Clinical trial NCT06546930: Device Use Reimagined Through Education And Mentorship
Official title: Optimizing Diabetes Technology Use for Latinx Youth Through DREAM (Device Use Reimagined Through Education And Mentorship) Virtual Peer Groups [Study-wide] - DREAM Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: T1D
Diabetes
Diabetes Mellitus
Type 1
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Children's Hospital Los Angeles
name: University of California, Davis
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Intervention group (will receive VPG curriculum) versus comparator group (not enrolled)
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver Survey
timeFrame: Baseline
measure: Caregiver Phase 2 Intervention Survey - "Feedback Survey"
timeFrame: End of Study (12-15 months)
measure: Caregiver In Person Event Evaluation
timeFrame: Throughout the study completion, up to 15 months
measure: Caregiver Online Group Evaluation
timeFrame: Throughout the study completion, up to 15 months
measure: Adolescent Survey
timeFrame: Baseline
measure: Adolescent Phase 2 Intervention Survey - "Feedback Survey"
timeFrame: End of Study (12-15 months)
measure: Adolescent In Person Event Evaluation
timeFrame: Throughout the study completion, up to 15 months
measure: Adolescent Online Group Evaluation
timeFrame: Throughout the study completion, up to 15 months
measure: Attendance at VPG and in-person events
timeFrame: Throughout the study completion, up to 15 months
measure: Retention of enrolled patients
timeFrame: End of Study (12-15 months)
Secondary outcomes:
measure: Caregiver Diabetes Distress Scale (DDS)
timeFrame: Baseline and End of Study (12-15 months)
measure: Caregiver Diabetes Family Conflict Scale (DFCS)
timeFrame: Baseline and End of Study (12-15 months)
measure: Caregiver Health Care Relationship (QHR)
timeFrame: Baseline and End of Study (12-15 months)
measure: Patient Health Utilization
timeFrame: Baseline, 3-months, 6-months, 9-months, End of Study 12 to 15-months
measure: Adolescent Diabetes Distress Scale (DDS)
timeFrame: Baseline and End of Study (12-15 months)
measure: Adolescent Benefits and Burdens of CGM (BenCGM & BurCGM)
timeFrame: Baseline and End of Study (12-15 months)
measure: Adolescent Diabetes Family Conflict Scale, (DFCS)
timeFrame: Baseline and End of Study (12-15 months)
measure: Adolescent Diabetes Strengths and Resilience Measure (DSTAR)
timeFrame: Baseline and End of Study (12-15 months)
measure: Adolescent BenPump/Pod & BurPump/Pod
timeFrame: Baseline and End of Study (12-15 months)
Other outcomes:
measure: Socio-Demographic History
timeFrame: Baseline
measure: Diabetes Technology Use
timeFrame: Baseline and End of Study (12-15 months)
measure: Number of participants completing rountine appointments
timeFrame: Baseline and End of Study (12-15 months)
measure: Hemoglobin A1c
timeFrame: Baseline and End of Study (12-15 months)
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jenise C Wong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hessler D, Fisher L, Polonsky W, Johnson N. Understanding the Areas and Correlates of Diabetes-Related Distress in Parents of Teens With Type 1 Diabetes. J Pediatr Psychol. 2016 Aug;41(7):750-8. doi: 10.1093/jpepsy/jsw002. Epub 2016 Feb 10.
citation: Manning ML, Singh H, Stoner K, Habif S. The Development and Psychometric Validation of the Diabetes Impact and Device Satisfaction Scale for Individuals with Type 1 Diabetes. J Diabetes Sci Technol. 2020 Mar;14(2):309-317. doi: 10.1177/1932296819897976. Epub 2020 Feb 6.
citation: Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626.
citation: Messer LH, Cook PF, Tanenbaum ML, Hanes S, Driscoll KA, Hood KK. CGM Benefits and Burdens: Two Brief Measures of Continuous Glucose Monitoring. J Diabetes Sci Technol. 2019 Nov;13(6):1135-1141. doi: 10.1177/1932296819832909. Epub 2019 Mar 10.
citation: Hood KK, Butler DA, Anderson BJ, Laffel LM. Updated and revised Diabetes Family Conflict Scale. Diabetes Care. 2007 Jul;30(7):1764-9. doi: 10.2337/dc06-2358. Epub 2007 Mar 19.
citation: Iturralde E, Hood KK, Weissberg-Benchell J, Anderson BJ, Hilliard ME. Assessing strengths of children with type 1 diabetes: Validation of the Diabetes Strengths and Resilience (DSTAR) measure for ages 9 to 13. Pediatr Diabetes. 2019 Nov;20(7):1007-1015. doi: 10.1111/pedi.12898. Epub 2019 Jul 29.
citation: Hilliard ME, Iturralde E, Weissberg-Benchell J, Hood KK. The Diabetes Strengths and Resilience Measure for Adolescents With Type 1 Diabetes (DSTAR-Teen): Validation of a New, Brief Self-Report Measure. J Pediatr Psychol. 2017 Oct 1;42(9):995-1005. doi: 10.1093/jpepsy/jsx086.