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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Behavioral: Intervention to increase diabetes technology uptake

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Contact: Ananta Addala; Phone Number: 6504979099; Email: aaddala@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pilot Intervention; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in diabetes technology usage	The investigators will ask you survey questions to understand your attitudes towards diabetes technology at the start and end of the study intervention. The investigators will use a validated survey measure called Diabetes Technology Attitudes Survey to assess this in addition to having conversations with you to learn your beliefs about diabetes technology.	At the start of the study and upon completion of intervention on week 4

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes Technology; Pediatric Type 1 Diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 65313; 1K23DK131342 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No