AYUDA Program for Type 2 Diabetes

(AYUDA Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Kaiser Permanente

Disqualifiers: Pregnancy, Type 1 diabetes

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new text message program called AYUDA, designed to help Latinx adults manage type 2 diabetes. The goal is to determine if these text messages ease diabetes care while participants continue regular treatment. The trial seeks Latinx adults diagnosed with type 2 diabetes in the past six months who are caregivers to a child under 18. Participants will receive educational texts twice a week to support their diabetes management. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for managing diabetes.

Do I need to stop my current medications for the trial?

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 the AYUDA Program is safe for Latinx adults with type 2 diabetes?

Research has shown that lifestyle and peer support programs like AYUDA are generally safe and manageable. These programs have proven effective in managing long-term illnesses like diabetes, helping to improve blood sugar levels and overall health without major risks. Participants typically receive guidance and support through text messages, a low-risk method for diabetes management.

The AYUDA Program specifically uses text messages to provide education and resources for diabetes care. This non-invasive approach avoids medical procedures or medications that might cause side effects. Since the program emphasizes support and education rather than direct medical treatment, negative side effects are unlikely.

Overall, the AYUDA Program is a safe choice for those seeking additional support in managing their diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AYUDA Program is unique because it uses text messages to deliver diabetes education and self-management resources directly to participants' phones. Unlike standard treatments for Type 2 Diabetes, which often rely on medication, diet, and lifestyle changes, this program adds an educational component that is accessible and convenient. Researchers are excited because this approach could empower patients to manage their condition more effectively by providing regular, easily digestible information and support, potentially improving outcomes and adherence to care.

What evidence suggests that the AYUDA Program is effective for type 2 diabetes?

Research has shown that diabetes self-management education, such as the AYUDA Program, can significantly aid people with type 2 diabetes in making positive lifestyle changes and improving self-care. In this trial, participants in the AYUDA Program arm will receive text messages twice a week with education and resources related to diabetes care and self-management, alongside their usual diabetes care. Studies have found that these programs can lead to early improvements in blood sugar control, enhancing overall health over time. Additionally, peer support in these programs can help manage blood sugar and blood pressure more effectively. For instance, a similar program in Texas helped participants lower their A1c levels (a measure of blood sugar control) for over a year. This evidence suggests that the AYUDA Program could effectively assist participants in managing their diabetes. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for younger Latinx adults who have recently been diagnosed with type 2 diabetes and are caregivers to a child under 18. They must be within the Kaiser Permanente Northern California system.

Inclusion Criteria

Identifies as Latino/a/x

Can receive text messages

I am between 18 and 45 years old and was recently diagnosed with type 2 diabetes.

Exclusion Criteria

Pregnant women

I have Type 1 Diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AYUDA program, a 12-week culturally tailored text message program for diabetes care and self-management

12 weeks

Text messages twice a week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including HbA1c changes and healthcare contact

6 months

What Are the Treatments Tested in This Trial?

Interventions

• AYUDA Program

Trial Overview The AYUDA Program, a culturally tailored text message program lasting 12 weeks, is being tested for its feasibility, acceptability, and effectiveness in managing type 2 diabetes among eligible participants.

How Is the Trial Designed?

Group I: AYUDA Program Experimental Treatment 1 Intervention

Participants enrolled in the AYUDA program will receive text messages twice a week containing education and resources related to diabetes care and self-management, in addition to their usual diabetes care.

Group II: Usual Care Active Control 1 Intervention

No intervention will be employed. This arm will continue to receive their usual diabetes care.

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials

563

Recruited

27,400,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07019649?lastUpdPost=2020-01-10_

Randomized Pilot Trial of AYUDA Program for Younger ... The study will evaluate how well AYUDA helps participants reach important early blood sugar control goals, which can lead to better health over time and reduce ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8129774/

Effectiveness of diabetes self-management education (DSME ... Based on 15 articles, diabetes self-management education intervention provides significant effectiveness to lifestyle changes and the self-care of T2DM patients ...

3. link.springer.com link.springer.com/article/10.1007/s12170-024-00737-6

Recent Findings on the Effectiveness of Peer Support for ... The findings suggest that peer support can be beneficial to glycemic control and blood pressure in T2DM patients.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31247039/

Effectiveness of a Self-Management Support Program for ... Group-based self-management support results in favorable short-term behavioral changes and more persistent alterations in (perceived) empowerment.

5. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1543298/full

Comparative effectiveness of diabetes self-management ... A DSMES program in Texas reported statistically significant reductions in A1c levels at 3 months that were sustained at 6-, 9- and 12-month follow-up ...

6. diabetesjournals.org diabetesjournals.org/care/article/48/7/1101/158195/The-Diabetes-Prevention-Program-and-Its-Outcomes

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ... After mean 2.8 years, ILS reduced diabetes risk by 58% and metformin by 31%, leading to study termination ahead of schedule due to demonstrated ...

7. diabetes.org diabetes.org/newsroom/new-data-from-diabetes-prevention-program-outcomes-study-shows-persistent-reduction-of-t2d-development-over-22-year-average-follow-up

New Data from Diabetes Prevention Program Outcomes ... The DPP demonstrated lifestyle intervention, aimed at achieving weight loss, and metformin treatment reduced the risk of T2D development by 58% and 31%, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10885823/

Peer Support for Type 2 Diabetes Management in Low In recent years, peer support programs have been widely used to improve chronic disease management, alcohol and substance use as well as ...