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

January 14, 2026 updated by: Julia Blanchette, University Hospitals Cleveland Medical Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Diabetes Institute
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: iHERO Resource Group
Toolkit consisting of micro-videos and supplemental online resources.
Behavioral: iHERO Toolkit Resource
iHERO Toolkit consists of micro-videos and supplemental online resources. Participants will have access to the toolkit housed on pathfactory for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 month, 6 months, 12 months
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.
Baseline, 1 month, 6 months, 12 months
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.
Baseline, 1 month, 6 months, 12 months
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.
Baseline, 1 month, 6 months, 12 months
Change in HbA1c levels as measured by self-collect capillary HbA1c
Time Frame: Baseline, 6 months, 12 months
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Collaborators

The Leona M. and Harry B. Helmsley Charitable Trust

Investigators

  • Principal Investigator: Julia Blanchette, PhD, University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2024

Primary Completion (Estimated)

November 22, 2026

Study Completion (Estimated)

November 22, 2026

Study Registration Dates

First Submitted

March 29, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20230187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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