Device Use Reimagined Through Education And Mentorship (DREAM)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1

Treatments: Behavioral: DREAM intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06546930

24-41906

5R01DK135000 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Intervention

Experimental group

Description:

Virtual peer groups (VPGs) Six different VPGs topics will be offered on two dates (same topic) every 4-6 weeks, with topics rotating at 4-6 week intervals during their 12-month study participation period. In-Person Events Quarterly in-person events will be offered during their 12-month study participation period.

Treatment:

Behavioral: DREAM intervention

Comparator Group

No Intervention group

Description:

An equal number of eligible non-enrolled patients at each site will be selected and matched to the enrolled cohort based on age, language, HbA1c, insurance type, and diabetes technology use at a population level.