Trial results for a study investigating adherence barriers in adolescents with Type 1 Diabetes were posted on ClinicalTrials.gov on 2025-07-15, involving 195 participants.
Background
Type 1 Diabetes (T1D) requires rigorous daily management, and adherence to treatment regimens can be particularly challenging for adolescents. Factors such as stress, time pressure, and the impact of the condition on daily life can significantly affect a young person's ability to consistently manage their diabetes. Interventions aimed at addressing these specific adherence barriers are crucial for improving health outcomes and quality of life for adolescents living with T1D. This study explored a web-based approach to support adherence.
Trial design
This completed study, designated as Phase NA, enrolled 195 participants to investigate conditions including Type 1 Diabetes and Adherence, Patient. The trial examined a web-based intervention called "Diabetes Journey" designed to address adherence barriers in adolescents with T1D. Participants were compared against an Enhanced Standard of Care group.
Key results
The trial reported several key measurements across both the "Diabetes Journey" intervention group and the "Enhanced Standard of Care" group:
- Barriers to Diabetes Adherence Questionnaire-Youth Report Stress/Burnout Subscale (score on a scale):
- Diabetes Journey group: Mean score of 2.36 (Standard Deviation 0.90).
- Enhanced Standard of Care group: Mean score of 2.31 (Standard Deviation 1.05).
- Barriers to Diabetes Adherence Questionnaire - Youth Report Time Pressure/Planning Subscale (score on a scale):
- Diabetes Journey group: Mean score of 1.92 (Standard Deviation 0.58).
- Enhanced Standard of Care group: Mean score of 2.03 (Standard Deviation 0.89).
- Hemoglobin A1C (percentage of glycosylated hemoglobin):
- Diabetes Journey group: Mean value of 8.06 (Standard Deviation 1.72).
- Enhanced Standard of Care group: Mean value of 7.98 (Standard Deviation 1.67).
- Type 1 Diabetes and Life -Youth Report (score on a scale):
- Diabetes Journey group: Mean score of 65.84 (Standard Deviation 14.71).
- Enhanced Standard of Care group: Mean score of 65.82 (Standard Deviation 18.32).
What this means
The posted results provide preliminary data on the impact of the "Diabetes Journey" web-based intervention on several key metrics for adolescents with Type 1 Diabetes. The measurements include mean scores for stress/burnout and time pressure/planning adherence barriers, Hemoglobin A1C levels, and a general quality of life score. While specific comparative analyses or statistical significance values are not reported, these initial findings offer insights into the observed outcomes in both the intervention and enhanced standard of care groups, contributing to the understanding of such digital health tools in T1D management.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04404556, titled "Diabetes Journey: An Adolescent Adherence Barriers Intervention", were posted on 2025-07-15 on clinicaltrials.gov.