NCT05488119

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

Improving Outcomes in Pediatric Diabetes: Building the Evidence Base to Inform Effective Diabetes Technology Interventions

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed description

As diabetes technologies have become more innovative and effective in the management of pediatric type 1 diabetes (T1D), research and usage has not engaged all youth living with T1D . Studies have consistently demonstrated lower rates of diabetes technology use in some youth. Although diabetes technology has the potential to improve in pediatric T1D outcomes. This proposal aims to build an evidence base for data-driven interventions designed to increase uptake and utilization of diabetes innovations by addressing barriers and supporting promoters of diabetes technology use. Ananta Addala, D.O., M.P.H, is a physician scientist committed to a career as an independent investigator addressing factors associated with in T1D management and outcomes. Dr. Addala's longstanding research and clinical interests are to promote care for youth with T1D. As a physician with a background in pediatric endocrinology, epidemiology, and behavioral health, Dr. Addala is uniquely qualified to address factors associated with diabetes technology use youth with T1D. Dr. Addala has enlisted a multi-disciplinary mentorship team comprised of experts in the fields of pediatric T1D, health disparities, statistics, and mixed method study design to successfully execute this proposal and launch an independent research career in pediatric T1D. The overall objective of this proposal is to discover factors associated with diabetes technology use in youth with T1D and public insurance and develop a brief intervention, as a means to understand and improve pediatric T1D outcomes. This will be accomplished through two aims. In aim 1, focusing on the family, Dr. Addala will construct an evidence base of barriers and promoters to diabetes technology use in youth with public insurance in order to formulate and test a brief pilot intervention aimed at increasing uptake. In aim 2, this time focusing on the providers, Dr. Addala will construct the evidence base on barriers and promoters to recommending diabetes technology to youth with public insurance in order to formulate and test a brief pilot intervention to increase provider recommendation of diabetes technology. Taken together, findings from Aims 1 and 2 will result in the development of an intervention aimed at increasing diabetes technology uptake and access in youth, thereby improving T1D outcomes. Dr. Addala will use the K23 mentored award to execute an in-depth training plan which includes formal coursework and structured mentorship by her mentors to advance her understanding of mixed methods research, intervention development, and expertise on statistical methods. This proposal is foundational to a future independent clinical trial to evaluate the efficacy of the interventions developed on promoters and barriers of diabetes technology use in youth with T1D.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Intervention to increase diabetes technology uptake	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.

Timeline

• Start date: 2025-04-15
• Primary completion: 2026-06-15
• Completion: 2026-06-30
• First posted: 2022-08-04
• Last updated: 2025-04-25

Locations

1 site across 1 country: United States