Project Dulce + Dulce Digital for Type 2 Diabetes

Recruiting at 2 trial locations

Overseen By Athena Philis-Tsimikas, MD

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)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help Filipino Americans with type 2 diabetes manage their health through a culturally adapted program called Project Dulce + Dulce Digital, combined with text message support. The goal is to enhance participants' knowledge about diabetes, attitudes, and self-care habits over three and six months. It targets Filipino Americans diagnosed with type 2 diabetes who can communicate in English and Tagalog and have access to a cell phone for receiving text messages. Participants should have high blood sugar, blood pressure, or cholesterol levels and be registered, or willing to register, at Scripps Health or San Ysidro Health. As an unphased trial, this study provides a unique opportunity to contribute to research tailored to the community's needs.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this program is safe for Filipino Americans with type 2 diabetes?

Research shows that Project Dulce and Dulce Digital are safe and well-tolerated programs for managing type 2 diabetes. Past studies have adapted Project Dulce for various cultural groups, such as Arab Americans, without major safety concerns. The program emphasizes education and peer support, which are generally safe methods.

Studies on Dulce Digital, a text messaging program, indicate it is both acceptable and affordable. It has been used with high-risk Hispanic individuals with type 2 diabetes, where it was well-received and caused no negative effects. These findings suggest that the combined Project Dulce + Dulce Digital program is likely safe for Filipino Americans with type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Project Dulce + Dulce Digital for type 2 diabetes because it combines a peer-led education approach with digital support to enhance self-management. Unlike traditional treatments that often focus on medication management or dietary changes, this program empowers patients through group education and continuous text-based support, potentially improving their knowledge and self-care practices. This unique combination aims to foster lasting behavioral changes, which could lead to better long-term health outcomes for individuals with type 2 diabetes.

What evidence suggests that Project Dulce + Dulce Digital is effective for type 2 diabetes?

Research has shown that Project Dulce, when adjusted for cultural differences, improves diabetes management in certain ethnic groups, such as Arab Americans. This program provides diabetes education tailored to cultural and language needs, leading to better blood sugar control. Additionally, Dulce Digital, a text messaging support program, has successfully improved diabetes care for high-risk groups. In previous studies, participants who received these text messages enhanced their understanding and management of diabetes. In this trial, participants will engage in both Project Dulce and Dulce Digital to enhance diabetes knowledge, beliefs, and self-care habits, which are essential for effectively managing type 2 diabetes. ^{1 2 3 4 6}

Who Is on the Research Team?

Emily Rose N. San Diego, PhD

Principal Investigator

Scripps Whittier Diabetes Institute

Are You a Good Fit for This Trial?

This trial is for Filipino-Americans with type 2 diabetes who can speak English and Tagalog, have an HbA1c level of ≥8%, and are registered or willing to register at a community clinic. It's not for those with severe illnesses, certain liver conditions, low body mass index, pregnancy, recent history of cancer (except some skin cancers), high creatinine levels, recent substance abuse issues, non-permanent residents in the area or current enrollees in Project Dulce.

Inclusion Criteria

Registered in the community clinic (or willing to register)

Your HbA1c level is higher than 8% within the last month.

I can speak, read, write, and understand both English and Tagalog.

Exclusion Criteria

Your body mass index is less than or equal to 23.

Your liver function tests show that your ALT and AST levels are more than three times higher than the normal range.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cultural Adaptation and Implementation

Cultural adaptation of Project Dulce and Dulce Digital for Filipino Americans with T2DM, including addressing linguistic challenges, health literacy, and cultural beliefs.

3 months

Ongoing support via text messages

Evaluation

Evaluation of the effectiveness of the adapted program in improving diabetes knowledge, attitudes, beliefs, and self-management behaviors.

6 months

Data collection at baseline, 3 months, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after the main intervention period.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Project Dulce + Dulce Digital

Trial Overview The study tests a culturally adapted diabetes self-management program called Project Dulce combined with a text messaging service named Dulce Digital. The goal is to improve diabetes knowledge and self-care among Filipino Americans by addressing cultural barriers. Effectiveness will be measured through changes in beliefs, attitudes towards diabetes management and hemoglobin A1C levels over 3 to 6 months.

How Is the Trial Designed?

Group I: Project Dulce + Dulce Digital Experimental Treatment 1 Intervention

Patients will participate in a peer-led group diabetes self-management education and support program and receive ongoing support via text messages designed to improve knowledge, health beliefs, self-management behaviors and clinical outcomes.

Project Dulce + Dulce Digital is already approved in United States for the following indications:

Approved in United States as Project Dulce + Dulce Digital for:

• Type 2 Diabetes Mellitus

Who Is Running the Clinical Trial?

Scripps Whittier Diabetes Institute

Lead Sponsor

Trials

19

Recruited

5,400+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

Participants in Project Dulce, a culturally sensitive diabetes management program for Latinos, showed significant improvements in key health markers after one year, including a reduction in HbA1c from 11.5% to 8.3%, indicating better blood sugar control.

The program also enhanced diabetes knowledge, treatment satisfaction, and reduced inaccurate cultural beliefs, demonstrating that culturally tailored education can lead to better adherence to diabetes care standards and improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved care for diabetes in underserved populations. Philis-Tsimikas, A., Walker, C.[2021]

In the REWIND trial, dulaglutide effectively reduced major adverse cardiovascular events (MACE) in both older patients (≥65 years) and younger patients (<65 years), showing similar incidence rates of MACE (11% vs 13%).

The safety profile of dulaglutide was comparable across age groups, with similar rates of serious adverse events, including all-cause mortality and severe hypoglycemia, indicating that dulaglutide is a safe treatment option for both older and younger patients with type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Dulaglutide in Older Patients: A post hoc Analysis of the REWIND trial. Riddle, MC., Gerstein, HC., Xavier, D., et al.[2021]

In a pilot study involving 18 outpatients with type 2 diabetes, using the 'Calomeal' app for 3 months led to significant reductions in hemoglobin A1c (HbA1c) from 7.9% to 7.6% and body mass index (BMI) from 25.17 kg/m2 to 24.54 kg/m2, indicating improved glycemic control and weight management.

The improvements in HbA1c and BMI were associated with decreased carbohydrate intake as estimated by the app, suggesting that visualizing nutritional intake can enhance self-management in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Intervention With a Mobile Application Visualizing the Macronutrient Content for Type 2 Diabetes at a Japanese Center. Tsunemi, A., Sato, J., Sugimoto, S., et al.[2022]

The U.S.-Mexico Border Diabetes Prevention and Control Project is a collaborative effort involving over 100 organizations aimed at addressing the high prevalence of type 2 diabetes in the border region, which is a significant public health issue.

The project utilized a participatory approach, engaging diverse stakeholders to develop effective strategies for diabetes prevention and control, and it provides valuable lessons for future binational health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A historical overview of the United States-Mexico Border Diabetes Prevention and Control Project. Diaz-Kenney, RV., Ruiz-Holguín, R., de Cosío, FG., et al.[2019]

The #WeAreNotWaiting movement has led to the development of do-it-yourself artificial pancreas systems (DIYAPS) by motivated individuals in the diabetes community, which integrate continuous glucose monitoring and insulin pumps to improve glycemic control and quality of life for people with type 1 diabetes.

While DIYAPS show promising improvements in diabetes management based on anecdotal evidence and observational studies, their unregulated nature raises safety concerns, and there are significant barriers to acceptance among healthcare professionals and regulatory bodies due to ethical, legal, and funding issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Do-It-Yourself Artificial Pancreas: A Comprehensive Review. Kesavadev, J., Srinivasan, S., Saboo, B., et al.[2021]

A study analyzing 3,109 serious adverse drug reactions reported to the French pharmacovigilance system found that 83% of pancreatitis cases were associated with incretin-based drugs, indicating a significant risk for patients using these medications.

The analysis revealed a strong association between incretin-based drugs and pancreatitis, with adjusted reporting odds ratios showing a heightened risk for all GLP-1 analogs and DPP-4 inhibitors, suggesting careful monitoring is needed for patients on these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pancreatitis associated with the use of GLP-1 analogs and DPP-4 inhibitors: a case/non-case study from the French Pharmacovigilance Database. Faillie, JL., Babai, S., Crépin, S., et al.[2014]

A total of 7076 individual case safety reports (ICSRs) were analyzed, revealing that 63.6% came from the Middle East, with most reports being nonserious (91.5%) and primarily reported by consumers (70.7%).

Patients in the Middle East were younger (average age 34.2 years) and often used insulin for gestational diabetes, while those in Africa were older (average age 48.1 years) and more likely to have type 2 diabetes, indicating significant regional differences in insulin use and associated adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual Case Safety Reports Analysis for Patients with Diabetes Mellitus on Insulin in Africa and the Middle East. Mlotshwa, CRN., Burger, JR., Vorster, M., et al.[2022]

The Project Dulce model, both with and without wireless technology, significantly improved glycemic control in patients with poorly controlled type 2 diabetes, with reductions in HbA1c of -3.0% for the technology-enhanced group and -2.6% for the standard group, compared to only -1.3% in the control group.

Both Project Dulce groups also showed significant improvements in diabetes knowledge compared to the control group, indicating that this model effectively enhances both clinical outcomes and patient education in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dulce Wireless Tijuana: A Randomized Control Trial Evaluating the Impact of Project Dulce and Short-Term Mobile Technology on Glycemic Control in a Family Medicine Clinic in Northern Mexico. Anzaldo-Campos, MC., Contreras, S., Vargas-Ojeda, A., et al.[2023]

A computer-assisted self-management intervention for type 2 diabetes patients (n=335) led to significant reductions in dietary fat intake and weight compared to usual care at the 2-month follow-up.

The intervention was feasible and well-implemented, showing promise for improving lifestyle behaviors in diabetes management, although changes in HbA1c and lipids did not reach statistical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a brief computer-assisted diabetes self-management intervention on dietary, biological and quality-of-life outcomes. Glasgow, RE., Nutting, PA., Toobert, DJ., et al.[2017]

The study highlights significant gaps in global health systems, particularly in providing adequate care for diabetic patients, emphasizing the need for innovative strategies and technologies.

The proposed hIPAPD model aims to enhance self-care for diabetic patients in impoverished areas of Panama, demonstrating the potential of ICTs to improve health outcomes in regions with limited resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technologies to better serve the millions of diabetic patients: a holistic, interactive and persuasive ICT model to facilitate self care, in extremely poor rural zones of Central America. Vargas-Lombardo, M., Jipsion, A., Vejarano, R., et al.[2021]

A study involving 414 low-income Hispanic adults with poorly managed type 2 diabetes is evaluating the effectiveness of three different mobile health interventions over 12 months, including personalized text messaging and telephonic support, to improve diabetes management and clinical outcomes.

The trial aims to determine how these mobile technology approaches can enhance patient-provider communication, medication adherence, and overall diabetes control, potentially reducing health disparities in the Hispanic population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes. Philis-Tsimikas, A., Fortmann, AL., Godino, JG., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05580536

Project Dulce for Arab Americans With Type 2 Diabetes The main aim of the study is to examine the effectiveness of a more culturally and linguistically appropriate diabetes education program in improving diabetes ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05580536/project-dulce-for-arab-americans-with-type-2-diabetes

Project Dulce for Arab Americans With Type 2 Diabetes The main aim of the study is to examine the effectiveness of a more culturally and linguistically appropriate diabetes education program in ...

3. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/565-P/156652/565-P-Baseline-Findings-from-the-Dulce-Digital-2-0

565-P: Baseline Findings from the Dulce Digital 2.0 Trial ... An in-progress 3-way RCT that will compare the effectiveness of the Dulce Digital text messaging program and live in-person and virtual delivery.

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

Dulce Digital: An mHealth SMS-Based Intervention Improves ... A simple, low-cost text messaging program was found to be highly acceptable in this sample of high-risk, Hispanic individuals with type 2 diabetes.

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

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

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

Outcomes of the Dulce Digital-COVID Aware (DD-CA) ... DD-CA offered an alternative digital approach to diabetes and COVID education and support for a high-risk Hispanic population and achieved trends toward ...