N/A
N=191
Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05413239 ↗Enrolled (actual)
191
Serious AEs
8.1%
Results posted
Mar 2026
Primary outcome: Primary: Time in Range (TIR) — 50.1; 47.2; 53.8; 50.3 Percent of time — p=.224
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Psychoeducation to reduce diabetes distress and improve glycemic outcomes (Behavioral)
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- Joslin Diabetes Center
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Range (TIR) |
50.1; 47.2; 53.8; 50.3; 56.5; 49.9 | .224 |
| SECONDARY A1c |
7.9; 8.1; 7.5; 7.9; 7.6; 7.9 | .422 |
| SECONDARY Diabetes Distress |
46.2; 51.6; 42.9; 48.2; 41.3; 46.7 | .082 |
| SECONDARY Attitudes Toward Diabetes Device Use |
3.97; 3.92; 3.98; 3.90; 3.93; 4.05 | .526 |
Summary
In this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with T1D in order to optimize their short-term and long-term health.
Eligibility Criteria
Inclusion Criteria
- Age 14-25 years
- Diagnosis of type 1 diabetes (according to ADA criteria)
- Type 1 diabetes duration ≥12 months
- A1c 7-13%
- Smartphone or regular access to wifi via computer
- Fluency in English at a 5th grade level or higher (based on investigator assessment of grade level in school or highest grade level achieved and presence in mainstream academic classes)
Exclusion Criteria
- Physical or mental health condition that in the determination of the investigators may limit the ability to fully participate in the study (e.g., autism)
- Participation in another intervention study within the last 3 months
- Currently pregnant or intending to become pregnant during the study (assessed by self-report)
Data sourced from ClinicalTrials.gov (NCT05413239). 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.