Diabetes Prevention Program + INSPIRA for Prediabetes

(INSPIRA Trial)

Overseen By Shelley Stoll, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Schizophrenia, Drug abuse, Pregnancy, others

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

Compensation: Varies

Number of Visits: 16

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help people with prediabetes adopt healthier habits to prevent diabetes. It compares the standard Diabetes Prevention Program (DPP) with an enhanced version called INSPIRA, which includes peer support and healthy food vouchers. The goal is to determine if these additional supports improve adherence to the program. Individuals who speak English or Spanish, have a BMI over 24.9, and recent A1c levels between 5.7% and 6.4% may be suitable candidates. Participants will join one of the two groups and participate for about six months. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in diabetes prevention.

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

The trial information does not specify whether you need to stop taking your current medications. It is 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 shows that the Diabetes Prevention Program (DPP) effectively reduces the risk of developing type 2 diabetes. Studies have found that participants in this program cut their chances of getting diabetes by about half over several years, demonstrating the program's long-term effectiveness and safety.

The INSPIRA part of the study aims to increase participation in the DPP by offering peer support and food vouchers. A small initial study of INSPIRA showed it helped people improve their health management. Since INSPIRA adds extra support to the DPP, it is also expected to be safe.

In summary, both the DPP and the additional support from INSPIRA have been shown to be safe in past research. Participants typically do well in these programs, with no serious safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Diabetes Prevention Program (DPP) combined with the INSPIRA intervention because it offers a fresh approach to tackling prediabetes. Unlike standard care options like lifestyle changes and medications, this combined approach not only emphasizes established lifestyle modifications but also introduces additional interventions that could enhance outcomes. The unique aspect of this combination is its potential to address multiple facets of prediabetes management, offering a more comprehensive strategy that could improve prevention efforts and reduce the progression to type 2 diabetes.

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

Studies have shown that the Diabetes Prevention Program (DPP) can reduce the risk of developing type 2 diabetes by 58% over three years for people with prediabetes. This program emphasizes lifestyle changes, such as healthy eating and exercise. In this trial, one group will receive the DPP as usual care, while another group will receive the DPP plus the INSPIRA intervention. The INSPIRA addition aims to enhance these benefits by pairing participants with a support partner and providing vouchers for healthy food. The INSPIRA study examines how these extra supports can make the program more effective and easier to follow. Early findings suggest that these enhancements could improve participation and outcomes for those at risk of diabetes. ^{1 2 6 7 8}

Who Is on the Research Team?

Mary Ellen M Heisler, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with prediabetes, specifically those who have a BMI over 24.9 and an A1c level between 5.7%-6.4%. Participants must be able to attend sessions in English or Spanish and commit to the local area for six months. It's not suitable for individuals with active substance abuse, schizophrenia, or those pregnant or planning pregnancy soon.

Inclusion Criteria

Your most recent A1c test taken in the last 60 days shows a result between 5.7% and 6.4%.

You weigh more than what is considered healthy for your height.

Exclusion Criteria

I cannot attend sessions, either in-person or online, for the next three weeks.

Will not be in local area in six months

Are pregnant or planning pregnancy in next 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Diabetes Prevention Program (DPP) with or without additional INSPIRA interventions for 6 months

24 weeks

16 weekly group sessions

Follow-up

Participants are monitored for changes in weight, waist circumference, and diet quality

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes Prevention Program
• INSPIRA

Trial Overview The study compares two approaches: the standard Diabetes Prevention Program (DPP) versus DPP plus INSPIRA, which includes peer support and healthy food vouchers as incentives. Participants will be randomly assigned to one of these groups for about half a year.

How Is the Trial Designed?

Group I: DPP plus the INSPIRA intervention Experimental Treatment 2 Interventions

This arm will include the DPP plus additional interventions.

Group II: Diabetes Prevention Program (DPP) (usual care) Active Control 1 Intervention

Diabetes Prevention Program is already approved in United States for the following indications:

Approved in United States as National Diabetes Prevention Program (NDPP) for:

• Prediabetes
• Type 2 diabetes prevention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Published Research Related to This Trial

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) 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]

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 Diabetes Prevention Program (DPP) is a large-scale clinical trial aimed at preventing type 2 diabetes in high-risk individuals, with 3,048 participants recruited from a pool of over 133,000 screened, highlighting its extensive reach.

The trial includes diverse participants, with 45% from ethnic minority groups and 67% being women, ensuring a representative sample for evaluating the effectiveness of lifestyle changes and metformin in diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Background and recruitment data for the U.S. Diabetes Prevention Program. Fujimoto, WY.[2018]

The Intensive Lifestyle Intervention (ILI) in the Diabetes Prevention Program (DPP) effectively helped approximately 3800 high-risk adults with prediabetes achieve weight loss through dietary and exercise modifications, demonstrating a practical approach to delaying or preventing type 2 diabetes.

The DPP and its follow-up, the DPP Outcomes Study (DPPOS), highlight the importance of lifestyle changes in managing prediabetes, particularly in a diverse population, suggesting that these interventions can be tailored to various ethnic backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Diabetes Through the Lifestyle Intervention: Lessons Learned from the Diabetes Prevention Program and Outcomes Study and its Translation to Practice. Hoskin, MA., Bray, GA., Hattaway, K., et al.[2019]

In a modified Diabetes Prevention Program (DPP) for patients with non-alcoholic fatty liver disease (NAFLD), 79% of participants completed the program, leading to significant weight loss and improvements in liver health indicators over 12 months.

Key improvements included reduced hepatic steatosis and liver enzymes, indicating enhanced liver function, although there was a noted increase in low-density lipoprotein levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modification of the diabetes prevention program for the treatment of nonalcoholic fatty liver disease: A pilot study. Hershman, M., Torbjornsen, K., Pang, D., et al.[2023]

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442500165X

INSPIRing Action to Prevent Diabetes (INSPIRA) The INSPIRA Study is thus assessing the feasibility, acceptability, and preliminary effectiveness of a program that supplements a community health worker (CHW)- ...

3. withpower.com withpower.com/trial/phase-prediabetic-state-8-2023-2394b

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

4. cdc.gov cdc.gov/diabetes-prevention/index.html

National Diabetes Prevention Program The National Diabetes Prevention Program is building a nationwide network for its lifestyle change program, which is proven to cut type 2 diabetes risk in half.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00004992

Study Details | NCT00004992 | Diabetes Prevention Program Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes.

6. cdc.gov cdc.gov/diabetes-prevention/programs/what-is-the-national-dpp.html

What Is the National DPP? | National Diabetes Prevention ... A 10-year follow-up study, The Diabetes Prevention Program Outcomes Study, showed that participants were still one-third less likely to develop ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S155171442500165X

INSPIRing action to prevent diabetes (INSPIRA) A pilot intervention combining peer support and food voucher incentives to increase engagement in a community health worker-led diabetes prevention program.

8. diabetes.org diabetes.org/about-diabetes/diabetes-prevention/dpp

Learn About the National Diabetes Prevention Program The National Diabetes Prevention Program (National DPP) is based on a curriculum shown to prevent or delay the onset of type 2 diabetes in adults that are ...