
- Being tested
- Dulce Digital Text-Based Education, Project Dulce Telehealth, Project Dulce Live
- Keywords
- Diabetes, Health Education, mHealth Technology, Group Education, Telehealth, Text-Based
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dulce Digital Text-Based EducationBehavioural
Participants will be enrolled in the digital texting platform, Dulce Digital in which they will receive on-going support via text messages for 6 months, derived from the Project Dulce curriculum. Topics include medication reminders, motivational prompts, nutrition and stress reduction tips and request to submit weekly blood glucose numbers.
Project Dulce TelehealthBehavioural
Project Dulce will consist of a group-based telehealth diabetes self-management education program consisting of a 5 -week curriculum delivered by a peer educator in English or Spanish. The curriculum provides skills and tools needed to adapt to a life with diabetes and change behaviors. The curriculum covers diabetes and its complications, the role of diet, exercise, and medication, and the importance of self-monitoring. It is presented over 5 weeks where participants learn and practice self-management skills, and help one another address family, cultural or health system barriers to managing your diabetes.
Project Dulce LiveBehavioural
Project Dulce will consist of a group-based diabetes self-management education program consisting of a 5 -week curriculum delivered by a peer educator in English or Spanish. The curriculum provides skills and tools needed to adapt to a life with diabetes and change behaviors. The curriculum covers diabetes and its complications, the role of diet, exercise, and medication, and the importance of self-monitoring. It is presented over 5 weeks where participants learn and practice self-management skills, and help one another address family, cultural or health system barriers to managing your diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Dulce Digital | Experimental | Patients will participate in a text-based diabetes self-management educational and support (DSME/S) program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes. Receives: Behavioral: Dulce Digital Text-Based Education |
| Project Dulce Telehealth DSME/S | Experimental | Patients will participate in live a peer-led Telehealth diabetes self-management education and support program. Receives: Behavioral: Project Dulce Telehealth |
| Project Dulce Live DSME/S | Experimental | Patients will participate in live a peer-led Telehealth diabetes self-management education and support program. Receives: Behavioral: Project Dulce Live |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months; % Units HbA1c is measure of blood sugar level and assessed using blood samples following a 12-hour fast. Samples will be process by Quest Diagnostics Inc and assayed by Immunoturbidimetry (integra 800, Roche). Higher is worse.
Measured: 3 months
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months; % Units HbA1c is measure of blood sugar level and assessed using blood samples following a 12-hour fast. Samples will be process by Quest Diagnostics Inc and assayed by Immunoturbidimetry (integra 800, Roche). Higher is worse.
Measured: 6 months
Secondary outcomes (4)
Change from Baseline Diabetes Distress (DDS-17) at 3 months
The Diabetes Distress Scale (DDS-17) is a self-report instrument for adults with type 2 diabetes. The scaled yields an overall distress score based on the average of response on the 1-6 scale for all 17 items. The DDS-17 identifies three levels of specificity of diabetes distress information for use in clinical care, from overall emotional distress related to diabetes to highly specific sources of diabetes distress. Higher score is worse.
Measured: 3 months
Change from Baseline Diabetes Distress (DDS-17) at 6 months
The Diabetes Distress Scale (DDS-17) is a self-report instrument for adults with type 2 diabetes. The scaled yields an overall distress score based on the average of response on the 1-6 scale for all 17 items. The DDS-17 identifies three levels of specificity of diabetes distress information for use in clinical care, from overall emotional distress related to diabetes to highly specific sources of diabetes distress.
Measured: 6 months
Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 3 months
The DTSQ scale has been shown to be useful in clinical trials evaluation of new technologies and has been used as one outcome indicator in routine audit diabetes care. It is composed of 8 questions, scored by patients on a scale ranging from 0 ("very dissatisfied", "very inconvenient") to 6 ("very satisfied", "very convenient"). It is composed of 2 factors. The first factor assesses treatment satisfaction (6 questions). These questions ask about "satisfaction with current treatment", "flexibility", "convenience", "understanding of diabetes", "recommend treatment to others" and "willingness to continue", respectively. The second factor (2 questions) which assess the burden from hyper- and hypoglycemia, respectively (0 "none of the time" to 6 "most of the time"). Treatment satisfaction is assessed as the sum of scores of 6 questions on the first factor (total score 36). A higher score indicates higher treatment satisfaction.
Measured: 3 months
Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 6 months
The DTSQ scale has been shown to be useful in clinical trials evaluation of new technologies and has been used as one outcome indicator in routine audit diabetes care. It is composed of 8 questions, scored by patients on a scale ranging from 0 ("very dissatisfied", "very inconvenient") to 6 ("very satisfied", "very convenient"). It is composed of 2 factors. The first factor assesses treatment satisfaction (6 questions). These questions ask about "satisfaction with current treatment", "flexibility", "convenience", "understanding of diabetes", "recommend treatment to others" and "willingness to continue", respectively. The second factor (2 questions) which assess the burden from hyper- and hypoglycemia, respectively (0 "none of the time" to 6 "most of the time"). Treatment satisfaction is assessed as the sum of scores of 6 questions on the first factor (total score 36). A higher score indicates higher treatment satisfaction.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start23 Mar 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a three-arm, non-blinded, randomized, controlled, parallel-groups, comparative effectiveness trial with N=150 participants. The protocol was developed in accordance with Good Clinical Practice, SPIRIT, and CONSORT 2013 guidelines.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Whittier Diabetes Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Athena Philis-Tsimikas, MD, Principal investigator, Scripps Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416060
- Sponsor's protocol ID
- MISP-60691
- Other IDs
- MISP-60691
- Acronym
- Dulce Digital
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2022
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dulce Digital 2.0 - Innovative Diabetes Self-Management in the Digital Age
- ClinicalTrials.gov ID
- NCT05416060
- Acronym / sponsor ID
- Dulce Digital / MISP-60691
- Conditions
- Diabetes Type 2
- Keywords
- Diabetes, Health Education, mHealth Technology, Group Education, Telehealth, Text-Based
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Scripps Whittier Diabetes InstituteUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research, "Dulce Digital 2.0," will evaluate two mHealth adaptions of Project Dulce that are designed to improve digital health literacy, increase underserved individuals' capacity to access and engage with vital digital health information, and in turn, improve clinical and behavioral outcomes in at-risk adults with diabetes. Expanding access to care in populations faced with challenges of low socioeconomic status and health literacy is a step toward reducing health disparities and positively affecting care. The literature shows that identifying which groups of participants are most likely to benefit from telehealth interventions is an important factor in improving the evidence base for digital health literacy. Dulce Digital 2.0 is highly scalable once the technical infrastructure is built. More importantly, by helping to reduce existing inequities in access to diabetes care and accurate digital health information the model could help to improve health outcomes on a larger scale. The use of digital technology in the delivery of healthcare interventions is increasingly common. Barriers to engagement in digital technology exist among those in underserved populations due to language, access to equipment and internet, education level, exposure to and comfort with technology, and pre-existing deficits in health literacy. The proposed research will investigate the effectiveness of two digital approaches to improving the self-management and digital health skills of underserved participants with diabetes compared to tradition in-person self-management education: 1) live self-management education, traditional in-person classes; 2) live self-management education using a telehealth distance learning platform; and 3) a series of text-based messages, not requiring a smart phone or internet connection, that encourage healthy self-management behaviors.
Detailed description
Diabetes self-management education using digital platforms including, telehealth group visits, text-based messages and live delivery will result in improvements in diabetes health behaviors, patient engagement, health literacy and HbA1c.
Diabetes disproportionately affects racial and ethnic communities. The investigator developed Project Dulce, an American Diabetes Association-recognized and Medicare-approved Diabetes Self-Management Education and Support (DSME/S) program addresses the needs of a racially and ethnically diverse San Diego population and includes a multi-disciplinary team with peer educators delivering DSME/S. Previous trials have shown Project Dulce team-care improves clinical management and reduces costs and that the peer education alone improves clinical outcomes in Hispanics with Type 2 Diabetes across 10 months.
Mobile health (mHealth) technologies represent a viable way to overcome many of these barriers and extend the reach of DSME/S to participants who need it most.
During the coronavirus disease (COVID-19) pandemic, Project Dulce was adapted for group telehealth settings and delivered via the electronic medical record (EMR) scheduling system. Additionally, a previously developed text messaging platform-Dulce Digital was offered to extend the reach of the care team through educational and motivational messaging, medication reminders, and blood glucose monitoring prompts. A previous randomized controlled trial of Dulce Digital demonstrated a significant reduction of HbA1c across 10 months versus usual care in Hispanics with diabetes. While live Project Dulce and Dulce Digital programs have demonstrated improvements in clinical and cost outcomes in Hispanic patients, a comparative analysis of live, group telehealth and text messaging programs has not been done. This study will assess a direct comparison of each of these modalities to explore the feasibility, acceptance, and effectiveness of each delivery modality across Hispanic communities living with type 2 diabetes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a three-arm, non-blinded, randomized, controlled, parallel-groups, comparative effectiveness trial with N=150 participants. The protocol was developed in accordance with Good Clinical Practice, SPIRIT, and CONSORT 2013 guidelines.
| Arm | Type | Receives |
|---|---|---|
| Dulce Digital | Experimental | Behavioral: Dulce Digital Text-Based EducationPatients will participate in a text-based diabetes self-management educational and support (DSME/S) program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes. |
| Project Dulce Telehealth DSME/S | Experimental | Behavioral: Project Dulce TelehealthPatients will participate in live a peer-led Telehealth diabetes self-management education and support program. |
| Project Dulce Live DSME/S | Experimental | Behavioral: Project Dulce LivePatients will participate in live a peer-led Telehealth diabetes self-management education and support program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hispanic/Latino adults who are registered patients of Scripps Health
- Diagnosis of Type 2 Diabetes
- HbA1c greater than or equal to 8% within the last 60 days
Key exclusion criteria (15 listed)
- Severe illness precluding visits to clinic
- Liver function tests (ALT and AST) > 3 times the upper limit of normal
- Body mass index ≤ 23 kg/cm
- History of malignancy, except subjects who have been disease-free for >2 years, or whose only malignancy has been basal or squamous cell skin carcinoma
- Creatinine >3.5
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 Digital Text-Based EducationParticipants will be enrolled in the digital texting platform, Dulce Digital in which they will receive on-going support via text messages for 6 months, derived from the Project Dulce curriculum. Topics include medication reminders, motivational prompts, nutrition and stress reduction tips and request to submit weekly blood glucose numbers. | Behavioural | Dulce Digital |
| Project Dulce TelehealthProject Dulce will consist of a group-based telehealth diabetes self-management education program consisting of a 5 -week curriculum delivered by a peer educator in English or Spanish. The curriculum provides skills and tools needed to adapt to a life with diabetes and change behaviors. The curriculum covers diabetes and its complications, the role of diet, exercise, and medication, and the importance of self-monitoring. It is presented over 5 weeks where participants learn and practice self-management skills, and help one another address family, cultural or health system barriers to managing your diabetes. | Behavioural | Project Dulce Telehealth DSME/S |
| Project Dulce LiveProject Dulce will consist of a group-based diabetes self-management education program consisting of a 5 -week curriculum delivered by a peer educator in English or Spanish. The curriculum provides skills and tools needed to adapt to a life with diabetes and change behaviors. The curriculum covers diabetes and its complications, the role of diet, exercise, and medication, and the importance of self-monitoring. It is presented over 5 weeks where participants learn and practice self-management skills, and help one another address family, cultural or health system barriers to managing your diabetes. | Behavioural | Project Dulce Live DSME/S |
Primary outcome
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months
Time frame: 3 months
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months; % Units HbA1c is measure of blood sugar level and assessed using blood samples following a 12-hour fast. Samples will be process by Quest Diagnostics Inc and assayed by Immunoturbidimetry (integra 800, Roche). Higher is worse.
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months
Time frame: 6 months
Change in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 6 months; % Units HbA1c is measure of blood sugar level and assessed using blood samples following a 12-hour fast. Samples will be process by Quest Diagnostics Inc and assayed by Immunoturbidimetry (integra 800, Roche). Higher is worse.
4 secondary outcomes
Change from Baseline Diabetes Distress (DDS-17) at 3 months
Time frame: 3 months
Change from Baseline Diabetes Distress (DDS-17) at 6 months
Time frame: 6 months
Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 3 months
Time frame: 3 months
Change from Baseline Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Athena Philis-Tsimikas, MD principal investigator
Scripps Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dulce Digital Text-Based Education, Project Dulce Telehealth and Project Dulce Live in people with Diabetes Type 2, run by Scripps Whittier Diabetes Institute at 2 sites in United States.
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 3 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Athena Philis-Tsimikas, MD (858-678-7046, philis-tsimikas.athena@scrippshealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Baseline Glycosylated Hemoglobin A1C (HbA1c) at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2026.