CClinicalTrials.gg
Active, not recruitingNCT06546930DREAMUpdated May 1, 2026

Device Use Reimagined Through Education And Mentorship

An interventional study of DREAM intervention in Diabetes Mellitus, Type 1, sponsored by University of California, San Francisco. Active, not recruiting at 3 sites in United States. Open to participants aged 13 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-05-01.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
13 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus, Type 1

Keywords

  • T1D
  • Diabetes
  • Diabetes Mellitus
  • Type 1
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 120 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 17 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • 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

  • 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.

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.

06

What researchers measure

Primary outcomes

  1. Caregiver Survey

    Captures personal and family background (e.g. gender, income)

    Time frame: Baseline

  2. Caregiver Phase 2 Intervention Survey - "Feedback Survey"

    Assess various intervention components (e.g., frequency of virtual peer groups, in person events).

    Time frame: End of Study to (6-15 months)

  3. Caregiver In Person Event Evaluation

    Captures in the moment in person event feedback (e.g., improve experience and components).

    Time frame: Throughout the study, up to 15 months

  4. Caregiver Online Group Evaluation

    Captures moment group feedback (e.g., improve experience and content).

    Time frame: Throughout the study, up to 15 months

  5. Adolescent Survey

    Captures diabetes technology, personal and family background (e.g., diabetes technology history, gender).

    Time frame: Baseline

  6. Adolescent Phase 2 Intervention Survey - "Feedback Survey"

    Assess various intervention components (e.g, frequency of virtual peer groups, in person events).

    Time frame: End of Study (6-15 months)

  7. Adolescent In Person Event Evaluation

    Captures in the moment in person event feedback (e.g., improve experience and components).

    Time frame: Throughout the study, up to 15 months

  8. Adolescent Online Group Evaluation

    Captures moment group feedback (e.g., improve experience and content).

    Time frame: Throughout the study, up to 15 months

  9. Attendance at VPG and in-person events

    Attendance will be recorded for each in person and online events

    Time frame: Throughout the study, up to 15 months

  10. Retention of enrolled patients

    Engagement of participants throughout study trajectory

    Time frame: End of Study (6-15 months)

Secondary outcomes

  1. 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.

    Time frame: Baseline and End of Study (6-15 months)

  2. 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.

    Time frame: Baseline and End of Study (6-15 months)

  3. 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.

    Time frame: Baseline and End of Study (6-15 months)

  4. Patient Health Utilization

    Asks about any interval ED or hospital utilization over the prior 3 months

    Time frame: Baseline, 3-months, 6-months, 9-months, End of Study 12 to 15-months

  5. 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.

    Time frame: Baseline and End of Study (6-15 months)

  6. Adolescent Benefits and Burdens of CGM (BenCGM & BurCGM)

    Measures benefits and burdens of continuous glucose monitoring in adolescents; 5-point Likert scale.

    Time frame: Baseline and End of Study (6-15 months)

  7. 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.

    Time frame: Baseline and End of Study (6-15 months)

  8. 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.

    Time frame: Baseline and End of Study (6-15 months)

  9. Adolescent BenPump/Pod & BurPump/Pod

    Measures benefits and burdens of pump/pods monitoring in adolescents, 5-point Likert scale.

    Time frame: Baseline and End of Study (6-15 months)

Other outcomes

  1. Socio-Demographic History

    Self-reported demographic history (gender, age, race, household income, etc) will be collected.

    Time frame: Baseline

  2. Diabetes Technology Use

    Diabetes technology use history self-reported and Electronic Medical Record (EMR) Abstraction

    Time frame: Baseline and End of Study (6-15 months)

  3. Number of participants completing rountine appointments

    Electronic Medical Record (EMR) Abstraction

    Time frame: Baseline and End of Study (6-15 months)

  4. Hemoglobin A1c

    Lab results

    Time frame: Baseline and End of Study (6-15 months)

07

Study locations

3 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 26869664 ↗
  • 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. PubMed 32028790 ↗
  • 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. PubMed 15735199 ↗
  • 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. PubMed 30854886 ↗
  • 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. PubMed 17372149 ↗
  • 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. PubMed 31336011 ↗
  • 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. PubMed 28549160 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06546930
Lead 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)
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Oct 11, 2024
Primary completion
Jul 31, 2026 (estimated)
Completion
Jul 31, 2026 (estimated)
Last update
May 1, 2026

Study contacts

Jenise C Wong, MD, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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