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Type 1 DiabetesNCT04404556

Diabetes Journey: An Adolescent Adherence Barriers Intervention

A study testing Diabetes Journey in people with Type 1 Diabetes and Adherence, Patient, run by Children's Hospital Medical Center, Cincinnati at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Type 1 Diabetes, Adherence, Patient
What is being tested?
Diabetes Journey
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
2 sitesUnited States
Study dates
10 Aug 2020to 31 Mar 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • T1D diagnosis >1 year
  • Adolescents with T1D ages 13-17
  • Elevations on the Barriers to Diabetes Adherence questionnaire (scores of ≥3 of 53 for the Stress/Burnout and/or Time Pressure/Planning subscales) based on their previous clinic visit scores
  • Ability to read/speak English (all measures are in English)

Who cannot join

  • Diagnosis of significant developmental disorders (e.g., autism spectrum disorder, moderate/severe developmental or intellectual disability)
  • Comorbid medical diagnoses (e.g., cystic fibrosis, asthma) with the exception of endocrine disorders (e.g., Celiac disease, thyroid)
  • No use of/plans to use non-insulin medication for blood glucose control

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • University of Florida

    Gainesville, Florida, 32610-0165

Other trials in United States

About this study

Official title: Diabetes Journey: An Intervention to Improve Adherence Barriers for Adolescents With Type 1 Diabetes

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a web-based intervention addressing adherence barriers in adolescents with T1D.

Read the detailed description

Type 1 diabetes (T1D) treatment adherence is complex and involves glucose monitoring, counting carbohydrates, and intensive insulin delivery via injections or insulin pump in response to food intake, exercise, and illness to achieve near-normal blood glucose levels. Evidence demonstrates that adhering to T1D treatment is challenging, especially during adolescence. Non-adherence leads to suboptimal glycemic levels that severely compromise health and quality of life. Suboptimal adherence to T1D treatment regimen is common in >50% of adolescents and directly related to suboptimal glycemic control, increased risk of hospitalizations for diabetic ketoacidosis, and decreased health-related quality of life (HRQOL). The maximum benefits of current diabetes technology are limited by the knowledge, skills, adherence barriers, and non-adherence behaviors.10-14 Ultimately, adolescents have to overcome these barriers in order to benefit from technological advances. Thus, there is a clear need for behaviorally focused interventions to identify and reduce adherence barriers. The overall objective of this study is to identify adolescents with elevated adherence barriers and provide novel tailored mHealth intervention (Diabetes Journey) targeting these barriers. This study is two phases and includes a small pilot of up to 12 adolescents with type 1 diabetes (Phase 1) and a randomized controlled clinical trial (Phase 2). The randomized controlled clinical trial will examine feasibility, acceptability and preliminary efficacy of Diabetes Journey versus enhanced standard of care (control group) in approximately 256 adolescents with type 1 diabetes. Primary and secondary outcomes include adherence barriers, adherence, health-related quality of life and A1C. Satisfaction and acceptability will also be examined. Mediators and moderators will include executive functioning, diabetes distress, family conflict, depressive symptoms, fear of hypoglycemia and sleep.

Being tested
Diabetes Journey, Enhanced Standard of Care
Keywords
Adolescent, mHealth, executive functioning skills, adherence barriers
Medical subject headings
Diabetes Mellitus, Type 1, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diabetes JourneyBehavioural

    Also called mHealth problem-solving adherence barriers intervention

    Web-based telehealth intervention focused on adherence barriers and problem-solving

  • Enhanced Standard of CareBehavioural

    Also called t1dtoolkit

    General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.

Study groups in NCT04404556
Study groupRoleWhat they receive
Diabetes JourneyExperimentalDiabetes Journey is a web-based intervention to address key adherence barriers. Participants randomized to this arm will first receive the mandatory Introduction and Problem-Solving Module. Based on their elevations on the Barriers to Diabetes Adherence measure, participants will receive up to 7 modules in total. Participants will navigate through the web-based theme park map and complete modules independently and then will have accompanying Zoom telehealth sessions with a therapist.
Receives: Behavioral: Diabetes Journey
Enhanced Standard of CareActive comparatorParticipants randomized to Enhanced Standard of Care will receive general education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) from each site across 12-weeks. Content to address adherence barriers were modified and or newly developed for the Enhanced Standard of Care group via the T1DToolkit website.
Receives: Behavioral: Enhanced Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale

    Stress and Burnout Scale - assesses frustration and feeling burned out by diabetes and its management. Score range from 1-5, with higher scores representing greater barriers.

    Measured: 6-month follow-up

  2. Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale

    Time Pressure and Planning Subscale - assesses the time and energy it takes to plan for diabetes self-management, including carrying supplies and making management decisions. Score range from 1-5, with higher scores representing greater barriers.

    Measured: 6-month follow-up

Secondary outcomes (6)

  1. Hemoglobin A1C

    A blood test that measures the average blood sugar levels over the past two to three months.

    Measured: 6-month follow-up

  2. Type 1 Diabetes and Life -Youth Report

    Total Quality of Life Scores range from 0-100, with higher scores indicating better quality of life

    Measured: 6-month follow-up

  3. Adherence for Continuous Glucose Monitors

    % Time in Range for those on continuous glucose monitors.

    Measured: 6-month follow-up

  4. Adherence

    # blood glucose checks per day

    Measured: 6-month follow-up

  5. Adherence for Insulin Pump Users

    # carbohydrate entries per day for insulin pump users

    Measured: 6-month follow-up

  6. Adherence to Insulin Boluses

    The average of the frequency of insulin boluses delivered per day

    Measured: 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2020
  2. Study start10 Aug 2020
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to one of two conditions: 1) Diabetes Journey or 2) Enhanced Standard of Care.
Masking
Single blind
Who is masked
Care provider
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04404556
Sponsor's protocol ID
2020-0162
Other IDs
R01DK121295
Status last verified
Jun 2025
First submitted
19 May 2020
Last updated
15 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The NIDDK Data Repository will serve as the primary data repository for the current proposal.

Publications

  • Modi AC, Mara CA, O'Donnell H, Schmidt M, Kichler JC, Smith LB, Westen SC, Jacobsen L, Corathers SD, Williford DN, Trojanowski PJ, Flynn E, Shaffer ER, Tanner B, Driscoll KA. A Pilot Randomized Controlled Clinical Trial to Improve Adherence Barriers for Adolescents with Type 1 Diabetes. J Pediatr. 2026 Aug;295:115155. doi: 10.1016/j.jpeds.2026.115155. Epub 2026 May 22.

    PubMed 42176729

Questions about this trial

What is this clinical trial studying?

A study testing Diabetes Journey in people with Type 1 Diabetes and Adherence, Patient, run by Children's Hospital Medical Center, Cincinnati at 2 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: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale (time frame: 6-month follow-up). The study lists 2 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 NCT04404556, which also lists 1 linked publication.

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 15 Jul 2025.

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