Diabetes Prevention Program for Prediabetes

(BRIDGE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Joshua Chodosh, MD, MHS

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NYU Langone Health

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, End-stage renal disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Over 24 million Americans are over 65 years and have prediabetes. Prediabetes can be addressed using a public health approach: among the 20% of participants in the Diabetes Prevention Program (DPP) who were ages 60 and over, the diet and physical activity intervention conferred a 71% risk reduction of diabetes after an average follow-up of 3 years. The population of older adults is projected to more than double from 52.5 million in 2019 to \~100 million by 2060, and if projections hold, about half (48.3%) will have prediabetes. The proposed hybrid effectiveness implementation type 1 design will compare a DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) to an in person DPP tailored for older adults (DPP arm) using a randomized, controlled trial design (n=230). The preliminary data suggests DPP-TOAT is a feasible and acceptable way to deliver the DPP to older adults, and 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 unique needs of the growing population of 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.

What data supports the effectiveness of the Diabetes Prevention Program (DPP) treatment for prediabetes?

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 to research supported by the American Medical Association and the Centers for Disease Control and Prevention. ^{1 2 3 4 5}

Is the Diabetes Prevention Program safe for humans?

The Diabetes Prevention Program (DPP) has been evaluated in multiple studies and is generally considered safe for humans, as it focuses on lifestyle changes to prevent diabetes. ^{1 2 3 5 6}

What makes the Diabetes Prevention Program (DPP) treatment unique for prediabetes?

The Diabetes Prevention Program (DPP) is unique because it is a lifestyle intervention that can be delivered via telehealth, making it accessible to more people, including older adults. It focuses on lifestyle changes rather than medication, and has been shown to significantly reduce the risk of developing type 2 diabetes. ^{1 2 3 4 5}

Research Team

Jeannette Beasley, MD

Principal Investigator

NYU Langone Health

Joshua Chodosh, MD, MHS

Principal Investigator

NYU Langone Health

Eligibility Criteria

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.

I speak English or Spanish.

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

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.

Trial Timeline

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

Treatment Details

Interventions

• DPP (Behavioural Intervention)
• DPP-TOAT (Behavioural Intervention)

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.

Participant Groups

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 Canada for the following indications:

Approved in Canada as CDC Diabetes Prevention Program for:

• Prediabetes prevention
• Type 2 diabetes prevention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

NYU Langone Health New York, NY

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1431

Patients Recruited

838,000+

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

Collaborator

Trials

2513

Patients Recruited

4,366,000+

Findings from Research

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

References

1. England 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). [2022]

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

Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. [2019]

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

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

4. England pubmed.ncbi.nlm.nih.gov

BRInging the Diabetes prevention program to GEriatric populations (BRIDGE): a feasibility study. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. [2022]

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

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