Diabetes BOOST Program for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Geraldine Puerto, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Daniel Amante

Disqualifiers: Cognitive impairment, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a program called Diabetes BOOST, designed to help Latinx individuals with type 2 diabetes manage their condition more effectively. The goal is to ensure the program is culturally appropriate and engaging by using tools like personalized messages and video calls. Participants will either try this new approach or continue with their usual care, which includes standard diabetes education. The trial seeks Hispanic or Latinx individuals who prefer speaking Spanish and have been diagnosed with type 2 diabetes. As an unphased trial, participants can contribute to research that may lead to more personalized and culturally relevant diabetes care.

Do I have to stop taking 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments like Diabetes BOOST have been well-studied for preventing type 2 diabetes. For instance, studies on intensive lifestyle programs have found they can lower the risk of developing diabetes by 58%. These programs often involve setting and achieving personal health goals, similar to the Diabetes BOOST treatment.

Although specific safety data for Diabetes BOOST is not yet available, the method it uses is well-known and generally considered safe. Lifestyle programs usually focus on diet, exercise, and self-care education, which most people handle well. No major reports of negative effects have emerged from these types of programs, suggesting that participants usually do well with them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Diabetes BOOST Program is unique because it leverages personalized digital support to enhance self-management for individuals with Type 2 Diabetes. Unlike standard care, which often relies on generalized education, this program uses secure messages, text messages, and video calls to deliver tailored self-care education and goal-setting encouragement directly to patients. Researchers are excited about this program because it empowers patients to actively participate in their care through personalized communication and telehealth tools, potentially leading to better management of their condition and improved health outcomes.

What evidence suggests that the Diabetes BOOST program could be effective for Type 2 Diabetes?

Research has shown that lifestyle changes, like those in the Diabetes BOOST program, can greatly lower the risk of developing type 2 diabetes. In an earlier study, participants who followed a similar program reduced their risk by 58% through diet and exercise changes, proving that structured self-management works. In this trial, participants in the Diabetes BOOST arm will engage in a comprehensive self-care education program, while the Usual Care arm will follow standard diabetes self-management training. Programs focused on diabetes care have improved overall health, especially in diverse communities. These findings suggest that Diabetes BOOST could effectively help manage type 2 diabetes. ^{1 2 4 6 7}

Who Is on the Research Team?

Daniel Amante, PhD, MPH

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latinx adults over 18 with type 2 diabetes who prefer to speak Spanish and have completed a diabetes self-management training in the past year. It's not suitable for those with cognitive impairments, pregnant women, or current prisoners.

Inclusion Criteria

I am older than 18 years.

I have been diagnosed with type 2 diabetes.

I completed a diabetes self-management training last year.

Exclusion Criteria

Pregnant women

Current prisoner

I have difficulty with memory or thinking clearly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants complete a baseline survey, receive DSMT referral, and engage in self-care education via secure messages, text messages, and video calls. They also complete a telehealth training video call and set personalized goals.

3 months

Multiple virtual interactions

Follow-up

Participants complete a 3-month follow-up survey and qualitative interview to assess diabetes treatment satisfaction and self-efficacy.

3 months

Extended Follow-up

Participants' HbA1c values are monitored to determine the impact of the intervention, with data obtained through EHR chart review.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes BOOST
• Usual Care

Trial Overview

The study is testing 'DM-BOOST para Latinx,' an adapted version of the DM-BOOST program designed to help Latinx patients manage their diabetes using behavioral economics and technology. The effectiveness will be assessed through community-based participatory research.

How Is the Trial Designed?

Group I: Intervention - Diabetes BOOST Experimental Treatment 1 Intervention

Intervention group participants will complete a baseline survey, receive a referral to DSMT from the research team, a mailed welcome letter and self-care education sent via a series of personalized patient portal secure messages, text messages, and video call. They will be sent text messages with information about one of the American Association of Diabetes Educators 7 self-care behaviors and will receive encouragement to author their own self-management behavioral goals. Participants will also complete a telehealth training video call with research staff to review the functionality of their patient portal and refine diabetes-related goals. The participant will then be encouraged to send a patient portal message to their DSMT CDCES that includes their personalized goals prior to their scheduled DSMT session. They will then complete a 3-month follow-up survey and qualitative interview.

Group II: Usual Care Active Control 1 Intervention

Comparison Group participants will complete a baseline survey, receive a DSMT referral request from research team to their primary care provider and a mailed welcome letter. The mailed letter will welcome the participant to the study and contain general information about diabetes self-care behaviors and goal setting. They will complete a DSMT session. They will then complete a 3-month follow-up survey and qualitative interview.

Who Is Running the Clinical Trial?

Daniel Amante

Lead Sponsor

Trials

2

Recruited

140+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1.

niddk.nih.gov

niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp

Diabetes Prevention Program (DPP) - NIDDK

After about 3 years, the DPP showed that participants in the DPP Lifestyle Change Program lowered their chances of developing type 2 diabetes by 58 percent ...

2.

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 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12178622/

The Diabetes Prevention Program and Its Outcomes Study

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 efficacy of both ...

4.

diabetes.org

diabetes.org/about-us/research/recent-advances

Recent Advances

Results from this study demonstrate the value of diabetes self-management programs and their potential to broadly improve health outcomes in socioeconomically ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2773065425000896

Real-World Interventions for Type 2 Diabetes Prevention ...

In 2002, the Diabetes Prevention Program (DPP) clinical trial demonstrated that a structured lifestyle intervention was effective in delaying or preventing the ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT00038727

Diabetes Prevention Program Outcomes Study

The Diabetes Prevention Program (DPP) was a multi-center trial examining the ability of an intensive lifestyle or metformin to prevent or delay the development ...

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%, ...