Digital Diabetes Self-Management for Diabetes

(Dulce Digital Trial)

Recruiting at 1 trial location

Overseen By Monica Ruiz, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scripps Whittier Diabetes Institute

Disqualifiers: Severe illness, Liver issues, Anemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to help people manage Type 2 diabetes using digital tools. It compares traditional in-person classes with two digital options: live telehealth sessions (Project Dulce Telehealth) and supportive text messages (Dulce Digital Text-Based Education). The goal is to determine which method best improves diabetes management and access to health information. This trial may suit Hispanic/Latino adults registered with Scripps Health who have had Type 2 diabetes with an HbA1c of 8% or higher in the past two months. As an unphased trial, it offers participants the chance to explore innovative diabetes management strategies that could enhance their health and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these digital diabetes self-management methods are safe?

Research has shown that the treatments tested in the "Dulce Digital 2.0" trial have been safe and well-received in past studies. Dulce Digital, a simple text messaging program, proved very popular among high-risk individuals, especially Hispanic people with type 2 diabetes. Participants appreciated the ease of receiving educational messages that aided in diabetes management.

For the Project Dulce Telehealth approach, earlier studies demonstrated significant improvements in diabetes management and knowledge among high-risk patients. Telehealth, which involves receiving healthcare services remotely, has been effective and well-received in managing diabetes symptoms.

Regarding Project Dulce Live, past research indicates it effectively improved diabetes control and related health outcomes in diverse, underserved communities.

These findings suggest that the digital tools and live education methods in this trial are well-tolerated and have successfully helped people manage their diabetes. While no serious side effects have been noted in these studies, discussing any concerns or potential side effects with the trial coordinators before participating is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to manage diabetes through digital and telehealth methods. Unlike traditional diabetes management, which often involves in-person appointments and manual tracking, the Dulce Digital Text-Based Education program offers a convenient, text-based system for education and support. This approach aims to enhance self-management behaviors and clinical outcomes by delivering timely information directly to patients' phones. Project Dulce Live and Project Dulce Telehealth offer peer-led education and support via live and telehealth sessions, providing a more interactive and accessible experience. These methods could revolutionize diabetes care by making it more flexible and tailored to individual needs.

What evidence suggests that this trial's treatments could be effective for diabetes?

Research shows that the Dulce Digital Text-Based Education program, a treatment arm in this trial, can help people manage diabetes more effectively. In past studies, participants who received motivational and educational text messages controlled their blood sugar levels better, experiencing a noticeable drop in hemoglobin A1C, a key measure of blood sugar control.

For Project Dulce Telehealth, another treatment arm in this trial, studies have demonstrated its effectiveness in enhancing diabetes care and understanding. Participants showed significant improvements in managing their blood sugar levels.

Similarly, Project Dulce Live, the third treatment arm in this trial, includes peer-led education and has helped participants improve their blood sugar and overall health. Those in the program experienced significant health benefits compared to non-participants. ^{1 3 6 7 8}

Who Is on the Research Team?

Athena Philis-Tsimikas, MD

Principal Investigator

Scripps Health

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latino adults with Type 2 Diabetes, registered at Scripps Health, and an HbA1c level ≥8% in the last 60 days. It's not for those with recent substance abuse issues, severe health problems like anemia or liver dysfunction, minimal literacy, or who don't speak Spanish/English.

Inclusion Criteria

I have been diagnosed with Type 2 Diabetes.

Adults who are Hispanic/Latino and are patients at Scripps Health.

Your blood sugar level (HbA1c) has been higher than 8% in the last two months.

Exclusion Criteria

I am not willing to carry a mobile phone.

History of drug or alcohol abuse within 12 months prior to randomization

I am too ill to visit the clinic for treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in diabetes self-management education through digital platforms, including telehealth group visits, text-based messages, and live delivery

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Dulce Digital Text-Based Education
• Project Dulce Live
• Project Dulce Telehealth

Trial Overview Dulce Digital 2.0 evaluates two digital adaptations of Project Dulce aimed at improving diabetes self-management via text messages and telehealth platforms compared to traditional in-person education.

How Is the Trial Designed?

Group I: Project Dulce Telehealth DSME/S Experimental Treatment 1 Intervention

Patients will participate in live a peer-led Telehealth diabetes self-management education and support program.

Group II: Project Dulce Live DSME/S Experimental Treatment 1 Intervention

Patients will participate in live a peer-led Telehealth diabetes self-management education and support program.

Group III: Dulce Digital Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Scripps Whittier Diabetes Institute

Lead Sponsor

Trials

19

Recruited

5,400+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39707158/

Dulce Digital-Me: results of a randomized comparative trial of ... This study compared the effectiveness of a static, text-based DSME/S intervention (Dulce Digital, DD) versus a dynamic approach with personalized feedback and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5606313/

Dulce Digital: An mHealth SMS-Based Intervention Improves ... Dulce Digital participants received up to three motivational, educational, and/or call-to-action text messages per day over 6 months. The primary outcome was ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168822724000986

Outcomes of the Dulce Digital-COVID Aware (DD-CA) ... Previous studies have shown that diabetes self-management education and support (DSME/S) improves glycemic control, reducing glycosylated hemoglobin (HbA1c) ...

4. researchgate.net researchgate.net/publication/396712099_Dulce_Digital_20_-_Innovative_Diabetes_Self-Management_in_the_Digital_Age

Dulce Digital 2.0 - Innovative Diabetes Self-Management in ... Previous studies of Project Dulce have shown a significant improvement in clinical diabetes care, self-awareness, and understanding of diabetes ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05899-x

Dulce Digital-Me: protocol for a randomized controlled trial ... The primary aim is to compare the effectiveness of Dulce Digital, Dulce Digital-Me-Automated, and Dulce Digital-Me-Telephonic in improving ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03130699

Dulce Digital-Me: An Adaptive mHealth Intervention for ... This study will compare Dulce Digital (i.e., the investigators' proven-effective combination of "one-size-fits-all" educational text messages and nurse ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8796443/

Dulce Digital-Me: protocol for a randomized controlled trial ... The study will examine the comparative effectiveness of the three groups in improving diabetes clinical control [HbA1c, primary outcome; low- ...

8. diabetesresearchclinicalpractice.com diabetesresearchclinicalpractice.com/article/S0168-8227(24)00098-6/abstract

Outcomes of the Dulce Digital-COVID Aware (DD-CA) ... DD-CA includes diabetes educational messaging with additional COVID-safe messaging (e.g., promoting masking; social distancing; vaccination). Findings. Among ...