Diabetes Prevention Program for Prediabetes

(BRIDGE Trial)

Overseen By Shneha Pradhan

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, End-stage renal disease, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best way to help older adults with prediabetes reduce their risk of developing diabetes. It compares two approaches: a traditional in-person program (Diabetes Prevention Program, or DPP) and a telehealth version (Diabetes Prevention Program Tailored for Older Adults and delivered via Telehealth, or DPP-TOAT), both designed for individuals aged 65 and up. The goal is to determine which method is more effective and convenient for participants. Suitable candidates have been diagnosed with prediabetes, have a BMI over 30, and can travel to NYU Langone for evaluations. As an unphased trial, this study offers participants the chance to contribute to innovative research that could shape future diabetes prevention strategies for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking FDA-approved weight loss medications.

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

Research has shown that the Diabetes Prevention Program (DPP) is safe for individuals with prediabetes. Studies have found that its recommended lifestyle changes, such as healthier eating and increased exercise, can reduce the risk of developing type 2 diabetes by up to 58%. Many participants have found it helpful without experiencing major side effects.

For the version designed for older adults and offered through telehealth (DPP-TOAT), less information is available. However, telehealth is becoming more common and accepted, particularly among older adults. It allows participation from home, offering convenience and comparable effectiveness.

Overall, both program versions emphasize lifestyle changes, which are generally safe and well-tolerated. No reports of serious side effects have been linked to these programs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer new ways to tackle prediabetes. Unlike traditional in-person programs that require you to attend sessions physically, the DPP-TOAT arm is tailored for older adults and delivered via telehealth, making it much more accessible for those who may have mobility issues or live far from treatment centers. This flexibility means more people can participate and benefit from the program without the usual travel hassles. Additionally, both the in-person DPP and the telehealth DPP-TOAT focus on lifestyle changes that empower participants to take active roles in their health, potentially preventing the progression to type 2 diabetes.

What evidence suggests that this trial's treatments could be effective for prediabetes?

Research has shown that the Diabetes Prevention Program (DPP), which participants in this trial may receive in person, can significantly lower the risk of developing type 2 diabetes. Studies have found that attending the in-person DPP can reduce this risk by up to 58% over three years for people with prediabetes. Furthermore, a long-term follow-up study revealed that participants were still about one-third less likely to develop diabetes even after ten years.

Another arm of this trial will study the telehealth version, called DPP-TOAT, tailored for older adults. Early results suggest it is a practical and acceptable way to offer the program to older adults, although more data is needed to compare it directly with the in-person version. Both methods focus on improving diet and increasing physical activity to achieve similar benefits. ^{1 2 3 5 6}

Who Is on the Research Team?

Jeannette Beasley, MD

Principal Investigator

NYU Langone Health

Joshua Chodosh, MD, MHS

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for English or Spanish-speaking men and women aged 65 and older with prediabetes, under NYU Langone Health's care. Participants must have a BMI of 30 or more, be able to travel for in-person evaluations, have access to a phone, and not have taken part in the Diabetes Prevention Program before.

Inclusion Criteria

I have been diagnosed with pre-diabetes based on recent tests.

Under the care of a Primary care provider (PCP) in the NYU Langone Health system

Informed consent

Exclusion Criteria

I cannot communicate well due to severe hearing loss or speech issues.

I have been diagnosed with active psychosis or cognitive issues.

I have diabetes or my kidneys are failing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the in-person DPP or the DPP-TOAT program for 12 months

12 months

Baseline visit, 6 months visit, 12 month visit

Follow-up

Participants are monitored for changes in weight and HbA1c levels after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• DPP
• DPP-TOAT

Trial Overview The study compares two versions of the Diabetes Prevention Program (DPP): one delivered in person and another tailored for older adults via telehealth. It aims to see which method is more effective at preventing diabetes among seniors.

How Is the Trial Designed?

Group I: In-person Diabetes Prevention Program (DPP) Active Control 1 Intervention

Participants randomized to the in-person DPP intervention for 12 months

Group II: DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) Active Control 1 Intervention

Participants randomized to the DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) intervention for 12 months.

DPP is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Diabetes Prevention Program for:

• Prediabetes prevention
• Type 2 diabetes prevention

Approved in European Union as National Diabetes Prevention Program for:

• Prediabetes prevention
• Type 2 diabetes prevention

Approved in Canada as CDC Diabetes Prevention Program for:

• Prediabetes prevention
• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The Diabetes Prevention Program (DPP) is a large clinical trial involving 3,234 participants aimed at evaluating interventions to prevent type 2 diabetes in individuals at high risk, with a diverse demographic including various ethnic backgrounds and age groups.

The study will assess the effectiveness of three treatment approaches: intensive lifestyle modification, standard care with metformin, and standard care with placebo, to determine their impact on delaying or preventing diabetes development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group. [2022]

A mobile-delivered version of the CDC's diabetes prevention program (DPP) led to significant weight loss in adults with prediabetes, with participants losing an average of 2.64 kg at 6 months compared to the control group, which showed no meaningful weight change.

While the mobile DPP did not significantly lower hemoglobin A1c (HbA1c) levels compared to usual care, it demonstrated a reduction in HbA1c levels over a year, indicating potential long-term benefits in diabetes risk reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. Toro-Ramos, T., Michaelides, A., Anton, M., et al.[2022]

The Diabetes Prevention Program (DPP) effectively identified high-risk adults for type 2 diabetes, with 27% of participants showing impaired glucose tolerance and 13% having previously undiagnosed diabetes based on oral glucose tolerance tests (OGTT).

Fasting capillary glucose levels, along with age and BMI, significantly improved the screening process for high-risk individuals across various ethnic groups, suggesting it can enhance the efficiency of diabetes prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to identify adults at high risk for type 2 diabetes: the Diabetes Prevention Program. [2021]

The Veterans Affairs Diabetes Prevention Program (VA-DPP) showed higher fidelity in delivery compared to the usual MOVE! program, indicating it may be more effectively implemented in clinical settings.

Participant satisfaction was generally higher in the VA-DPP, suggesting that this program not only has better implementation but also resonates more positively with participants, which is crucial for long-term success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation findings from a hybrid III implementation-effectiveness trial of the Diabetes Prevention Program (DPP) in the Veterans Health Administration (VHA). Damschroder, LJ., Reardon, CM., AuYoung, M., et al.[2022]

The Diabetes Prevention Program (DPP) can reduce the incidence of diabetes by 58% over three years for individuals with prediabetes, yet most patients are unaware of their condition.

With Medicare coverage starting in 2018, the DPP has become more accessible for patients over 65, highlighting the need for healthcare providers to implement screening and referral processes for prediabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. Jasik, CB., Joy, E., Brunisholz, KD., et al.[2019]

A telehealth-adapted Diabetes Prevention Program (DPP) for older adults showed high feasibility, with a retention rate of 75% and an average attendance of 80% across six sessions, indicating strong participant engagement.

Participants experienced a significant mean weight loss of 2.9% (2.7 kg), suggesting that the program was effective in promoting healthier lifestyles among older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BRInging the Diabetes prevention program to GEriatric populations (BRIDGE): a feasibility study. Beasley, JM., Kirshner, L., Wylie-Rosett, J., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/_7HLF9GTGkeID-m5TNDN4Q/project-details/10992118

BRinging the Diabetes Prevention Program ... - NIH RePORTER The proposed study will compare a DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) to an in person DPP tailored for older ...

2. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/1965/bringing-dpp-geriatric-populations/

Bringing the DPP to Geriatric Populations | NYU Langone Health This will be the first study to compare the effectiveness and implementation of two strategies (telehealth versus in-person) to deliver a tailored DPP for the ...

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1144156/full

Study protocol: BRInging the Diabetes prevention program ... In the original Diabetes Prevention Program (DPP) study, the diet and physical activity intervention conferred a 71% reduction in risk of type 2 ...

4. researchprotocols.org researchprotocols.org/2023/1/e50183

Telehealth Diabetes Prevention Program for Adults With ... Results: At baseline, of the 26,151 patients across 3 ambulatory clinic specialties, 1010 (3.9%) had prediabetes and were eligible for the ...

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-4-2022-8a0e0

Diabetes Prevention Program for Prediabetes (BRIDGE Trial) The Diabetes Prevention Program (DPP) is shown to reduce the risk of developing type 2 diabetes by 58% over three years for people with prediabetes, according ...

6. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561326X2300375X

Adapting the Diabetes Prevention Program for Older Adults A certified lifestyle coach delivered 2 sessions of the adapted content via videoconference to 189 older adults. Results. The first session had a 34.9% (38 ...