Cash Incentives for Type 2 Diabetes

(DMCT Trial)

Not currently recruiting at 1 trial location

Overseen By Jennifer A Campbell, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Dementia, Alcohol abuse, Psychosis, others

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

Compensation: Varies

Number of Visits: 12

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how cash incentives might help individuals with poorly managed type 2 diabetes improve their health and well-being. One group will receive monthly cash payments for participating in biweekly online sessions about managing diabetes and stress, while another group will receive cash without conditions. The researchers aim to determine if these strategies improve blood sugar control, self-care habits, and mental health. African American adults with type 2 diabetes living in an inner city and struggling with high blood sugar may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies for managing diabetes and enhancing overall health.

Do I need to stop my current medications for this 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?

Past studies have generally shown that diabetes-focused education programs are well-received by participants. For example, research on culturally tailored diabetes education found that people could participate without major issues. These programs often aim to improve diabetes care and reduce stress, offering benefits without causing harm.

Another study using similar diabetes education methods reported that participants did not experience significant negative side effects. This suggests that the approach used in the DM-CCT intervention, which includes diabetes education and stress management, is likely safe.

While direct data on the safety of the DM-CCT intervention is lacking, similar educational programs have proven safe for participants. This is encouraging for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for Type 2 Diabetes because they explore the impact of cash incentives on disease management. The Diabetes-Tailored Conditional Cash Transfer (DM-CCT) is unique because it ties financial rewards to active participation in diabetes education and stress management sessions, potentially motivating lifestyle changes and better health outcomes. On the other hand, the Unconditional Cash Transfer (UCT) provides financial support without conditions, allowing researchers to see if monetary assistance alone can improve diabetes management. These approaches are different from standard treatments, which typically focus on medication and diet changes, by incorporating financial motivation as a tool for improving patient engagement and self-care.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

This trial will compare two approaches to cash incentives for managing Type 2 Diabetes. Participants in one arm will receive Diabetes-Tailored Conditional Cash Transfers (DM-CCT), where cash rewards depend on attending diabetes education and stress management sessions. Studies have shown that teaching people about diabetes can significantly help them control blood sugar and improve quality of life. Research suggests that adding cash rewards to education might enhance these benefits.

In the other arm, participants will receive Unconditional Cash Transfers (UCT), where cash rewards come without conditions, though educational materials will be sent by mail. Similar programs have helped people improve self-care and mental well-being. Other studies have shown improvements in managing blood sugar levels. While the exact effect of cash rewards is still under study, early signs suggest they could effectively encourage participation in health programs. ^{1 6 7 8 9}

Who Is on the Research Team?

Jennifer A Campbell, PhD

Principal Investigator

State University at Buffalo

Are You a Good Fit for This Trial?

This trial is for African Americans living in inner city areas, aged 18 or older, with poorly controlled Type 2 Diabetes (HbA1c ≥8%), and earning around the federal poverty level. They must speak English and not be involved in other diabetes trials, have a life expectancy of at least six months, and no drug abuse issues or severe mental health conditions.

Inclusion Criteria

Income greater or equal to 133% of federal poverty level or Medicaid eligible

I have type 2 diabetes with an HbA1c level of 8% or higher.

Self-report as African American

Exclusion Criteria

Participation in other diabetes clinical trials

Alcohol or drug abuse/dependency

Life expectancy <6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cash transfers conditional on attending biweekly virtual diabetes education/skills training and stress/coping sessions for 6 months

6 months

12 virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DM-CCT
• DM-UCT

Trial Overview The study compares two approaches: DM-CCT involves biweekly virtual education on diabetes management plus stress coping skills tied to cash rewards; DM-UCT provides unconditional cash without these requirements. The goal is to see which method better improves blood sugar control, self-care behaviors, quality of life, and psychological health.

How Is the Trial Designed?

Group I: Diabetes-Tailored CCTs (DM-CCT) Intervention Experimental Treatment 1 Intervention

Participants randomized to DM-CCT will receive cash transfers of $500 per month for 6 months, but the cash transfers will be conditional on attending a 60-minute diabetes education/skills training (30 minutes) and stress/coping (30 minutes) session delivered by trained nurses every 2 weeks for 6 months (12 sessions). Therefore, they will only receive cash transfer payments if they attend two sessions per month.

Group II: Unconditional Cash Transfer-UCTs Intervention Active Control 1 Intervention

Participants randomized to UCT will receive cash transfers of $500 per month for 6 months, but there will be no conditions attached. Therefore, they will receive cash transfer payments every month. However, to control for content and attention, participants will receive mailed version of the diabetes education/skills training materials every two weeks on the same schedule as the DM-CCT telephone sessions.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

A qualitative study involving 12 patients with diabetes revealed that 83% were interested in using financial incentives to enhance their self-management of the condition.

Incentives can help patients during the initial learning phase of developing healthy habits and also acknowledge their efforts during stable management phases, but careful planning is needed to prevent a decrease in intrinsic motivation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploration of attitudes toward the use of patient incentives to support diabetes self-management. Blondon, K., Klasnja, P., Coleman, K., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10759074/

Effectiveness of a culturally tailored diabetes education ... The primary outcomes are changes in haemoglobin A1c and CGM-derived metrics at 3 and 6 months. The secondary outcomes include participants' self ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK56889/

The clinical effectiveness of diabetes education models ... - NCBI Some of the included trials reported significant improvements in metabolic control and/or quality of life or other psychological outcomes; however, many others ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05559892

Conditional Cash Transfer Intervention to Improve T2DM This study will test the preliminary efficacy of diabetes-tailored CCT (DM-CCT), which will be conditional on participating in biweekly (every two weeks), ...

4. researchgate.net researchgate.net/publication/357647926_Clinical_and_patient-centered_implementation_outcomes_of_mHealth_interventions_for_type_2_diabetes_in_low-and-middle_income_countries_a_systematic_review

Clinical and patient-centered implementation outcomes of ... Clinical and patient-centered implementation outcomes of mHealth interventions for type 2 diabetes in low-and-middle income countries: a systematic review.

5. acc.org acc.org/Latest-in-Cardiology/Articles/2024/07/24/15/49/COORDINATE-Diabetes-Intervention-Improves-Evidence-Based-Care

COORDINATE-Diabetes Intervention Improves Evidence- ... A multifaceted, clinic-based intervention shown to increase the use of evidence-based medications in patients with diabetes (T2D) and atherosclerotic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11985481/

A Randomized Clinical Trial of a Culturally Tailored Diabetes ... This is an open-label randomized control trial of Latinos with uncontrolled (HbA1c > 8.0%) type 2 diabetes conducted in a Federally Qualified Health Center ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04226027

Dynamically Tailored Behavioral Interventions in Diabetes In this project, the investigators will evaluate the efficacy of a novel approach to personalizing behavioral interventions for self-management of type 2 ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421002470

Assessing the impact of medically tailored meals and ... Research has shown that among people with type 2 diabetes mellitus, reduction in hemoglobin A1c (HbA1c) prevents long term complications. Medically tailored ...

9. diabetesjournals.org diabetesjournals.org/care/article/47/8/1299/156804/The-Final-Frontier-in-Diabetes-Care-Implementing

The Final Frontier in Diabetes Care: Implementing Research ... The foundational evidence demonstrating that structured lifestyle interventions can prevent the onset of T2D emerged from five efficacy trials, ...