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Optimizing the use of continuous glucose monitoring in young children with type 1 diabetes with an adaptive study design and multiple randomizations.

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.

journal_name

Contemp Clin Trials

journal_title

Contemporary clinical trials

authors

Berget C,Driscoll KA,Lagges A,Lange S,DiMeglio LA,Hannon TS,Woerner SE,Iturralde E,Barley RC,Hanes S,Hood KK,Buckingham BB,Toddler Diabetes Technology Study Group.

doi

10.1016/j.cct.2019.05.008

subject

Has Abstract

pub_date

2019-07-01 00:00:00

pages

60-65

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(19)30090-4

journal_volume

82

pub_type

杂志文章

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