N/A
N=162
Diabetes Journey: An Adolescent Adherence Barriers Intervention
Type 1 Diabetes · Adherence, Patient
Bottom Line
View on ClinicalTrials.gov: NCT04404556 ↗Enrolled (actual)
162
Serious AEs
0.6%
Results posted
Jul 2025
Primary outcome: Primary: Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale — 2.36; 2.31 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diabetes Journey (Behavioral); Enhanced Standard of Care (Behavioral)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale |
2.36; 2.31 | — |
| PRIMARY Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale |
1.92; 2.03 | — |
| SECONDARY Hemoglobin A1C |
8.06; 7.98 | — |
| SECONDARY Type 1 Diabetes and Life -Youth Report |
65.84; 65.82 | — |
| SECONDARY Adherence for Continuous Glucose Monitors |
— | — |
| SECONDARY Adherence |
— | — |
| SECONDARY Adherence for Insulin Pump Users |
— | — |
| SECONDARY Adherence to Insulin Boluses |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04404556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.