iHERO Toolkit for Type 1 Diabetes

Recruiting at 3 trial locations

Overseen By Dionne Williams, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Julia Blanchette

Disqualifiers: Cognitive impairment, Non-English speakers, Others

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

Compensation: Varies

Number of Visits: 7

192 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a toolkit designed to help young adults with type 1 diabetes manage their condition more effectively. The iHERO Toolkit includes videos and online resources to reduce financial stress and improve understanding of health insurance. Researchers aim to evaluate the toolkit's effectiveness, particularly for those on Medicaid or from diverse backgrounds. Individuals who have had type 1 diabetes for at least a year and live in the U.S. might find this trial suitable. Participants will complete surveys and a home A1c test (a simple blood test to check average blood sugar levels) over a year. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on financial and health insurance support rather than medication changes.

What prior data suggests that the iHERO Toolkit is safe for young adults with type 1 diabetes?

Research shows that the iHERO Toolkit helps young adults with type 1 diabetes manage their health insurance and reduce financial stress. This toolkit includes short videos and online materials and, unlike medication, does not cause physical side effects.

Previous studies have not reported any safety concerns or negative effects from using the iHERO Toolkit. Instead, it helps young adults better manage their diabetes and understand their health insurance. Participants will use the toolkit online and fill out surveys, and it is generally well-received.

As an informational and supportive tool, it is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The iHERO Toolkit is unique because it offers a digital approach to managing Type 1 Diabetes, using micro-videos and online resources to educate and empower patients. Unlike traditional treatments that focus on medication and insulin delivery, this toolkit emphasizes patient education and self-management, helping individuals better understand and control their condition. Researchers are excited because it has the potential to enhance patient engagement and improve outcomes without adding new medications, making management more accessible and personalized.

What evidence suggests that the iHERO Toolkit is effective for young adults with type 1 diabetes?

Research has shown that the iHERO Toolkit, which participants in this trial may receive, might help young adults with Type 1 diabetes manage their health more effectively. It reduces financial concerns and aids in understanding health insurance. Early feedback suggests that this toolkit, which includes short videos and online resources, enhances diabetes management. By focusing on finances and insurance, the iHERO Toolkit aims to help users make informed health choices. This could be particularly beneficial for those on Medicaid or from diverse racial or ethnic backgrounds. ^{1 3 4 5 6}

Who Is on the Research Team?

Julia Blanchette, PhD

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

The iHERO study is for young adults with type 1 diabetes, particularly those using Medicaid and from diverse racial or ethnic backgrounds. Participants will engage in the study at four different times over a year, filling out surveys and completing an A1c test via Zoom.

Inclusion Criteria

I have been diagnosed with type 1 diabetes.

Geographical location: residing in the United States.

I have had Type 1 Diabetes for at least a year.

Exclusion Criteria

Inability to read or understand English

I am unable to answer questions because of my cognitive condition.

I have diabetes that requires insulin but is not type 1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Participants fill out online enrollment and demographic forms and complete 9 surveys. A home A1c collection is conducted with a University Hospitals team member on Zoom.

1 month

1 virtual visit

Intervention

Participants in the iHERO Resource Group receive the toolkit consisting of micro-videos and supplemental online resources.

12 months

3 virtual check-ins at 1 month, 6 months, and 12 months

Follow-up

Participants are monitored for changes in diabetes-specific quality of life, financial stress, health insurance literacy, and transition navigation readiness.

12 months

3 virtual assessments at 1 month, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• iHERO Toolkit

Trial Overview This trial tests the iHERO Toolkit Resource designed to help manage financial stress and improve health insurance literacy among young adults with type 1 diabetes. The impact on self-management of diabetes will be measured through surveys and A1c levels.

How Is the Trial Designed?

Group I: iHERO Resource Group Experimental Treatment 1 Intervention

Toolkit consisting of micro-videos and supplemental online resources.

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Julia Blanchette

Lead Sponsor

Trials

1

Recruited

190+

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

Published Research Related to This Trial

Individuals with Type 1 Diabetes Mellitus (T1DM) experience a significantly higher overall burden in terms of health status, work productivity loss, and healthcare resource use compared to those without diabetes, based on survey data from a large representative sample of EU adults.

The burden associated with T1DM increases with the number of complications, highlighting the need for treatment strategies that consider not only clinical outcomes but also the humanistic and economic impacts of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Humanistic Burden of Type 1 Diabetes Mellitus in Europe: Examining Health Outcomes and the Role of Complications. Rydén, A., Sörstadius, E., Bergenheim, K., et al.[2022]

A trial involving 308 children with type 1 diabetes found that standardized self-management kits did not improve glycemic control, as evidenced by no significant change in HbA1c levels after 6 months, with only 18% of participants achieving recommended levels.

While the kits initially reduced worry about diabetes management at 3 months, they ultimately led to increased worry and decreased treatment adherence by 6 months, suggesting that the kits may have hindered effective self-management rather than helping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardised self-management kits for children with type 1 diabetes: pragmatic randomised trial of effectiveness and cost-effectiveness. Noyes, J., Allen, D., Carter, C., et al.[2023]

The Type 1 Diabetes Exchange Quality Improvement Collaborative (T1DX-QI) has successfully expanded over 8 years to include various centers across the U.S., leading to significant improvements in type 1 diabetes care.

Key factors for the collaborative's success include data-sharing, benchmarking, and peer collaboration, with future plans to involve more centers focused on adult care and underserved communities to enhance care for all individuals with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline Quality Improvement Capacity of 33 Endocrinology Centers Participating in the T1D Exchange Quality Improvement Collaborative. Marks, BE., Mungmode, A., Neyman, A., et al.[2023]

Patients diagnosed with type 1 diabetes can expect an additional life expectancy of about 45.12 years, but they also face an estimated 17.63 years of life lost due to the condition, based on a study of 2386 cases from Taiwan's National Health Insurance Database.

Early diagnosis of type 1 diabetes leads to longer life expectancy and lower health care costs compared to late diagnosis, while males tend to have shorter life expectancy and higher expected years of life lost than females, suggesting the need for tailored health strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Life Expectancy and Lifetime Health Care Expenditures for Type 1 Diabetes: A Nationwide Longitudinal Cohort of Incident Cases Followed for 14 Years. Ou, HT., Yang, CY., Wang, JD., et al.[2017]

A 5-day structured education program for Type 1 diabetes significantly improved diabetes control, with a notable reduction in glycated hemoglobin (HbA1c) by 0.42% in 63 patients after one year, especially among those with initially high HbA1c levels.

The program also led to a significant decrease in severe hypoglycemia incidents, dropping from 10 episodes in the year prior to just 1 episode after the course, alongside improvements in quality of life measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hub-and-spoke model for a 5-day structured patient education programme for people with Type 1 diabetes. Rogers, H., Turner, E., Thompson, G., et al.[2022]

The ECHO T1D program successfully improved the diabetes knowledge and confidence of 70 primary care providers (PCPs) in managing type 1 diabetes (T1D) through 27 tele-education clinics over a 6-month period, demonstrating its effectiveness in enhancing care in underserved areas.

The program reached over 2000 patients with T1D across 23 clinics in Florida and California, showcasing its potential as a sustainable model for providing specialty support to PCPs in communities with limited access to endocrinologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Democratizing type 1 diabetes specialty care in the primary care setting to reduce health disparities: project extension for community healthcare outcomes (ECHO) T1D. Walker, AF., Cuttriss, N., Haller, MJ., et al.[2021]

Families of children with type 1 diabetes mellitus (DM1) face a significant economic burden, with an average annual direct cost of $1689.87 for treatment and monitoring, which is notably high compared to the minimum wage in Mexico.

The largest portion of these costs comes from self-monitoring of blood glucose (53.0%) and insulin (14.8%), and families of children with poor metabolic control incur even higher costs due to less frequent blood glucose monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic family burden of metabolic control in children and adolescents with type 1 diabetes mellitus. Altamirano-Bustamante, N., Islas-Ortega, L., Robles-Valdés, C., et al.[2019]

Achieving glycemic targets in patients with type 1 diabetes (T1D) remains challenging, highlighting the need for quality improvement (QI) methodologies to enhance management strategies and patient outcomes.

The article emphasizes the importance of self-management and technology integration in T1D care, proposing novel QI interventions that can improve glycemic control and patient experiences, particularly in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health-system-based interventions to improve care in pediatric and adolescent type 1 diabetes. Corathers, SD., Schoettker, PJ., Clements, MA., et al.[2018]

The T1D Financial Toolkit, designed for emerging adults aged 18 to 25 with type 1 diabetes, was found to be feasible and acceptable, with 36 out of 39 participants completing the study and expressing high satisfaction with the toolkit's content and design.

Participants recommended enhancing the toolkit by incorporating more practical problem-solving elements, indicating that while the toolkit is effective, there is room for improvement to better support self-management in diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility and Acceptability of a Community-Developed Health Insurance and Financial Toolkit for Emerging Adults With Type 1 Diabetes. Blanchette, JE., Allen, NA., Litchman, ML.[2022]

The life expectancy of individuals with type 1 diabetes has improved significantly, increasing by over 15 years in the past 40 years, primarily due to better management of nephropathy, which should be considered when determining life insurance premiums.

Type 1 diabetic patients do not have a higher risk of accidents compared to nondiabetic individuals, suggesting that they should be eligible for accident insurance at standard rates without increased premiums.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving prognosis of type 1 diabetes. Mortality, accidents, and impact on insurance. Borch-Johnsen, K.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06348160

iHERO Study: Insurance, Health and Economic Resources ... This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes.

2. ctv.veeva.com ctv.veeva.com/study/ihero-study-insurance-health-and-economic-resources-online-for-emerging-adults-with-type-1-diabete

IHERO Study: Insurance, Health and Economic Resources ... This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes.

3. uhhospitals.org uhhospitals.org/uh-research/find-clinical-trials-and-studies/clinical-trials-search/ihero-20755

iHERO Study The purpose of this study is to understand the effects of a financial and health insurance literacy (HIL) toolkit on HIL, financial stress, and diabetes self- ...

4. withpower.com withpower.com/trial/phase-type-1-diabetes-mellitus-4-2024-7853b

iHERO Toolkit for Type 1 Diabetes The iHERO Toolkit is unique because it focuses on providing financial stress and health insurance education specifically for young adults with Type 1 Diabetes, ...

5. app.trialscreen.org app.trialscreen.org/trials/ihero-insurance-health-economic-resources-online-emerging-adults-type-trial-nct06348160

iHERO Study: Insurance, Health and Economic Resources ... This study aims to evaluate the impact of the iHERO Toolkit, an online resource developed with the diabetes community, on diabetes self-management, financial ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06348160/ihero-study-insurance-health-and-economic-resources-online-for-emerging-adults-with-type-1-diabetes

IHERO Study: Insurance, Health and Economic Resources ... This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes.