Diabetes Mellitus, Type 1
Conditions
Keywords
T1D, Diabetes, Diabetes Mellitus, Type 1
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALDREAM intervention
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.
Sponsors
University of California, San Francisco
Children's Hospital Los Angeles
University of California, Davis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Intervention group (will receive VPG curriculum) versus comparator group (not enrolled)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Adolescents 13-17 years old and their caregivers * Adolescent must have T1D of any duration, and be receiving diabetes care at UCSF, CHLA or UC Davis * Self-identify as Latina/o/x or other variations such as Hispanic * Preferred language of English or Spanish
Exclusion criteria
* Participants who have a medical, developmental, or psychiatric condition that would make peer group participation difficult * Adolescents who are planning to transfer care to a different medical center within the next year, which would prevent assessment of longitudinal outcomes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Survey | Baseline | Captures personal and family background (e.g. gender, income) |
| Caregiver Phase 2 Intervention Survey - "Feedback Survey" | End of Study to (6-15 months) | Assess various intervention components (e.g., frequency of virtual peer groups, in person events). |
| Caregiver In Person Event Evaluation | Throughout the study, up to 15 months | Captures in the moment in person event feedback (e.g., improve experience and components). |
| Caregiver Online Group Evaluation | Throughout the study, up to 15 months | Captures moment group feedback (e.g., improve experience and content). |
| Adolescent Survey | Baseline | Captures diabetes technology, personal and family background (e.g., diabetes technology history, gender). |
| Adolescent Phase 2 Intervention Survey - "Feedback Survey" | End of Study (6-15 months) | Assess various intervention components (e.g, frequency of virtual peer groups, in person events). |
| Adolescent In Person Event Evaluation | Throughout the study, up to 15 months | Captures in the moment in person event feedback (e.g., improve experience and components). |
| Adolescent Online Group Evaluation | Throughout the study, up to 15 months | Captures moment group feedback (e.g., improve experience and content). |
| Attendance at VPG and in-person events | Throughout the study, up to 15 months | Attendance will be recorded for each in person and online events |
| Retention of enrolled patients | End of Study (6-15 months) | Engagement of participants throughout study trajectory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver Diabetes Distress Scale (DDS) | Baseline and End of Study (6-15 months) | 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. |
| Caregiver Diabetes Family Conflict Scale (DFCS) | Baseline and End of Study (6-15 months) | Measures negative emotions around BGM, quality of life, and perceived parental burden from diabetes management; 3-point Likert scale, higher score indicating more conflict. |
| Caregiver Health Care Relationship (QHR) | Baseline and End of Study (6-15 months) | Captures interactions with medical team, response options for each item were provided on a 5-point Likert scale in various formats. |
| Patient Health Utilization | Baseline, 3-months, 6-months, 9-months, End of Study 12 to 15-months | Asks about any interval ED or hospital utilization over the prior 3 months |
| Adolescent Diabetes Distress Scale (DDS) | Baseline and End of Study (6-15 months) | Measures diabetes emotional distress; response options for each item were provided on a 5-point Likert scale, higher score indicated more distress. |
| Adolescent Benefits and Burdens of CGM (BenCGM & BurCGM) | Baseline and End of Study (6-15 months) | Measures benefits and burdens of continuous glucose monitoring in adolescents; 5-point Likert scale. |
| Adolescent Diabetes Family Conflict Scale, (DFCS) | Baseline and End of Study (6-15 months) | Measures negative emotions around BGM, quality of life, and perceived parental burden from diabetes management, 3-point Likert scale, higher score indicating more conflict. |
| Adolescent Diabetes Strengths and Resilience Measure (DSTAR) | Baseline and End of Study (6-15 months) | Captures adaptive aspects of adolescents' diabetes management (i.e., "strengths"), and is related to clinical outcomes, 5-point Likert scale. |
| Adolescent BenPump/Pod & BurPump/Pod | Baseline and End of Study (6-15 months) | Measures benefits and burdens of pump/pods monitoring in adolescents, 5-point Likert scale. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJenise C Wong, MD, PhD
University of California, San Francisco
Outcome results
None listed