Device Use Reimagined Through Education And Mentorship
NCT Number: NCT06546930
Acronym: DREAM
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Diabetes Mellitus, Type 1
Interventions: BEHAVIORAL: DREAM intervention
Sponsor: University of California, San Francisco
Collaborators: Children's Hospital Los Angeles|University of California, Davis|National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sex: ALL
Age: CHILD
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2026-05-31
Locations: University of California, Davis, Davis, California, 95616, United States|Children's Hospital Los Angeles, Los Angeles, California, 90027, United States|University of California, San Francisco, San Francisco, California, 94158, United States

Summary:
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.

Primary Outcome Measures: Caregiver Survey, Captures personal and family background (e.g. gender, income), Baseline|Caregiver Phase 2 Intervention Survey - "Feedback Survey", Assess various intervention components (e.g., frequency of virtual peer groups, in person events)., End of Study (12-15 months)|Caregiver In Person Event Evaluation, Captures in the moment in person event feedback (e.g., improve experience and components)., Throughout the study completion, up to 15 months|Caregiver Online Group Evaluation, Captures moment group feedback (e.g., improve experience and content)., Throughout the study completion, up to 15 months|Adolescent Survey, Captures diabetes technology, personal and family background (e.g., diabetes technology history, gender)., Baseline|Adolescent Phase 2 Intervention Survey - "Feedback Survey", Assess various intervention components (e.g, frequency of virtual peer groups, in person events)., End of Study (12-15 months)|Adolescent In Person Event Evaluation, Captures in the moment in person event feedback (e.g., improve experience and components)., Throughout the study completion, up to 15 months|Adolescent Online Group Evaluation, Captures moment group feedback (e.g., improve experience and content)., Throughout the study completion, up to 15 months|Attendance at VPG and in-person events, Attendance will be recorded for each in person and online events, Throughout the study completion, up to 15 months|Retention of enrolled patients, Engagement of participants throughout study trajectory, End of Study (12-15 months)
Secondary Outcome Measures: 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., Baseline and End of Study (12-15 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., Baseline and End of Study (12-15 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., Baseline and End of Study (12-15 months)|Patient Health Utilization, Asks about any interval ED or hospital utilization over the prior 3 months, 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., Baseline and End of Study (12-15 months)|Adolescent Benefits and Burdens of CGM (BenCGM & BurCGM), Measures benefits and burdens of continuous glucose monitoring in adolescents; 5-point Likert scale., Baseline and End of Study (12-15 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., Baseline and End of Study (12-15 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., Baseline and End of Study (12-15 months)|Adolescent BenPump/Pod & BurPump/Pod, Measures benefits and burdens of pump/pods monitoring in adolescents, 5-point Likert scale., Baseline and End of Study (12-15 months)
Other Outcome Measures: Socio-Demographic History, Self-reported demographic history (gender, age, race, household income, etc) will be collected., Baseline|Diabetes Technology Use, Diabetes technology use history self-reported and Electronic Medical Record (EMR) Abstraction, Baseline and End of Study (12-15 months)|Number of participants completing rountine appointments, Electronic Medical Record (EMR) Abstraction, Baseline and End of Study (12-15 months)|Hemoglobin A1c, Lab results, Baseline and End of Study (12-15 months)