Diabetes Journey: An Adolescent Adherence Barriers Intervention

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.

• Diabetes Journey (Behavioral), also known as mHealth problem-solving adherence barriers intervention: Web-based telehealth intervention focused on adherence barriers and problem-solving
• Enhanced Standard of Care (Behavioral), also known as t1dtoolkit: General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.

Primary outcomes

• Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale [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.
• Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale [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

• Hemoglobin A1C [6-month follow-up]: A blood test that measures the average blood sugar levels over the past two to three months.
• Type 1 Diabetes and Life -Youth Report [6-month follow-up]: Total Quality of Life Scores range from 0-100, with higher scores indicating better quality of life
• Adherence for Continuous Glucose Monitors [6-month follow-up]: % Time in Range for those on continuous glucose monitors.
• Adherence [6-month follow-up]: \# blood glucose checks per day
• Adherence for Insulin Pump Users [6-month follow-up]: \# carbohydrate entries per day for insulin pump users
• Adherence to Insulin Boluses [6-month follow-up]: The average of the frequency of insulin boluses delivered per day

Sex: All, ages: 13 Years to 17 Years

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

Participant flow

Outcome results

• Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale (Primary), Mean, score on a scale: Diabetes Journey 2.36 +/- 0.90; Enhanced Standard of Care 2.31 +/- 1.05
• Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale (Primary), Mean, score on a scale: Diabetes Journey 1.92 +/- 0.58; Enhanced Standard of Care 2.03 +/- 0.89
• Hemoglobin A1C (Secondary), Mean, percentage of glycosylated hemoglobin: Diabetes Journey 8.06 +/- 1.72; Enhanced Standard of Care 7.98 +/- 1.67
• Type 1 Diabetes and Life -Youth Report (Secondary), Mean, score on a scale: Diabetes Journey 65.84 +/- 14.71; Enhanced Standard of Care 65.82 +/- 18.32
• Adherence for Continuous Glucose Monitors (Secondary)
• Adherence (Secondary)
• Adherence for Insulin Pump Users (Secondary)
• Adherence to Insulin Boluses (Secondary)

Adverse events

Time frame: ~9 months

Serious adverse events by term

Other adverse events by term

• Results publication: 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. PMID 42176729

• Study Protocol (PDF, 2023-06-08)
• Statistical Analysis Plan (PDF, 2024-11-21)
• Informed Consent Form (PDF, 2023-06-20)

NIH grants: R01DK121295