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?

Arab Americans (AA) face many challenges in diabetes self-management due to the limited educational resources and support available for them. The cultural and linguistic barriers between patients and health care providers lead to poor diabetes management and outcomes. This study (Project Dulce Arabic) is adapted from the Project Dulce, an American Diabetes Association (ADA)-recognized Diabetes Self-Management Education Support (DSMES) program. Project Dulce Arabic comprises both peer-led diabetes education in Arabic and a 3-month text messaging program (Dulce Digital). The main aim of the study is to examine the effectiveness of a more culturally and linguistically appropriate diabetes education program in improving diabetes knowledge, beliefs, and self-management as well as hemoglobin A1C.

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.

Is Project Dulce safe for humans?

There is no specific safety data available for Project Dulce itself, but similar treatments like GLP-1 analogs have been associated with an increased risk of pancreatitis (inflammation of the pancreas) in some studies. ^{1 2 3 4 5}

How is the Project Dulce treatment for Type 2 Diabetes different from other treatments?

Project Dulce combines a nurse-managed educational program with Dulce Digital, a text messaging service, to improve diabetes care for underserved populations, particularly Hispanics. This approach is unique because it addresses cultural barriers and healthcare access issues by using mobile technology to support health behavior changes and improve glycemic control. ^{3 6 7 8 9}

What data supports the effectiveness of the treatment Project Dulce for Type 2 Diabetes?

Research shows that Project Dulce, a diabetes education and treatment program, has improved diabetes care in underserved populations, particularly among Latinos. Additionally, the Dulce Digital program, which uses text messaging for education, has been shown to improve blood sugar control compared to usual care. ^{3 7 10 11 12}

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 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 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]

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]

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]

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]

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]

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]

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 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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Improved care for diabetes in underserved populations. [2021]

2. United States 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. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A pharmacist and health promoter team to improve medication adherence among Latinos with diabetes. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of a brief computer-assisted diabetes self-management intervention on dietary, biological and quality-of-life outcomes. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Dulce Digital-Me: protocol for a randomized controlled trial of an adaptive mHealth intervention for underserved Hispanics with diabetes. [2023]

6. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Individual Case Safety Reports Analysis for Patients with Diabetes Mellitus on Insulin in Africa and the Middle East. [2022]

7. England 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Dulaglutide in Older Patients: A post hoc Analysis of the REWIND trial. [2021]

9. Germany 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. [2014]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Lessons Learned From a Program to Reduce Diabetes Risk Among Low-Income Hispanic Women in a Community Health Clinic. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

A historical overview of the United States-Mexico Border Diabetes Prevention and Control Project. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Early Lifestyle Interventions in People with Impaired Glucose Tolerance in Northern Colombia: The DEMOJUAN Project. [2020]