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Optimizing the use of continuous glucose monitoring in young children with type 1 diabetes with an adaptive study
Cari Berget1, Kimberly A Driscoll1, Ann Lagges2
1University of Colorado Denver, School of Medicine, Barbara Davis Center for Childhood Diabetes, United States of America.
Insights
This study introduces novel behavioral interventions to help parents manage type 1 diabetes (T1D) in young children. These interventions aim to improve glucose control, device adherence, and reduce parental stress.
Area of Science:
- Pediatric Endocrinology
- Behavioral Science
- Diabetes Management
Background:
- Managing type 1 diabetes (T1D) in young children presents unique developmental challenges for parents, often leading to psychosocial distress.
- Low adherence to diabetes devices and suboptimal glucose control are prevalent in this pediatric population.
Purpose of the Study:
- To test four interventions combining tailored behavioral support and education to optimize diabetes device use.
- To improve glucose control and reduce psychosocial distress in parents of young children with T1D.
- To describe the development and pilot testing of these interventions.
Main Methods:
- Development of four distinct behavioral interventions: two focused on glucose control, two on device adherence.
- A pilot test of the interventions.
- A large-scale, randomized trial with 90 participants using a sequential multiple assignment randomization trial (SMART) design.
Main Results:
- Pilot test results of the developed behavioral interventions will be presented.
- The study will evaluate the effectiveness of the intervention strategy through a SMART design.
Conclusions:
- The study aims to provide a clinically relevant evaluation of a novel intervention strategy for T1D management in young children.
- The SMART design allows for adaptive, individualized intervention adjustments, moving beyond traditional fixed-dose approaches.
Abstract:
Parents of young children with type 1 diabetes (T1D) experience unique, developmental challenges in managing their child's T1D, resulting in psychosocial distress. Only a small portion of young children reach glucose goals and adherence to diabetes devices that help improve T1D management have historically been low in this population. The purpose of this study is to test four interventions that couple developmentally tailored behavioral supports with education to optimize use of diabetes devices, improve glucose control, and reduce psychosocial distress for parents of young children with T1D. The study team designed four behavioral interventions, two aimed at improving glucose control and two aimed at optimizing use of diabetes devices. The goal of this paper is to describe the behavioral interventions developed for this study, including the results of a pilot test, and describe the methods and analysis plan to test this intervention strategy with ninety participants in a large-scale, randomized trial using a sequential multiple assignment randomization trial (SMART) design. A SMART design will permit a clinically relevant evaluation of the intervention strategy, as it allows multiple randomizations based on individualized assessments throughout the study instead of a fixed intervention dose seen in most traditional randomized controlled trials.
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