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Contemp Clin Trials ; 124: 106929, 2023 01.
Article in English | MEDLINE | ID: mdl-36441106

ABSTRACT

Sleep deficiencies amongst individuals with type 1 diabetes mellitus (T1DM) have been linked with dysregulated glycemic control and greater morbidities. Sleep extension (EXT) has been identified as a viable intervention target to improve adolescent outcomes. The intervention aims to emphasize collaborative work with families to engage in behaviors that increase the likelihood of the youth increasing their sleep duration consistently. This study will randomize up to 175 youth with T1DM and at least one caregiver to either an EXT intervention or a family routines support (FRS) consultation. It is hypothesized that the EXT condition will lead to improvements in sleep, which in turn, will contribute to improved glycemic control. The primary endpoint is improved glycemic control assessed via a continuous glucose monitor (CGM) to ascertain average glucose levels across a week, glycemic variability, and percent time in the target range at one month and HbA1c at three months. Analyses will control for co-morbid conditions, including sleep-disordered breathing and obesity. This study will provide the needed data to support addressing sleep as part of the standards of care in youth with T1DM.


Subject(s)
Diabetes Mellitus, Type 1 , Adolescent , Humans , Blood Glucose/analysis , Blood Glucose Self-Monitoring/methods , Diabetes Mellitus, Type 1/therapy , Sleep , Randomized Controlled Trials as Topic
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