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NCT Number: NCT06348160

iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes

This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Behavior Behavioral Symptoms Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Financial Stress Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Stress, Psychological

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range: 18-30 years
  • Diagnosis of type 1 diabetes (T1D)
  • T1D duration for one year or longer
  • Geographical location: residing in the United States.

Exclusion criteria

  • Inability to answer questions due to cognitive status.
  • Inability to read or understand English.
  • Diagnosis of insulin-dependent diabetes that is not T1D such as cystic fibrosis-related diabetes, maturity-onset diabetes of the young, or insulin-dependent type 2 diabetes.

Treatment and study plan

iHERO Toolkit Resource

Behavioral

iHERO Toolkit consists of micro-videos and supplemental online resources. Participants will have access to the toolkit housed on pathfactory for 30 days.

Primary outcomes

  1. Change in financial stress as measured by the Personal Financial Well-Being Scale© (PFW) Scale (PFW)

    Time frame: Baseline, 1 month, 6 months, 12 months

    The PFW is an 8-item scale used to measure financial stress with a Likert scale of 1-10 with 1 being no financial stress and 10 being an overwhelming level of financial stress. Lower scores (≤ 4.4) indicate high financial stress, while scores ranging from 4.5-6.4 indicate average stress, and scores ≥ 6.5 indicate low stress.

  2. Change in health insurance literacy as measured by The Health Insurance Literacy Measure (HILM) Measure (HILM)

    Time frame: Baseline, 1 month, 6 months, 12 months

    The HILM is a 21-item measure used to rate confidence in selecting and using health insurance with 0 representing little confidence and 4 representing highest confidence. The scores of the items are summed and range from 0 to 84, with higher scores representing greater levels of health insurance literacy.

  3. Change in diabetes-specific quality of life as measured by The Type 1 Diabetes and Life Young Adult (T1DAL- Young Adult) for ages 18-25 or The Type 1 Diabetes and Life (T1DAL- Adult) for Ages 26-30.

    Time frame: Baseline, 1 month, 6 months, 12 months

    T1DAL-Young Adult and T1DAL- Adult are scored on a scale of 0-100 with higher scores indicating better health related quality of life.

  4. Change in transition navigation readiness as measured by the The Readiness for Emerging Adults with Diabetes Diagnosed in Youth (READDY) Navigation Subscale

    Time frame: Baseline, 1 month, 6 months, 12 months

    READDY navigation sub-scale scores of 1-3 indicate lower levels of confidence and scores of 4-5 indicate higher levels of confidence in healthcare navigation.

  5. Change in HbA1c levels as measured by self-collect capillary HbA1c

    Time frame: Baseline, 6 months, 12 months

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 4, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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