Device Use Reimagined Through Education And Mentorship (DREAM)

Optimizing Diabetes Technology Use for Latinx Youth Through DREAM (Device Use Reimagined Through Education And Mentorship) Virtual Peer Groups [Study-wide] - DREAM Intervention

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Behavioral: DREAM intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • University of California, Davis
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
    • San Francisco, California, United States, 94158
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Comparator Group; 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.
Experimental: Intervention; Virtual peer groups (VPGs) Six different VPGs topics will be offered. Each VPG topic will be presented separately to youth and caregivers, in Spanish and English. Frequency of scheduling for each VPG will vary on a month-to-month basis depending on the distribution of current enrollees who have not yet discussed that topic and the availability of the relevant facilitators. In-Person Events Optional in-person events may be offered quarterly during the 6-12 month study participation period.	Behavioral: DREAM 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Survey	Captures personal and family background (e.g. gender, income)	Baseline
Adolescent Survey	Captures diabetes technology, personal and family background (e.g., diabetes technology history, gender).	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 to (6-15 months)
Caregiver In Person Event Evaluation	Captures in the moment in person event feedback (e.g., improve experience and components).	Throughout the study, up to 15 months
Caregiver Online Group Evaluation	Captures moment group feedback (e.g., improve experience and content).	Throughout the study, up to 15 months
Adolescent Phase 2 Intervention Survey - "Feedback Survey"	Assess various intervention components (e.g, frequency of virtual peer groups, in person events).	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).	Throughout the study, up to 15 months
Adolescent Online Group Evaluation	Captures moment group feedback (e.g., improve experience and content).	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	Throughout the study, up to 15 months
Retention of enrolled patients	Engagement of participants throughout study trajectory	End of Study (6-15 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 (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.	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.	Baseline and End of Study (6-15 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 (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.	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.	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.	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.	Baseline and End of Study (6-15 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (6-15 months)
Number of participants completing rountine appointments	Electronic Medical Record (EMR) Abstraction	Baseline and End of Study (6-15 months)
Hemoglobin A1c	Lab results	Baseline and End of Study (6-15 months)

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of California, Davis; Children's Hospital Los Angeles
• Investigators: Principal Investigator: Jenise C Wong, MD, PhD, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes; Diabetes Mellitus; T1D; Type 1
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 24-41906; 5R01DK135000 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No