Device Use Reimagined Through Education And Mentorship

NCT ID: NCT06546930

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-11

Study Completion Date

2026-05-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Intervention group (will receive VPG curriculum) versus comparator group (not enrolled)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DREAM intervention

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Los Angeles

OTHER

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jenise C Wong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, Davis

Davis, California, United States

Site Status RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cristina Acosta Navarro, BA

Role: CONTACT

628-224-8436

Jenise C Wong, MD, PhD

Role: CONTACT

415-476-3316

Facility Contacts

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Salvador Lopez

Role: primary

916-734-4476

Frances Gonzalez, MBS

Role: primary

213-509-7969

Alejandra Torres Sanchez, BA

Role: backup

Cristina Acosta Navarro, BA

Role: primary

628-224-8436

References

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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.

Reference Type BACKGROUND
PMID: 26869664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32028790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15735199 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30854886 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17372149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31336011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28549160 (View on PubMed)

Other Identifiers

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5R01DK135000

Identifier Type: NIH

Identifier Source: secondary_id

View Link

24-41906

Identifier Type: -

Identifier Source: org_study_id

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