Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)
- Conditions
- Type 1 Diabetes
- Interventions
- Behavioral: Psychoeducation to reduce diabetes distress and improve glycemic outcomes
- Registration Number
- NCT05413239
- Lead Sponsor
- Joslin Diabetes Center
- Brief 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.
- Detailed Description
In this study, we will recruit 180 adolescents and young adults (ages 14-25) with type 1 diabetes for at least 1 year and suboptimal diabetes control (A1c 7-13%) to participate in a 2-year randomized clinical trial aimed at reducing diabetes distress and improving glycemic outcomes. Adolescents and young adults with type 1 diabetes represent a population that often has uncontrolled diabetes with elevated A1c levels and experiences diabetes distress, making such patients ideal for this study. Participants will be randomly assigned to one of two groups (control or intervention). The intervention group will participate in monthly intervention sessions with a research assistant during the first year of the study. Four sessions will focus on improving glycemic outcomes and 8 sessions will focus on reducing diabetes distress. The sessions will be conducted face-to-face or remotely. To ensure adequate recruitment and retention, the control group will participate in the intervention sessions during the second year of the study. Participants in both groups will use continuous glucose monitoring (CGM), with CGM data downloaded every 3 months. Participants in both groups will complete surveys and have A1c measured every 6 months. We will compare the two groups on percent time in target glucose range (70-180 mg/dL), A1c, and diabetes distress from baseline to 1 year. We hypothesize that the intervention group will have an improvement in percent time in range, A1c, and diabetes distress, compared with the control group.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 191
- 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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention Group Psychoeducation to reduce diabetes distress and improve glycemic outcomes The Intervention Group will receive the monthly intervention sessions during the first year of the study.
- Primary Outcome Measures
Name Time Method Time in Range (TIR) 0, 3, 6, 9, 12, 15, 18, 21, and 24 months CGM data will be downloaded every 3 months to assess percent time in range (TIR) (70-180 mg/dL). The primary outcome will be change in TIR from 0 to 12 months for intervention group vs. control group.
- Secondary Outcome Measures
Name Time Method Diabetes distress 0, 6, 12, 18, and 24 months Diabetes distress will be assessed every 6 months using the validated Problem Areas in Diabetes - Pediatric survey (PAID-Peds) and the Diabetes Distress Scale. Change in diabetes distress from 0 to 12 months will be compared within and between the intervention group and control group.
Attitudes toward diabetes device use 0, 6, 12, 18, and 24 months Attitudes toward diabetes device use will be assessed every 6 months using the validated Glucose Monitoring Satisfaction Survey and the Diabetes Technology Attitudes Scale. Change in attitudes toward device use from 0 to 12 months will be compared within and between the intervention group and control group.
A1c 0, 6, 12, 18, and 24 months A1c will be assessed every 6 months. Blood samples will be collected locally using uniform procedures and sent to the central laboratory at the University of Minnesota for analysis. Change in A1c from 0 to 12 months will be compared within and between the intervention group and control group.
Trial Locations
- Locations (2)
Stanford University
🇺🇸Palo Alto, California, United States
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States