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Completed

NCT Number: NCT04404556

Diabetes Journey: An Adolescent Adherence Barriers Intervention

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.

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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Diabetes Journey

Behavioral

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

Other names: mHealth problem-solving adherence barriers intervention

Enhanced Standard of Care

Behavioral

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

Other names: t1dtoolkit

Primary outcomes

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

    Time frame: 6-month follow-up

    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.

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

    Time frame: 6-month follow-up

    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.

Secondary outcomes

  1. Hemoglobin A1C

    Time frame: 6-month follow-up

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

  2. Type 1 Diabetes and Life -Youth Report

    Time frame: 6-month follow-up

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

  3. Adherence for Continuous Glucose Monitors

    Time frame: 6-month follow-up

    % Time in Range for those on continuous glucose monitors.

  4. Adherence

    Time frame: 6-month follow-up

    # blood glucose checks per day

  5. Adherence for Insulin Pump Users

    Time frame: 6-month follow-up

    # carbohydrate entries per day for insulin pump users

  6. Adherence to Insulin Boluses

    Time frame: 6-month follow-up

    The average of the frequency of insulin boluses delivered per day

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • University of Colorado, Denver
  • University of Florida

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 27, 2020
Registry last updated
Jul 15, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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