AzTrials
AzTrials

Diabetes Mellitus, Type 1DREAMNCT06546930

Device Use Reimagined Through Education And Mentorship

A study testing DREAM intervention in people with Diabetes Mellitus, Type 1, run by University of California, San Francisco at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
DREAM intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesUnited States
Study dates
11 Oct 2024to 31 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

United States3 sites
  • University of California, Davis

    Davis, California, 95616

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • University of California, San Francisco

    San Francisco, California, 94158

Other trials in United States

About this study

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

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.

Being tested
DREAM intervention
Keywords
T1D, Diabetes, Diabetes Mellitus, Type 1
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DREAM interventionBehavioural

    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.

Study groups in NCT06546930
Study groupRoleWhat they receive
InterventionExperimentalVirtual 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.
Receives: Behavioral: DREAM intervention
Comparator GroupNo interventionAn 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caregiver Survey

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

    Measured: Baseline

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

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

    Measured: 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).

    Measured: Throughout the study, up to 15 months

  4. Caregiver Online Group Evaluation

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

    Measured: Throughout the study, up to 15 months

  5. Adolescent Survey

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

    Measured: Baseline

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

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

    Measured: 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).

    Measured: Throughout the study, up to 15 months

  8. Adolescent Online Group Evaluation

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

    Measured: 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

    Measured: Throughout the study, up to 15 months

  10. Retention of enrolled patients

    Engagement of participants throughout study trajectory

    Measured: End of Study (6-15 months)

Secondary outcomes (9)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start11 Oct 2024
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Single group
Model description
Intervention group (will receive VPG curriculum) versus comparator group (not enrolled)
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06546930
Sponsor's protocol ID
24-41906
Other IDs
5R01DK135000
Acronym
DREAM
Status last verified
Apr 2026
First submitted
2 Aug 2024
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing DREAM intervention in people with Diabetes Mellitus, Type 1, run by University of California, San Francisco at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver Survey (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06546930, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in