BEAD-T1D: Building the Evidence to Address Disengagement in Type 1 Diabetes

NCT05488119 | Recruiting DMC

• 2 other identifiers: 653131K23DK131342
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Youth with public insurance underutilize diabetes care, particularly diabetes technology which is associated with improvement in diabetes-specific outcomes. Thus, we urgently need studies to understand and increase diabetes technology utilization. This proposed research will (1) improve representation of youth in the literature, (2) address the gap in knowledge of barriers and promoters in youth, and (3) identify and address factors associated with diabetes technology uptake and utilization.

Conditions

Type 1 Diabetes

Keywords

Diabetes Technology; Pediatric Type 1 Diabetes

Outcome Measures

Primary Outcomes (3)

• Interviews with you on your feedback on the intervention

  The investigators will ask you questions in a 30-minute interview at the end of the four-week intervention. The investigators will as your feedback on ways the intervention could be more effective and what changes can be made to the intervention so that it is most effective. The investigators will ask you if you are likely to change your diabetes management after completing the intervention.

  Upon completion of intervention on week 4

• Survey questions on your feedback on the intervention

  The investigators will ask you questions in a feedback survey at the end of the four-week intervention. These questions will be developed by the investigators and will ask you ways the intervention could be more effective and what changes can be made to the intervention so that it is most effective. Example questions of what the investigators plan to ask in the survey include: * Was the study explained appropriately? * Was it logistically easy to participate in the study? How could it have improved? * What parts of the intervention were most helpful? * What parts could be cut? * What parts need to be added? * Are there certain types of people who are likely to do better with this intervention?

  Upon completion of intervention on week 4

• Tracking people who complete the study

  The investigators will also keep track of who enrolled in the study and track how many people completed the intervention.

  Through study completion, an average of one year

Secondary Outcomes (1)

• Changes in diabetes technology usage

  At the start of the study and upon completion of intervention on week 4

Study Arms (1)

Pilot Intervention

EXPERIMENTAL

The design for this phase is a prospective pilot study. The intervention will be delivered weekly over a four-week period and will include pre- and post-intervention assessments of survey measurements. The investigators will also evaluate youth diabetes management and technology use. Families will be compensated in a stepwise fashion. Virtual delivery of the pilot intervention will facilitate national recruitment and allow for recruitment during the pandemic or any ensuing limitations to in-person recruitment.

Behavioral: Intervention to increase diabetes technology uptake

Interventions

Intervention to increase diabetes technology uptake BEHAVIORAL

The design for this phase is a prospective pilot study. The intervention modules will be delivered weekly over a four-week period and will include pre- and post-intervention assessments of survey measurements. The investigators will also evaluate youth diabetes management and technology use. Families will be compensated in a stepwise fashion. Virtual delivery of the pilot intervention will facilitate national recruitment and allow for recruitment during the pandemic or any ensuing limitations to in-person recruitment. I will recruit 20 families or providers to participate in the delivery of the pilot intervention designed in Phase 1 of the study via a stakeholder advisory board.

Pilot Intervention

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators will include youth aged 12-21 years in this study. The lower limit of 12 years was selected as this is the age when youth are able to understand and reflect on the topics discussed in the survey measures and focus groups. The upper limit of 21 years was selected as this is the upper limit of public payer coverage (for example, California Children's Services). This aim focuses specifically on the family (youth and parent/guardian) factors that determine diabetes technology use and thus requires that youth are living with their parent/guardian in order to be included in this study. For youth under 18, the investigators will obtain both parental permission and youth assent to participate in the study. For those older than 18, the investigators will obtain consent from the youth alone.

You may not qualify if:

• Diabetes diagnosis in youth other than type 1
• T1D youth less than the age of 12 or older than 21
• non-public payer insurance
• caregivers not living with the youth with type 1 diabetes

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 4, 2022
• Study Start: April 15, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 25, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)