Trial results for the Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D) study were posted on ClinicalTrials.gov on 2026-03-12, with 217 participants enrolled. The behavioral/psychoeducational intervention demonstrated statistically significant improvements in Time in Range at 6 and 9 months compared to the control group.
Background
Type 1 Diabetes (T1D) is a chronic autoimmune condition requiring lifelong insulin management. Adolescents and young adults with T1D often face significant challenges, including diabetes distress, which can impact glycemic control and overall well-being. Behavioral and psychoeducational interventions are designed to support self-management, reduce distress, and improve health outcomes in this population. Optimizing short-term and long-term health for young people with T1D is a critical area of focus in diabetes care.
Trial design
This completed study, designated as Phase NA, enrolled 217 participants with Type 1 Diabetes. The trial assessed the impact of a behavioral/psychoeducational intervention aimed at reducing diabetes distress and improving glycemic outcomes in adolescents and young adults aged 14-25 years. Participants were randomized into either an intervention group or a control group over a 2-year period.
Key results
The trial reported key measurements for Time in Range (TIR) and A1c:
- Time in Range (TIR) (Percent of time):
- At Month 0, the Intervention Group had a mean TIR of 50.1% (Standard Deviation 17.2%) compared to the Control Group's 47.2% (Standard Deviation 16.3%). A t-test, 2 sided, yielded a p-value of 0.224.
- At Month 3, the Intervention Group had a mean TIR of 53.8% (Standard Deviation 14.9%) compared to the Control Group's 50.3% (Standard Deviation 15.0%). A t-test, 2 sided, yielded a p-value of 0.115.
- At Month 6, the Intervention Group had a mean TIR of 56.5% (Standard Deviation 12.6%) compared to the Control Group's 49.9% (Standard Deviation 14.3%). A t-test, 2 sided, yielded a p-value of 0.002.
- At Month 9, the Intervention Group had a mean TIR of 56.0% (Standard Deviation 13.6%) compared to the Control Group's 50.3% (Standard Deviation 14.9%). A t-test, 2 sided, yielded a p-value of 0.009.
- At Month 12, the Intervention Group had a mean TIR of 55.7% (Standard Deviation 13.1%) compared to the Control Group's 52.9% (Standard Deviation 15.5%). A t-test, 2 sided, yielded a p-value of 0.208.
- A1c (A1c %):
- The Intervention Group had a mean A1c of 7.9% (Standard Deviation 1.3%) compared to the Control Group's 8.1% (Standard Deviation 1.2%). A t-test, 2 sided, for Month 0 (Intervention vs. Control) yielded a p-value of 0.422.
What this means
The results indicate that the HAPPY T1D behavioral/psychoeducational intervention significantly improved Time in Range (TIR) for adolescents and young adults with Type 1 Diabetes at the 6-month and 9-month marks. While the A1c values showed a numerically lower mean in the intervention group, this difference was not statistically significant based on the provided p-value. The statistically significant improvements in TIR suggest that this type of intervention can positively impact glycemic control, which is crucial for managing Type 1 Diabetes and optimizing long-term health outcomes in this age group.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05413239, titled "Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)", were posted on 2026-03-12 on clinicaltrials.gov.