Type 1 DiabetesNCT06348160
iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes
A study testing iHERO Toolkit Resource in people with Type 1 Diabetes, run by University Hospitals Cleveland Medical Center at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- iHERO Toolkit Resource
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 May 2024to 22 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University Hospitals
Cleveland, Ohio, 44106
University of Florida Diabetes Institute
Gainesville, Florida, 32610
Children's Hospital Los Angeles
Los Angeles, California, 90027
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
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.
- Conditions
- Type 1 Diabetes
- Being tested
- iHERO Toolkit Resource
- Keywords
- Type 1 diabetes, Health insurance, Financial stress, Young adults, Health insurance literacy
- Medical subject headings
- Diabetes Mellitus, Type 1, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iHERO Toolkit ResourceBehavioural
iHERO Toolkit consists of micro-videos and supplemental online resources. Participants will have access to the toolkit housed on pathfactory for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| iHERO Resource Group | Experimental | Toolkit consisting of micro-videos and supplemental online resources. Receives: Behavioral: iHERO Toolkit Resource |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in financial stress as measured by the Personal Financial Well-Being Scale© (PFW) Scale (PFW)
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.
Measured: Baseline, 1 month, 6 months, 12 months
Change in health insurance literacy as measured by The Health Insurance Literacy Measure (HILM) Measure (HILM)
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.
Measured: 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.
T1DAL-Young Adult and T1DAL- Adult are scored on a scale of 0-100 with higher scores indicating better health related quality of life.
Measured: 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
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.
Measured: Baseline, 1 month, 6 months, 12 months
Change in HbA1c levels as measured by self-collect capillary HbA1c
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start14 May 2024
- Primary completion22 Nov 2026 (estimated)
- Study completion22 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Principal investigator, Julia Blanchette, University Hospitals Cleveland Medical Center
- Investigators
- Julia Blanchette, PhD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348160
- Sponsor's protocol ID
- STUDY20230187
- Status last verified
- Jan 2026
- First submitted
- 29 Mar 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blanchette JE, Toly VB, Wood JR. Financial stress in emerging adults with type 1 diabetes in the United States. Pediatr Diabetes. 2021 Aug;22(5):807-815. doi: 10.1111/pedi.13216. Epub 2021 May 18.
PubMed 33887095Blanchette JE, Allen NA, Litchman ML. The Feasibility and Acceptability of a Community-Developed Health Insurance and Financial Toolkit for Emerging Adults With Type 1 Diabetes. Sci Diabetes Self Manag Care. 2022 Jun;48(3):174-183. doi: 10.1177/26350106221087474. Epub 2022 Mar 15.
PubMed 35287511
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06348160
- Acronym / sponsor ID
- STUDY20230187
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Health insurance, Financial stress, Young adults, Health insurance literacy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 14 May 2024 (actual)
- Primary completion
- 22 Nov 2026 (estimated)
- Study completion
- 22 Nov 2026 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iHERO Resource Group | Experimental | Behavioral: iHERO Toolkit ResourceToolkit consisting of micro-videos and supplemental online resources. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iHERO Toolkit ResourceiHERO Toolkit consists of micro-videos and supplemental online resources. Participants will have access to the toolkit housed on pathfactory for 30 days. | Behavioural | iHERO Resource Group |
Primary outcome
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.
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.
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.
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.
Change in HbA1c levels as measured by self-collect capillary HbA1c
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Background: PubMed 33887095Blanchette JE, Toly VB, Wood JR. Financial stress in emerging adults with type 1 diabetes in the United States. Pediatr Diabetes. 2021 Aug;22(5):807-815. doi: 10.1111/pedi.13216. Epub 2021 May 18.
- Background: PubMed 35287511Blanchette JE, Allen NA, Litchman ML. The Feasibility and Acceptability of a Community-Developed Health Insurance and Financial Toolkit for Emerging Adults With Type 1 Diabetes. Sci Diabetes Self Manag Care. 2022 Jun;48(3):174-183. doi: 10.1177/26350106221087474. Epub 2022 Mar 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Blanchette, PhD principal investigator
University Hospitals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iHERO Toolkit Resource in people with Type 1 Diabetes, run by University Hospitals Cleveland Medical Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06348160, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.