Project Dulce for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Lannea Hand, MS, RDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Scripps Whittier Diabetes Institute

Disqualifiers: Pregnant, Other diabetes study

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: Unknown

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve diabetes management for Arab Americans by providing culturally relevant education and support. Participants will join a peer-led program and receive text messages designed to enhance their diabetes knowledge and self-care practices. This program, called Project Dulce + Dulce Digital, specifically targets individuals who identify as Arab, have type 2 diabetes, and face challenges in managing their condition. Participants must communicate in both English and Arabic and have access to a cell phone for the text messaging program. As an unphased trial, this study offers a unique opportunity for tailored support and education to better manage diabetes.

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 consult with the study coordinators for guidance.

What prior data suggests that this diabetes education program is safe?

Research shows that Project Dulce and Dulce Digital are generally easy for participants to handle. In previous studies, the Dulce Digital program, which uses text messages to help manage diabetes, proved very popular among people at high risk for type 2 diabetes. Participants appreciated the simple and affordable text message support, and no major problems emerged.

The Project Dulce program, designed for Arab Americans, aims to address cultural and language challenges in diabetes care. Although specific safety data for this version is unavailable, the original Project Dulce received praise from the American Diabetes Association for its success in providing diabetes education and support. This suggests it is a safe way to help people manage their diabetes better.

Overall, these programs are designed to be helpful and easy to use, with no significant negative effects reported in the studies reviewed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Project Dulce and Dulce Digital because they offer a unique approach to managing Type 2 Diabetes through education and digital support. Unlike standard treatments that focus primarily on medication and clinical interventions, this program emphasizes peer-led group education to boost self-management skills. Additionally, the use of ongoing support via text messages helps improve health knowledge and behaviors, making it a comprehensive strategy for better clinical outcomes. This combination of community support and digital communication could lead to more sustainable improvements in managing diabetes.

What evidence suggests that Project Dulce + Dulce Digital is effective for Type 2 Diabetes?

Research has shown that Project Dulce, a diabetes education program, helps people manage their diabetes more effectively. The program emphasizes increasing knowledge, changing beliefs, and improving self-care habits, all crucial for controlling type 2 diabetes. In this trial, participants will engage in Project Dulce + Dulce Digital, which includes a peer-led group diabetes self-management education and support program, along with ongoing support via text messages. Studies have found that Dulce Digital significantly lowers hemoglobin A1C levels, an important measure of blood sugar control, over 10 months compared to regular care. High-risk groups have well-received this method, demonstrating its potential to overcome challenges and improve diabetes outcomes. For Arab Americans, the program combines culturally tailored education with ongoing digital support to address specific challenges and enhance diabetes management. ^{1 3 6 7 8}

Who Is on the Research Team?

Ahmed Khattab, MD

Principal Investigator

Scripps

Are You a Good Fit for This Trial?

This trial is for Arab-Americans who can communicate in English and Arabic, have type 2 diabetes with a recent HbA1c of at least 8%, and are registered or willing to register at the community clinic. They must not have severe illnesses, certain past malignancies, liver issues, anemia, other types of diabetes, or be pregnant.

Inclusion Criteria

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

Registered in the community clinic (or willing to register)

Your blood sugar level has been consistently high in the past month.

Exclusion Criteria

You weigh less than a certain amount for your height.

Not a permanent resident in the area

I have type 1 diabetes or had diabetes during pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peer-led Education Program

Participants engage in a 5-week peer-led educational program in Arabic to enhance diabetes knowledge, beliefs, and self-management behaviors.

5 weeks

Text Messaging Support

Participants receive ongoing support via a 3-month text messaging program designed to improve diabetes management.

3 months

Follow-up

Participants are monitored for changes in diabetes knowledge, health beliefs, self-management behaviors, and clinical outcomes at 3 and 6 months.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Project Dulce + Dulce Digital

Trial Overview

Project Dulce Arabic is being tested; it's a culturally tailored education program for managing type 2 diabetes that includes peer-led sessions in Arabic and a text messaging service over three months. The goal is to improve patients' knowledge about diabetes and their self-care habits.

How Is the Trial Designed?

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

Participants 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]

The De Por Vida project successfully adapted diabetes prevention strategies from the Diabetes Prevention Program and Look AHEAD studies for Hispanic women in a low-income setting, demonstrating the potential for culturally tailored interventions to reduce diabetes risk.

This randomized clinical trial involved a 12-month program that emphasized community collaboration and cultural responsiveness, highlighting the importance of engaging both clinic staff and researchers to address barriers in implementing health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned From a Program to Reduce Diabetes Risk Among Low-Income Hispanic Women in a Community Health Clinic. Lindberg, NM., Vega-López, S., LeBlanc, ES., et al.[2021]

In the DEMOJUAN study, which involved a 24-month randomized controlled trial with participants at high risk for type 2 diabetes, early lifestyle interventions (nutritional and physical activity) did not significantly improve the chances of reverting to normal glucose metabolism compared to standard care.

The relative risks for reversion to normoglycemia were 0.88 for the nutritional intervention and 0.95 for the physical activity intervention, indicating no statistically significant benefits from these lifestyle changes in preventing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Lifestyle Interventions in People with Impaired Glucose Tolerance in Northern Colombia: The DEMOJUAN Project. Barengo, NC., Acosta, T., Arrieta, A., et al.[2020]

A team of pharmacists and health promoters effectively collaborated to manage diabetes in underserved Latino patients, leading to significant medication adjustments and improved self-care over a 6-month period.

Among the nine participants, the average hemoglobin A1C level decreased from 9.6% to 9.0%, demonstrating the potential efficacy of this team-based approach in improving blood glucose control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pharmacist and health promoter team to improve medication adherence among Latinos with diabetes. Gerber, BS., Cano, AI., Caceres, ML., et al.[2021]

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]

In a study of 9901 participants with type 2 diabetes, weekly subcutaneous dulaglutide 1.5 mg significantly reduced the total incidence of major adverse cardiovascular events (MACE) and non-cardiovascular deaths compared to placebo, showing an absolute reduction of 4.5 events per 1000 person-years.

Dulaglutide also decreased the incidence of expanded MACE (which includes additional cardiovascular issues) by 7.6 events per 1000 person-years, indicating its effectiveness in lowering the overall burden of cardiovascular events in patients at moderate cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total cardiovascular or fatal events in people with type 2 diabetes and cardiovascular risk factors treated with dulaglutide in the REWIND trail: a post hoc analysis. Dagenais, GR., Rydén, L., Leiter, LA., 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]

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 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]

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]

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]

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Project Dulce for Arab Americans With Type 2 Diabetes

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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.

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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.

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clinicaltrial.be/en/details/16586?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Dulce Digital 2.0 - Innovative Diabetes Self-Management i...

A previous randomized controlled trial of Dulce Digital demonstrated a significant reduction of HbA1c across 10 months versus usual care in ...

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This is a three-arm, parallel group, randomized trial with equal allocation ratio enrolling Hispanic adults with low income and poorly managed type 2 diabetes.

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Project Dulce for Arab-Americans With Type 2 Diabetes

Project Dulce Arabic is a pilot study addressing both the linguistic and cultural barriers faced by the AA community in diabetes self-management ...

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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 ...