Diabetes technology, such as insulin pumps and continuous glucose monitoring devices, can help improve glucose control for people with type 1 diabetes (T1D), which keeps them at lower risk for diabetes complications, but many Latinx adolescents, who make up the largest marginalized ethnic group of youth with T1D in California, use these devices less often and have less optimal glucose control compared to White youth. In phase 1 of this project, we worked directly with Latinx youth, their families, and diabetes care team members in California to develop DREAM, Device use Reimagined through Education And Mentorship, a virtual peer group (VPG) intervention that will encourage and support the use of diabetes devices in Latinx adolescents with T1D. The goals for phase 2 (intervention) of this project are to evaluate the feasibility and acceptability of the stakeholder-informed VPG intervention, and evaluate clinical and person-centered outcomes.
This multi-site project has two phases: phase 1 involved stakeholders focus groups to assess barriers and facilitators to diabetes technology and the creation of advisory councils. Feedback was obtained and used to develop phase 2, the single arm trial. A virtual peer group curriculum is being refined and will be implemented. The aims of this project are: (1) Partner with stakeholders to design a virtual peer group (VPG) intervention to promote the initiation and continued use of diabetes technology among Latinx adolescents with T1D. (2) Evaluate the feasibility and acceptability of DREAM VPGs in a pragmatic, single arm trial. (3) Assess the effects of DREAM VPGs on clinical and person-centered outcomes. Our DREAM intervention will: * Build trust/rapport and "relational connections" between participants * Empower participants to be advocates in their/their adolescents' diabetes care * Provide tools/knowledge to navigate healthcare and diabetes technology systems * Increase knowledge, confidence, and interest in using diabetes technology * Create a culturally sensitive/inclusive VPG toolkit that will be scalable, feasible, and sustainable in broader clinical contexts if found to be beneficial The DREAM project's findings will inform future efforts to improve diabetes technology use and T1D health outcomes among Latinx adolescents. If found to be effective, the VPG curriculum can be adapted for other clinic settings in order to improve education and peer support for Latinx patients and families. Future studies may extend or adapt DREAM to other cohorts, including other age groups, geographic settings, or marginalized and historically excluded populations with T1D.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
Virtual Peer Groups (VPGs) Participants will have multiple opportunities to attend a VPG on a specific topic during their 6-12 month participation period. The VPG topics will include the following: * Diabetes technology - basics or advanced use (audience-dependent) * Family relationships and diabetes * Diabetes in real life - school, work, social gatherings, travel * Wellbeing and support when living with diabetes * Working with your diabetes care team - who to call for what * Eating and activity - what's different with T1D? In-Person Events will be held quarterly to facilitate participant interaction and community-building. These gatherings will feature ice-breaker activities, refreshments, and hands-on learning opportunities, including the chance to interact with specific diabetes devices and engage with healthcare professionals and representatives from diabetes technology companies.
University of California, Davis
Davis, California, United States
RECRUITINGChildren's Hospital Los Angeles
Los Angeles, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGCaregiver Survey
Captures personal and family background (e.g. gender, income)
Time frame: Baseline
Caregiver Phase 2 Intervention Survey - "Feedback Survey"
Assess various intervention components (e.g., frequency of virtual peer groups, in person events).
Time frame: End of Study to (6-15 months)
Caregiver In Person Event Evaluation
Captures in the moment in person event feedback (e.g., improve experience and components).
Time frame: Throughout the study, up to 15 months
Caregiver Online Group Evaluation
Captures moment group feedback (e.g., improve experience and content).
Time frame: Throughout the study, up to 15 months
Adolescent Survey
Captures diabetes technology, personal and family background (e.g., diabetes technology history, gender).
Time frame: Baseline
Adolescent Phase 2 Intervention Survey - "Feedback Survey"
Assess various intervention components (e.g, frequency of virtual peer groups, in person events).
Time frame: End of Study (6-15 months)
Adolescent In Person Event Evaluation
Captures in the moment in person event feedback (e.g., improve experience and components).
Time frame: Throughout the study, up to 15 months
Adolescent Online Group Evaluation
Captures moment group feedback (e.g., improve experience and content).
Time frame: Throughout the study, up to 15 months
Attendance at VPG and in-person events
Attendance will be recorded for each in person and online events
Time frame: Throughout the study, up to 15 months
Retention of enrolled patients
Engagement of participants throughout study trajectory
Time frame: End of Study (6-15 months)
Caregiver Diabetes Distress Scale (DDS)
Measures parent-related distress, person distress, teen management distress, parent/teen relationship distress and healthcare distress, response options for each item were provided on a 5-point Likert scale, higher score indicated more distress.
Time frame: Baseline and End of Study (6-15 months)
Caregiver Diabetes Family Conflict Scale (DFCS)
Measures negative emotions around BGM, quality of life, and perceived parental burden from diabetes management; 3-point Likert scale, higher score indicating more conflict.
Time frame: Baseline and End of Study (6-15 months)
Caregiver Health Care Relationship (QHR)
Captures interactions with medical team, response options for each item were provided on a 5-point Likert scale in various formats.
Time frame: Baseline and End of Study (6-15 months)
Patient Health Utilization
Asks about any interval ED or hospital utilization over the prior 3 months
Time frame: Baseline, 3-months, 6-months, 9-months, End of Study 12 to 15-months
Adolescent Diabetes Distress Scale (DDS)
Measures diabetes emotional distress; response options for each item were provided on a 5-point Likert scale, higher score indicated more distress.
Time frame: Baseline and End of Study (6-15 months)
Adolescent Benefits and Burdens of CGM (BenCGM & BurCGM)
Measures benefits and burdens of continuous glucose monitoring in adolescents; 5-point Likert scale.
Time frame: Baseline and End of Study (6-15 months)
Adolescent Diabetes Family Conflict Scale, (DFCS)
Measures negative emotions around BGM, quality of life, and perceived parental burden from diabetes management, 3-point Likert scale, higher score indicating more conflict.
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Time frame: Baseline and End of Study (6-15 months)
Adolescent Diabetes Strengths and Resilience Measure (DSTAR)
Captures adaptive aspects of adolescents' diabetes management (i.e., "strengths"), and is related to clinical outcomes, 5-point Likert scale.
Time frame: Baseline and End of Study (6-15 months)
Adolescent BenPump/Pod & BurPump/Pod
Measures benefits and burdens of pump/pods monitoring in adolescents, 5-point Likert scale.
Time frame: Baseline and End of Study (6-15 months)