Device Use Reimagined Through Education And Mentorship

NCT06546930 | Active Not Recruiting

• 2 other identifiers: 24-419065R01DK135000
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

T1D; Diabetes; Diabetes Mellitus; Type 1

Outcome Measures

Primary Outcomes (10)

• Caregiver Survey

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

  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 Survey

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

  Baseline

• 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 Outcomes (9)

• Caregiver Diabetes Distress Scale (DDS)

  Baseline and End of Study (6-15 months)

• Caregiver Diabetes Family Conflict Scale (DFCS)

  Baseline and End of Study (6-15 months)

• Caregiver Health Care Relationship (QHR)

  Baseline and End of Study (6-15 months)

• Patient Health Utilization

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

• Adolescent Diabetes Distress Scale (DDS)

  Baseline and End of Study (6-15 months)

Other Outcomes (4)

• Socio-Demographic History

  Baseline

• Diabetes Technology Use

  Baseline and End of Study (6-15 months)

• Number of participants completing rountine appointments

  Baseline and End of Study (6-15 months)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Comparator Group

NO INTERVENTION

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

DREAM intervention 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.

Intervention

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: collaborator
• University of California, Davis: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of California, San Francisco: lead

Study Sites (3)

University of California, Davis

Davis, California, 95616, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (7)

• 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.

  PMID: 26869664 BACKGROUND

• 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.

  PMID: 32028790 BACKGROUND

• 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.

  PMID: 15735199 BACKGROUND

• 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.

  PMID: 30854886 BACKGROUND

• 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.

  PMID: 17372149 BACKGROUND

• 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.

  PMID: 31336011 BACKGROUND

• 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.

  PMID: 28549160 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jenise C Wong, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention group (will receive VPG curriculum) versus comparator group (not enrolled)

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 9, 2024
• Study Start: October 11, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)